18 results
Page of 2
  • A Phase 2, Multicenter, Open-label Study of Sotorasib (AMG 510) in Subjects with Stage IV NSCLC Whose Tumors Harbor a KRASG12CMutation in Need of First-line Treatment (CodeBreaK 201). - NCT04933695

    Primary: To evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria in subjects who receive sotorasib at either 960 mg daily (QD) or 240 mg QD whose tumors are programmed death-ligand 1 (PD-L1) Tumor Proportion Score (TPS)<1% and/or harbor a serine/threonine kinase 11 (STK11) co-mutation, in a subgroup of subjects with PD-L1 < 1% and in a subgroup of subjects with STK11 co-mutation. Secondary: 1. To evaluate other measures of efficacy. 2. To evaluate the safety and tolerability of sotorasib. 3. Characterize the pharmacokinetics (PK) of sotorasib following administration as an oral tablet formulation.

    View All Details
    • Protocol Number:
      032106

    • Phase:
      Phase II/III

    • Scope:
      National

    • Applicable Disease Sites:
      Lung

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      Sotorasib(AMG 510)

      • Contacts:

      • Rutgers Cancer Institute of New Jersey Prinicipal Investigator: Missak Haigentz MD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Adult (= or > 18 years old) with NSCLC
    • Untreated Stage IV metastatic disease. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvanteoadjuvant therapy was completed greater than 12 months prior to the development of metastatic disease
    • Pathologically documented metastatic NSCLC with KRAS G12C mutation (local confirmation)
    • Programmed death-ligand 1 (PD-L1) TPS Score < 1% and/or serine/threonine kinase 11 (STK11) co-mutation (local confirmation)
    • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
    • No active brain metastases
    • Measurable disease per investigator interpretation using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

    Exclusion Criteria:

    • Mixed small-cell lung cancer and NSCLC histology
    • Active brain metastases from non-brain tumors
    • Myocardial Infarction within 6 months of study Day 1
    • Use of proton-pump inhibitors (PPIs), histamine (H2) receptor antagonists (H2RA), strong inducers of cytochrome P450 (CYP) 3A4 (CYP3A4) or known CYP3A4 sensitive substrates or P-gp substrates
    • Therapeutic or palliative radiation therapy within 2 weeks of study day 1
    • Unable to take oral medication
    • Unable to receive both iodinated contrast for computed tomography (CT) scans and gadolinium contrast for magnetic resonance imagine (MRI) scans

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 3 Study of Pembrolizumab (MK-3475) in Combination with Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib vs Concurrent Chemoradiation Therapy Followed by Durvalumab in Participants with Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer (NSCLC)-MK-7339-012. - NCT04380636

    1) To compare PFS per RECIST 1.1 as assessed by BICR. 2) To evaluate OS. 3) To evaluate the safety and tolerability of pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab plus olaparib compared to concurrent chemoradiation therapy followed by durvalumab. 4) To compare pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab plus olaparib to concurrent chemoradiation therapy followed by durvalumab with respect to ORR and DOR per RECIST 1.1 as assessed by BICR. 5)To evaluate the change from baseline (at Cycle 1) and the TTD in global health status/QoL, cough, chest pain, dyspnea and physical functioning following treatment with pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab plus olaparib compared to concurrent chemoradiation therapy followed by durvalumab.

    View All Details
    • Protocol Number:
      032003

    • Principal Investigator:
      Salma Jabbour M.D.

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Lung

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Pembrolizumab (MK-3475) ETOPOSIDE PACLITAXEL PEMETREXED MEDI4736 (Durvalumab) olaparib placebo pembrolizumab/placebo

      • Contacts:

      • Rutgers University Prinicipal Investigator: Salma Jabbour M.D.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Has pathologically (histologically or cytologically) confirmed diagnosis of NSCLC
    • Has Stage IIIA, IIIB, or IIIC NSCLC by American Joint Committee on Cancer Version 8
    • Is unable to undergo surgery with curative intent for Stage III NSCLC
    • Has no evidence of metastatic disease indicating Stage IV NSCLC
    • Has measurable disease as defined by RECIST 1.1
    • Has not received prior treatment (chemotherapy, targeted therapy or radiotherapy) for Stage III NSCLC; participants who have received neoadjuvant and/or adjuvant therapy for early stage disease are not eligible
    • Has provided a tumor tissue sample (tissue biopsy [core, incisional, or excisional])
    • Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 assessed within 7 days prior to the first administration of study intervention
    • Has a life expectancy of at least 6 months
    • A male participant must agree to use contraception and refrain from donating sperm during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention unless confirmed to be azoospermic (vasectomized or secondary to medical cause). The length of time required to continue contraception for each study intervention is as follows: Olaparib, platinum doublet, and radiotherapy: 90 days
    • A female participant is eligible to participate if she is not pregnant, not breastfeeding, and agrees to use contraception and refrain from donating eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during the treatment period and for at least the time needed to eliminate each study intervention after the last dose of study intervention and agrees to abstain from breastfeeding during the study intervention period and for at least 120 days after the last dose of study intervention. The length of time required to continue contraception for each study intervention is as follows: Pembrolizumab: 120 days Olaparib and platinum doublet: 180 days
    • Has a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours for urine or within 72 hours for serum before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
    • Has had her medical history, menstrual history, and recent sexual activity reviewed by the investigator to decrease the risk for inclusion of a woman with an early undetected pregnancy.
    • Has adequate pulmonary function tests
    • Has adequate organ function
    • Has provided written informed consent

    Exclusion Criteria:

    • Has small cell lung cancer or a mixed tumor with presence of small cell elements
    • Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML
    • Has had documented weight loss >10% (from baseline) in the preceding 3 months
    • Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or for breast cancer
    • Has received prior therapy with an anti-programmed cell death 1 (ant-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti- programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
    • Has received prior therapy with olaparib or with any other polyadenosine 5'diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor
    • Has had major surgery <4 weeks prior to the first dose of study treatment (except for placement of vascular access)
    • Is expected to require any other form of antineoplastic therapy, while on study
    • Has received a live or live attenuated vaccine within 30 days before the first dose of study intervention; administration of killed vaccines is allowed
    • Has received colony-stimulating factors (e.g., granulocyte colony-stimulating factor [GCSF], granulocyte-macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 28 days prior to the first dose of study treatment
    • Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate (e.g. bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study
    • Is currently receiving either strong (eg, itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study
    • Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 grams per day, for at least 2 days before, during, and for at least 2 days after administration of pemetrexed
    • Is unable/unwilling to take folic acid, vitamin B12, and dexamethasone during administration of pemetrexed
    • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
    • The presence of uncontrolled, potentially reversible cardiac conditions, as judged by the investigator or has congenital long QT syndrome
    • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention
    • Has a known additional malignancy that is progressing or has required active treatment within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ (excluding carcinoma-in situ-of the bladder) that have undergone potentially curative therapy
    • Has severe hypersensitivity (≥Grade 3) to study intervention and/or any of its excipients
    • Has an active autoimmune disease that has required systemic treatment in past 2 years
    • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
    • Has an active infection requiring systemic therapy
    • Has a known history of human immunodeficiency virus (HIV) infection
    • Has a known history of Hepatitis B or known active Hepatitis C virus infection
    • Has active tuberculosis (TB; Mycobacterium tuberculosis) and is receiving treatment
    • Has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
    • Is considered a poor medical risk due to a serious, uncontrolled medical disorder or nonmalignant systemic disease in the opinion of the treating investigator
    • Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
    • Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption
    • Has had an allogenic tissue/solid organ transplant

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 3 Study of Pembrolizumab (MK-3475) in Combination with Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib, Compared to Concurrent Chemoradiation Therapy Followed by Placebo in Participants with Newly Diagnosed Treatment-Naive Limited-Stage Small Cell Lung Cancer (LS-SCLC). - NCT04624204

    Primary Objectives: 1. To compare progression free survival (PFS) per RECIST 1.1 as assessed by BICR. 2. To compare overall survival (OS). Secondary Objectives: 1. To evaluate the safety and tolerability of concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib compared to concurrent chemoradiation therapy alone. 2. To evaluate the safety and tolerability of concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab compared to concurrent chemoradiation therapy alone. 3. To compare concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib to concurrent chemoradiation therapy alone with respect to objective response rate (ORR) as assessed by BICR per RECIST 1.1. 4. To compare concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab to concurrent chemoradiation therapy alone with respect to ORR as assessed by BICR per RECIST 1.1. 5. To compare concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib to concurrent chemoradiation therapy alone with respect to duration ofresponse (DOR) as assessed by BICR per RECIST 1.1. 6. To compare concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab to concurrent chemoradiation therapy alone with respect to DOR as assessed by BICR per RECIST 1.1. 7. To evaluate the change from baseline (at cycle I) and the time to true deterioration (TTD) in global health status/quality of life (QoL), cough, chest pain, dyspnea, and physical functioning following treatment with concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib compared to concurrent chemoradiation therapy alone. 8. To evaluate the change from baseline (at cycle I) and the time to true deterioration (TTD) in global health status/quality of life (QoL), cough, chest pain, dyspnea, and physical functioning following treatment with concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab compared to concurrent chemoradiation therapy alone.

    View All Details
    • Protocol Number:
      032105

    • Principal Investigator:
      Salma Jabbour M.D.

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Lung

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      pembrolizumab/placebo Pembrolizumab (MK-3475)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Salma Jabbour M.D.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Has pathologically (histologically or cytologically) confirmed Small Cell Lung Cancer (SCLC). 2. Has Limited-Stage SCLC (Stage I-III, by AJCC 8th Edition Cancer Staging), and can be safely treated with definitive radiation doses. 3. Has no evidence of metastatic disease by whole body positron emission tomography /computed tomography (PET/CT scan), CT or magnetic resonance imaging (MRI) scans 4. Has at least 1 lesion that meets the criteria for being measurable, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) 5. Has not received prior treatment (chemotherapy or radiotherapy or surgery resection) of LS-SCLC. 6. Is not expected to require tumor resection during the course of the study. 7. Must submit a pre-treatment tumor tissue sample (formalin-fixed, paraffin embedded blocks are preferred to slides) including cytologic sample, if tissue sample unavailable. 8. Has Eastern Cooperative Oncology Group (ECOG) Performance score 0 or 1 assessed within 7 days prior to the first administration of study intervention. 9. Has a life expectancy of at least 6 months. 10. Has adequate organ function. 11. Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for the time needed to eliminate each study intervention. 12. Male and female participants who are at least 18 years of age at the time of signing the information consent. 13. Male participants must refrain from donating sperm during the treatment period and for the time needed to eliminate each study intervention.

    Exclusion Criteria:

      1. Has history, current diagnosis, or features suggestive of myelodysplastic syndrome/ acute myeloid leukemia (MDS/AML). 2. Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PDL1), or anti- programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor 3. Has received prior therapy with olaparib or with any other polyadenosine 5'diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor. 4. Had major surgery <4 weeks prior to the first dose of study intervention (except for placement of vascular access). 5. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention. 6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention. 7. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. 8. Has severe hypersensitivity (≥ Grade 3) to study intervention and/or any of its excipients. 9. Has an active autoimmune disease that has required systemic treatment in past 2 years 10. Has a history of (non-infectious) pneumonitis/interstitial lung disease that requires steroids 11. Has an active infection requiring systemic therapy. 12. Has a known history of human immunodeficiency virus (HIV) infection or Hepatitis B or known active Hepatitis C virus infection.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) with or without Pembrolizumab (MK-3475) in Participants with Medically Inoperable Stages I or IIA NonSmall Cell Lung Cancer (NSCLC) (KEYNOTE-867). - NCT03924869

    1) To compare the Event Free Survival for SBRT + pembrolizumab compared to SBRT + placebo 2) To compare Overall Survival for SBRT + pembrolizumab compared to SBRT + placebo 3)To compare the time to death or distant metastases

    View All Details
    • Protocol Number:
      031917

    • Principal Investigator:
      Salma Jabbour M.D.

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Lung

    • Therapies Involved:
      Chemotherapy single agent systemic Radiotherapy

    • Drugs Involved:
      Pembrolizumab (MK-3475)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Salma Jabbour M.D.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Has previously untreated non-small cell lung cancer (NSCLC) diagnosed by histology or cytology and confirmed as Stage I or II (T1 to limited T3, N0, M0) NSCLC (American Joint Committee on Cancer, AJCC) by chest computed tomography (CT) and positron emission tomography (PET) scan. Participants with pericardium invasion, >2 nodules or 2 nodules that cannot be treated in one field (>2 cm apart and/or total planned target volume [PTV] >163 cc) and diaphragm elevation suggestive of phrenic nerve invasion are excluded
    • Cannot undergo thoracic surgery due to existing medical illness(es) as determined by the site's multi-disciplinary tumor board. Medically operable participants who decide to treat with stereotactic body radiotherapy (SBRT) as definitive therapy rather than surgery are also eligible, if patient's unwillingness to undergo surgical resection is clearly documented
    • Has a Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
    • Is able to receive SBRT and does not have an ultra-centrally located tumor
    • Has adequate organ function within 7 days prior to the start of study treatment
    • A female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a) not a women of childbearing potential (WOCBP) OR b) A WOCBP and uses contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least 120 days after the last dose of study intervention
    • Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of radiotherapy: refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or must agree to use contraception per study protocol, unless confirmed to be azoospermic
    • Has a radiation therapy plan approved by the central radiation therapy quality assurance vendor

    Exclusion Criteria:

    • Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4], tumor necrosis factor receptor superfamily member 4 [OX-40], tumor necrosis factor receptor superfamily member 9 [CD137])
    • Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or breast
    • Has received a live vaccine within 30 days prior to the first dose of study intervention
    • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent
    • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
    • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. A prior NSCLC that occurred and was treated curatively at least 2 years prior to the date of the current diagnosis would be considered a separate primary lung cancer, and therefore an additional malignancy. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast c carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
    • Has a known hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
    • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
    • Has a known history of Hepatitis B or known active Hepatitis C virus infection
    • Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). However, replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency), while systemic, will be permitted for study eligibility.
    • Has an active infection requiring systemic therapy
    • Has a known history of human immunodeficiency virus (HIV) infection
    • Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
    • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
    • Has had an allogenic tissue/solid organ transplant

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase II Study of Adjuvant Treatment with Cisplatin-Based Chemotherapy plus Concomitant Atezolizumab in Patients with Stage I (tumors equal to or greater than 4cm), IIA, IIB, and select IIIA [T3N1, T4N0-1] Resected Non-Small Cell Lung Cancer (NSCLC) and the Clearance of Circulating Tumor DNA (ctDNA) Big Ten Cancer Research Consortium BTCRC-LUN19-396. - NCT04367311

    Primary Objective: To estimate the percentage of patients with undetectable circulating tumor DNA (ctDNA) after 4 cycles of adjuvant chemotherapy + Atezolizumab plus up to 13 additional cycles of Atezolizumab in patients with stage I (tumors equal to or greater than 4cm), IIA, IIB, and select IIIA [T3N1, T4N0-1] NSCLC who have detectable ctDNA after surgery, but prior to adjuvant therapy. Secondary Objectives: To estimate the percentage of patients with clearance of ctDNA after 4 cycles of adjuvant chemotherapy + Atezolizumab in patients with stage I (tumors equal to or greater than 4 cm), IIA, IIB, and select IIIA [T3N1, T4N0-1] NSCLC who have undergone surgical resection with detectable ctDNA after surgery. To estimate the percentage of patients with clearance of ctDNA after 8 cycles (4 cycles of adjuvant chemotherapy + Atezolizumab plus 4 additional cycles of Atezolizumab) in patients with stage I (tumors & 4 cm), IIA, IIB, and select IIIA [T3N1, T4N0-1] NSCLC who have undergone surgical resection with detectable ctDNA after surgery. To estimate the percentage of patients with clearance of ctDNA after 12 cycles (4 cycles of adjuvant chemotherapy + Atezolizumab plus 8 additional cycles of Atezolizumab) in patients with stage I (tumors 4 cm), IIA, IIB, and select IIIA [T3N1, T4N0-1] NSCLC who have undergone surgical resection with detectable ctDNA after surgery. To estimate the percentage of patients with clearance of ctDNA during or after adjuvant chemotherapy + Atezolizumab followed by Atezolizumab for up to 13 additional cycles who had no detectable ctDNA after surgery To estimate the percentage of patients with clearance of ctDNA after 4 cycles of adjuvant chemotherapy + Atezolizumab plus up to 13 additional cycles of Atezolizumab in patients with stage I (tumors 4 cm), IIA, IIB, and select IIIA [T3N1, T4N0-1] NSCLC who have undergone surgical resection, regardless of ctDNA status after surgery To estimate the 1 year DFS in all patients treated on study To estimate the 1 year DFS in patients with no detectable ctDNA after 4 cycles of adjuvant chemotherapy + Atezolizumab who had detectable ctDNA after surgery. To estimate the 1 year DFS in patients with detectable ctDNA after 1 year of adjuvant therapy on study

    View All Details
    • Protocol Number:
      032007

    • Phase:
      Phase II/III

    • Scope:
      National

    • Applicable Disease Sites:
      Lung

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Atezolizumab (MPDL3280A) CISPLATIN PEMETREXED DOCETAXEL

      • Contacts:

      • Rutgers Cancer Institute of New Jersey Prinicipal Investigator: Missak Haigentz MD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
    • Age >= 18 years at the time of consent.
    • ECOG Performance Status of 0-1 within 28 days prior to registration.
    • Patients must have undergone complete surgical resection of their stage I (tumors >= 4cm), IIA, IIB, and select IIIA [T3N1-2, T4N0-2] NSCLC according to the AJCC 8th edition with negative margins (R0).
    • Squamous or non-squamous NSCLC histology. Cancers with a histology of "adenosquamous" are considered a type of adenocarcinoma and thus "non-squamous histology".
    • Surgery for this lung cancer must be completed <= 60 days prior to starting treatment.
    • Must have tissue available to perform prospective correlative testing. Tissue block is preferred but 10-15 unstained slides (5 μm thick) are also acceptable. If prior PD-L1 results with Dako 22C3 antibody are not available, an additional 5 unstained slides (4 μm thick) must be submitted.
    • Demonstrate adequate organ function as defined in the protocol; all screening labs to be obtained within 28 days prior to registration.
    • Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months
    • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:
    • Women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 5 months after the final dose of atezolizumab.
    • A woman is considered of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (> or equal to 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.
    • Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
    • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception.
    • Contraception method must begin starting from the time of informed consent until 5 months after treatment discontinuation.
    • For men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below:
    • With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for 5 months after the last dose of study treatment to avoid exposing the embryo. Men must refrain from donating sperm during this same period.
    • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception.
    • As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study

    Exclusion Criteria:

    • Tumors that have any component of small cell or large cell neuroendocrine histology are NOT eligible.
    • Tumors that are known to harbor EGFR mutations or ALK re-arrangements are NOT eligible.
    • Prior chemotherapy, radiation therapy, or immunotherapy is NOT allowed for the treatment of this lung cancer.
    • Prior chemotherapy and/or radiation therapy is permissible for the treatment of other previous cancers, but must have been completed at least 3 months prior to registration for this trial.
    • Other active cancers.
    • Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).
    • Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
    • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
    • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 1 week prior to registration.
    • Has severe hypersensitivity (>= Grade 3) to atezolizumab and/or any of its excipients.
    • Has active or history of autoimmune disease or immune deficiency that includes but is not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis.
    • Known interstitial lung disease that is symptomatic or may interfere with detection or management of suspected drug-related pulmonary toxicity are not permitted.
    • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
    • Has a severe infection within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
    • Has a known history of Human Immunodeficiency Virus (HIV). Note: HIV testing is not required.
    • Has a known history of Hepatitis B or known active Hepatitis C virus infection. Note: If Hepatitis B and Hepatitis C status is unknown, testing is required:
    • Subject must have negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive total HBcAb test.
    • Subject must have negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test. A positive HCV RNA test is sufficient to diagnose active HCV infection in the absence of an HCV antibody test.
    • Has a known history of active TB (Bacillus Tuberculosis).
    • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
    • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
    • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 5 months after the last dose of study drug.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Cooperman Barnabas Medical Center
    • Jersey City Medical Center
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute of New Jersey
  • A Randomized Phase II Trial of Adjuvant Pembrolizumab versus Observation Following Curative Resection for Stage I Non-Small Cell Lung Cancer (NSCLC) with Primary Tumors between 1-4 cm: Big Ten Cancer Research Consortium BTCRC-LUN18-153. - NCT04317534

    Primary Objective: To evaluate whether the addition of adjuvant Pembrolizumab following surgical resection improves disease free survival compared with observation following surgical resection in patients with stage I non- small cell lung cancer (NSCLC) with primary tumors between 1-4 cm in size, regardless of PD-L1 TPS score. Secondary Objectives: - To evaluate whether the addition of adjuvant Pembrolizumab following surgical resection improves overall survival compared with observation in patients with stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm in size, regardless of PD-L1 TPS. - To evaluate the disease-free survival and overall survival rate sat 1year, 2 years, and 3 years on each arm. - To characterize thet oxicity profile of adjuvant Pembrolizumab following surgical resection in patients with stage I non-small cell lung cancer (NSCLC) with primary tumors between 1-4 cm in size.

    View All Details
    • Protocol Number:
      032006

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Lung

    • Therapies Involved:
      Chemotherapy single agent systemic Surgery

    • Drugs Involved:
      Pembrolizumab (MK-3475)

      • Contacts:

      • Rutgers Cancer Institute of New Jersey Prinicipal Investigator: Missak Haigentz MD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • The participant (or legally acceptable representative if applicable) must provide written informed consent for the study. The participant may also provide consent for future unspecified research samples. However, the participant may participate in the study without participating in the future unspecified research sample collection.
    • Males and females age ≥ 18 years at the time of consent.
    • ECOG Performance Status of 0-1 within 28 days prior to registration.
    • Patients must have undergone complete surgical resection of their stage I NSCLC between 4-12 weeks prior to registration and have negative surgical margins (R0).
    • NOTE: Both squamous and non-squamous histologies are allowed into the study. Cancers with a histology of "adenosquamous" are considered a type of adenocarcinoma and thus "non-squamous histology".
    • NOTE: Staging will be according to the AJCC 8th edition.
    • Pathological tumor size must be 1.0 - 4.0 cm in greatest dimension.
    • Surgery for this lung cancer must be completed at least 28 days prior to registration.
    • Must have either previous NGS and PD-L1 results available using the Dako 22C3 antibody or have archival tissue of surgical specimen from current diagnosis available to perform analyses. If prior PD-L1 results with Dako 22C3 antibody are not available from a CLIA-accredited laboratory, subjects must be able to provide 5µm x 4unstained slides for prospective analysis to be used for stratification. If NGS results are not available, subjects must be able to provide at least 10 x 10µm unstained and 1 x 4µm H&E slides from current diagnosis for future NGS and/or other genetic analyses.
    • Demonstrate adequate organ function as defined in the protocol; all screening labs to be obtained within 28 days prior to registration.
    • Females of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. For subjects randomized to the pembrolizumab arm: If there is > 72 hours between the screening test and C1D1, another pregnancy test (urine or serum) must be performed and must be negative before the subject may start C1D1.
    • NOTE: Females are considered of childbearing potential unless: they are postmenopausal; are surgically sterile; or they have a congenital or acquired condition that prevents childbearing. See Section 5.1.4 for definitions.
    • NOTE: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
    • A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
    • Not a woman of childbearing potential (WOCBP) OR
    • A WOCBP who is using a highly effective contraceptive method (failure rate of <1% per year), or is abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) during the intervention period and for at least 120 days after the last dose of study drug. The investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study drug. See contraceptive guidance in Section 5.1.4 of the protocol.
    • As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study

    Exclusion Criteria:

    • Current lung cancer is <1 cm or > 4 cm in size or is stage II, III, or IV.
    • Patients with tumors that are known to harbor actionable EGFR mutations.
    • Prior chemotherapy, radiation therapy, or immunotherapy for the treatment of this lung cancer.
    • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. NOTE: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma in situ, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
    • Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
    • Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
    • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
    • Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
    • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization.
    • Has had an allogenic tissue/solid organ transplant.
    • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
    • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
    • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
    • Has an active infection requiring systemic therapy.
    • Has a known history of Human Immunodeficiency Virus (HIV). Note: HIV testing is not required unless mandated by local health authority.
    • Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Note: Hepatitis B and Hepatitis C testing is not required unless mandated by local health authority.
    • Has active TB (Bacillus Tuberculosis) infection.
    • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
    • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
    • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Cooperman Barnabas Medical Center
    • Community Medical Center
    • Rutgers Cancer Institute of New Jersey
  • Alternating Treatment Plans for Patients with Advanced Thoracic/HN Cancers (ATATcH) - NCT05358548

    Primary Objective: The primary endpoint of this three-arm, parallel phase II study is the percentage of patients receiving 1, 2, 3 and 4 (up to 6 for patients with head and neck cancer) combination chemoimmunotherapy (described in the Schema as Chemo/P) cycles. Secondary Objectives: Overall response rates (at 6 weeks, and best response) Safety/tolerability Progression Free Survival

    View All Details
    • Protocol Number:
      032201

    • Phase:
      Phase II

    • Scope:
      Local

    • Applicable Disease Sites:
      Lung

      • Contacts:

      • Rutgers Cancer Institute of New Jersey Prinicipal Investigator: Missak Haigentz MD

    Read Inclusion & Exclusion Criteria

    Lung Cancer (Arms 1 and 2)
    • Patients must have histologically or cytologically confirmed stage IV NSCLC (includes M1a, M1b, and M1c stage disease, AJCC 8th edition). Patients with Stage IIIB and IIIC disease are eligible if they are not candidates for combined chemotherapy and radiation; such cases should be discussed in a multidisciplinary tumor board.
    • Eligible NSCLC tissue histologies will include squamous cell carcinoma (enrolled and treated in Arm 1), and nonsquamous histologies (e.g. adenocarcinoma, large cell carincoma, etc.; enrolled and treated in Arm 2). Patients with mixed squamous, e.g., adenosquamous, histology will be enrolled and treated on Study Arm 1. Patients with any evidence of Small Cell Carcinoma will be excluded from study participation.
    • Patients may have ANY PD-L1 expression Tumor Proportion Score (TPS) status. Tissue testing for PD-L1 is strongly recommended. If PD-L1 expression TPS is unevaluable or the testing could not be completed, the patient may still be eligible.
    • Patients must have measurable or non-measurable disease. The presence of malignant pleural fluid alone is sufficient to satisfy this eligibility criterion. Baseline imaging assessments and measurements used to evaluate all measurable or non-measurable sites of disease must be done within 4 weeks prior to study registration. NOTE: If patient receives pemetrexed, follow institutional guidelines to drain fluids.
    • Patients must be ≥ 18 years of age.
    • Patients must have an ECOG Performance Status of 0 to 2
    • Patients must NOT have received the following:
    • Prior systemic chemotherapy or immunotherapy for advanced metastatic NSCLC. Patients treated with any prior checkpoint inhibitors for metastatic lung cancer are ineligible. Chemotherapy and immunotherapy for non-metastatic disease (e.g. adjuvant therapy) or immunotherapy for locally advanced Stage III disease is allowed if at least 6 months have elapsed between the last dose of the prior therapy and study registration. Local therapy, e.g. palliative radiation, is allowed as long as a period of 7 days has passed between completion of local

      therapy and study registration. Registration prior to treatment during the 7 days

        is allowed. Palliative radiation must be to non-target lesions.
      • Methotrexate (MTX) given in low doses for non-malignant conditions with last dose at least 14 days prior to date of registration will be allowed. Other low dose chemotherapeutics for non-malignant conditions will be considered, but review by the study chair is required.
      • For Arm 1 (Squamous Lung Cancer): Patients must not have pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE v.5.0. Patients must not have known sensitivity to any component of carboplatin or paclitaxel or nabpaclitaxel.
      • Patients with known EGFR mutations (except exon 20 insertion), BRAF mutations (V600), MET Exon14 skipping or ALK or ROS1 translocations that can be treated with oral tyrosine kinase inhibitors are excluded.
      • Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. Patients with asymptomatic new (at screening) or progressive brain metastases (active brain metastases at screening) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.
      • Patients are eligible if off steroids for at least 7 days prior to protocol treatment.
      • Palliative radiation to non-target lesions (bone metastasis) is allowed if patient develops symptoms.
      • Anticonvulsants are allowed.
      • Patients with asymptomatic, sub-centimeter brain metastasis who at the discretion of investigators do not need immediate CNS directed therapies are eligible.
      • Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
      • Patients must not have known pre-existing and clinically active interstitial lung disease, or a known history of (non-infectious) pneumonitis that required steroids, or current pneumonitis.
      • Patients must not have significant gastrointestinal disorders with diarrhea as a major symptom (e.g. Crohn's disease, malabsorption, etc.)
      • Patients must not have history of auto-immune condition requiring ongoing or intermittent systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
      • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better.
      • Patients must not have any other concomitant serious illness or organ system dysfunction that in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the study drug.
      • Patients must not receive any other investigational agents during the course of therapy.
      • Women must not be pregnant or breast-feeding due to potential harm to the fetus or infant from cytotoxic chemotherapy and the unknown risk of MK-3475 (pembrolizumab). Patients must also not expect to conceive or father children from the time of registration, while on study treatment, and until at least 120 days after the last dose of study treatment. All females of childbearing potential must have a blood test or urine study within 72 hours prior to registration to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point; 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
      • Women of childbearing potential and sexually active males must use an accepted and effective method of contraception or abstain from sexual intercourse from time of registration, while on study treatment, and continue for 120 days after the last dose of study treatment.
      • Patient must have the ability to understand and the willingness to sign a written informed consent document.
      • Patients must meet the following laboratory values within 14 days of randomization:
      • ANC ≥ 1500/mm3
      • Platelets ≥ 100,000/mm3
      • Hgb > 8 g/dL (Note: Patient may be transfused to meet this criteria)
      • PT/INR ≤ 1.5
      • Or if patient on therapeutic anticoagulation with Warfarin, PT/INR ≤ 3.0
      • Patients must have adequate liver function as determined by the following tests obtained within 14 days of randomization:
      • Total Bilirubin ≤ 1.5 mg/dL
      • SGOT (AST) < 5X upper limit of normal (ULN)
      • SGPT (ALT) < 5X upper limit of normal ULN)
      • Patients must have adequate renal function as determined by the following tests obtained within 14 days prior to randomization: Calculated creatinine clearance ≥ 45ml/min to be eligible to receive pemetrexed Serum creatinine ≤ 1.5X institutional upper limit of normal (ULN)
      • Patients must not have a known history of active tuberculosis (TB).
      • Patients must not have a diagnosis of immunodeficiency or receive systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of protocol treatment.
      • Patients must not have received a live vaccine within 30 days prior to randomization. Seasonal flu vaccines that do not contain live virus are permitted. COVID-19 vaccination per guidelines for cancer patients is permitted and encouraged.
      • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
      • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable or on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Head and Neck Cancer (Arm 3)
      • Patient must have histologically confirmed recurrent/metastatic squamous cell carcinoma of the head and neck (HNSCC) (excluding SCC of salivary glands, nasopharynx and skin) that is considered incurable by local therapies. The eligible primary tumor locations include oropharynx, oral cavity, hypopharynx, and larynx. Unknown primary site will also be considered eligible.
      • Patients may have ANY PD-L1 expression Tumor Proportion Score (CPS) status. Tissue testing for PD-L1 IHC on samples demonstrating recurrent/metastatic disease is strongly recommended, though testing may be performed on initial diagnostic specimens. If PD-L1 expression CPS is unevaluable or the testing could not be completed, the patient will still be considered eligible.
      • Tumor expression of p16 by immunohistochemistry is highly desirable for patients with Oropharyngeal primaries. Positive p16 expression is defined as strong and diffuse nuclear and cytoplasmic staining in 70% or more of the tumor cells. If HPV status was previously tested using this method, no additional testing is required. If results are not available or are not possible patient will still be considered eligible. Note: Oral cavity, hypopharynx, and larynx cancer are not required to undergo HPV testing by p16 IHC as by convention these tumor locations are assumed to be HPV negative.
      • Patients must have measurable or non-measureable disease. The presence of malignant pleural fluid or bone disease alone is sufficient to satisfy this eligibility criterion. Baseline imaging assessments and measurements used to evaluate all measurable or non-measurable sites of disease must be done within 4 weeks prior to study registration. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
      • Patient must be ≥ 18 years of age.
      • Patient must have an ECOG performance status 0-2.
      • Patients must NOT have received the following:
      • Prior systemic chemotherapy or immunotherapy for recurrent/metastatic head and neck squamous cell carcinoma. Patients treated with any prior checkpoint inhibitors for recurrent/metastatic head and neck cancer are ineligible. NOTE: Patients who have received prior chemotherapy or cetuximab with radiation for curative intent treatment of locally advanced head and neck cancer whose disease has progressed after at least 6 months will be eligible.
      • Methotrexate (MTX) given in low doses for non-malignant conditions with last dose at least 14 days prior to date of registration will be allowed. Other low dose chemotherapeutics for non-malignant conditions will be considered, but review by the study chair is required.
      • Patients who have endocrinopathies but are now stable on hormone supplementation and/or a daily prednisone dose of ≤ 10 mg (or equivalent doses of another glucocorticoid), will be permitted on this trial.
      • Patient must not have a severe infection within 4 weeks prior to randomization, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia. Patients must not have active tuberculosis.
      • Patient must not have a history of non-infectious pneumonitis requiring steroids at doses greater than or equal to 10 mg per day of prednisone or the equivalent on first line immunotherapy.
      • Patient must not have a history of solid organ transplantation or stem-cell transplant.
      • Patient must not be on immunosuppressive medication within 7 days prior to randomization except for: intranasal, inhaled, or topical steroids, local steroid injection, systemic corticosteroids at doses less than or equal to 10 mg per day of prednisone or the equivalent, or steroids used as premedication for hypersensitivity reactions.
      • Patient must not have an active autoimmune disease that requires systemic treatment within 2 years prior to randomization. Patients who are receiving replacement therapy for adrenal or pituitary insufficiency will not be excluded.
      • Patient must not have had a severe hypersensitivity reaction to any of the drug components used on this protocol or to chimeric or humanized antibodies or fusion proteins.
      • Patient must not have received any live vaccine within 30 days prior to randomization and while participating in the study. Live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral) vaccine. Patients are permitted to receive inactivated vaccines and any non-live vaccines including those for the seasonal influenza and COVID-19 (Note: intranasal influenza vaccines, such as Flu-Mist® are live attenuated vaccines and are not allowed). If possible, it is recommended to separate study drug administration from vaccine administration by about a week (primarily, in order to minimize an overlap of adverse events).
      • Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
      • Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for 120 days after last dose of study therapy.
      • Patient must have the ability to understand and the willingness to sign a written informed consent document.
      • Patient must have adequate organ and marrow function as defined below (these labs must be obtained ≤ 14 days prior to protocol randomization):
      • Absolute neutrophil count (ANC) ≥ 1,500/mcL
      • Platelets ≥ 100,000/mcL
      • Hgb > 8 g/dL (Note: Patient may be transfused to meet this criteria)
      • Total bilirubin ≤1.5xULN OR Direct bilirubin ≤ULN for subjects with total bilirubin levels >1.5xULN
      • AST (SGOT)/ALT (SGPT) ≤ 2.5 × institutional ULN (< 5.0 x institutional ULN if hepatic metastases present)
      • Creatinine ≤ 1.5 x institutional ULN OR Measured or Calculated Creatinine Clearance ≥60 mL/min for subject with creatinine levels >1.5x institutional ULN
      • PT/INR ≤ 1.5
      • Or if patient on therapeutic anticoagulation with Warfarin, PT/INR ≤ 3.0
      • Patients with uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L, calcium > 12 mg/dL) must have their calcium levels corrected prior to randomization.
      • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial.
      • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
      • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
      • Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. Patients must not have untreated brain metastases or leptomeningeal disease.
      • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
      • Patient must not have significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to randomization, or unstable arrhythmia or unstable angina at the time of randomization.
      • Patient must not receive any other chemotherapy, immunotherapy, antitumor hormonal therapy (excluding contraceptives and replacement steroids), radiation therapy, or experimental medications while on protocol treatment. Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to randomization and patients must be recovered from the effects of radiation (there is no required minimum recovery period).
      • Patient must not have any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of the agents used in this protocol, may affect the interpretation of the results, or may render the patient at high risk from treatment complications.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Cooperman Barnabas Medical Center
    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Community Medical Center
    • Newark Beth Israel Medical Center
    • Jersey City Medical Center
    • RWJ University Hospital Hamilton
    • Rutgers Cancer Institute of New Jersey
  • BTCRC-LUN-127: A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients with Recurrent Small Cell Lung Cancer: Big Ten Cancer Research Consortium. - NCT03575793

    Primary: Phase I: The primary objective of the Phase I dose escalation study is to establish the maximum tolerated dose (MTD) of plinabulin in combination with nivolumab and ipilimumab for patients with recurrent SCLC. Phase 2: The primary objective of the Phase II, 2-arm randomized study is to determine if the addition of plinabulin to double checkpoint inhibition (PD-1 and CTLA-4) for recurrent SCLC will improve progression-free survival (PFS, the time from treatment assignment to the date of the first documented tumor progression, or death due to any cause, whichever occurred first). Secondary: - To assess toxicity and tolerability of the combination of nivolumab, ipilimumab and plinabulin. - To compare the frequency of immune-related adverse events (irAEs) between the nivolumab/ipilimumab arm vs the nivolumab/ipilimumab/plinabulin arm. - To determine the proportion of patients with a confirmed objective response in the 2 arms of the Phase II part (defined as the number of patients with a best overall response of complete response or partial response divided by the number of assigned patients). - To estimate clinical benefit rate (CBR: complete response, partial response, or stable disease). - To estimate 6-month (? 4 weeks) PFS. - To estimate overall survival (OS) and 1-year OS. Exploratory: - To compare biomarkers of inflammation (high sensitivity C-reactive protein [hsCRP], erythrocyte sedimentation rate [ESR], serum amyloid A [SAA]) between the nivolumab/ipilimumab arm vs the nivolumab/ipilimumab/plinabulin arm. - To correlate tumor mutational burden with PFS and ORR

    View All Details
    • Protocol Number:
      031805

    • Principal Investigator:
      Jyoti Malhotra MD, MPH

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Lung

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      IPILIMUMAB (MDX-010) Plinabulin Opdivo (Nivolumab)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Jyoti Malhotra MD, MPH

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      The patients must satisfy all of the following inclusion/exclusion criteria in order to be eligible for the study:
    • Must have signed and dated written informed consent form in accordance with regulatory and institutional guidelines.
    • Males and females aged >18 years at time of consent.
    • Histological or cytological confirmed extensive-stage SCLC
    • Patients who progressed after at least 1 platinum-based chemotherapy regimen. Patients with platinum resistance (defined as recurrence or progression of disease within 90 days of completion of the platinum-based regimen) are eligible. For phase II, patients also must have been treated with at least one prior line of PD-1/PD-L1 therapy.
    • Measurable disease according to RECIST v1.1 (Section 8) obtained by imaging within 28 days prior to study registration.
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 14 days before registration and minimum life expectancy of at least 12 weeks.
    • Treatment to be initiated at least 2 weeks since last dose of prior systemic anticancer therapy (chemotherapy, radiation, and/or surgery.
    • Recovery to grade 1 of any clinically significant toxicity (excluding alopecia, grade 2 fatigue, vitiligo, endocrinopathies on stable replacement therapy) prior to initiation of study drugs.
    • Female patients of childbearing potential have a negative pregnancy test at baseline. Females of childbearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti estrogens, or ovarian suppression.
    • Women of childbearing potential (i.e., menstruating women) must have a negative urine pregnancy test (positive urine tests are to be confirmed by serum test) documented within 14 days of study registration and within the 24-hour period prior to the first dose of study drug.
    • Sexually active women of childbearing potential enrolled in the study must agree to use 2 forms of accepted methods of contraception during the course of the study and for 23 weeks after their last dose of study drug. Effective birth control includes (a) intrauterine device plus 1 barrier method; (b) on stable doses of hormonal contraception for at least 3 months (e.g., oral, injectable, implant, transdermal) plus one barrier method; (c) 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm); or (d) a vasectomized partner.
    • For male patients who are sexually active and who are partners of premenopausal women: agreement to use 2 forms of contraception as in criterion 9b above during the treatment period and for 31 weeks after the last dose of study drug.
    • Adequate laboratory values.
    • Absolute neutrophil count ≥1,000/µL
    • Platelet count ≥100,000/µL
    • Hemoglobin ≥9.0 g/dL
    • Total bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN for subjects with Gilbert's disease
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 x ULN (≤5 x ULN if evidence of hepatic involvement by malignant disease)
    • Creatinine ≤ 1.5 x ULN or estimated glomerular filtration rate (eGFR) ≥40 mL/min/1.73m2
    • Lipase and Amylase ≤1.5 x ULN. Subjects with Lipase >1.5 x ULN may enroll if there are neither clinical nor radiographic signs of a pancreatitis.

    Exclusion Criteria

      Patients with any of the following will be excluded from participation in the study.
    • Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids. Prior history of radiation pneumonitis is allowed if pneumonitis was restricted to the field of radiation.
    • History of ileus or other significant gastrointestinal disorder known to increase the risk of ileus or chronic bowel hypomotility
    • Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 23 weeks (female) or 31 weeks (male) after the last dose of study drug.
    • Must not have received CTLA-4 targeted therapy previously
    • Treatment with any investigational agent within 28 days prior to registration for protocol therapy. Vaccination for SARS-CoV-2 is allowed as well as any therapy as required for the treatment of active COVID 19 infection.
    • Known active symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with neurological symptoms must undergo a head computed tomography (CT) scan or brain magnetic resonance imaging (MRI) to exclude brain metastasis. Patients whose brain metastases have been treated may participate provided there is no evidence of progression for at least 2 weeks after CNS-directed treatment, as ascertained by clinical examination or brain imaging.
    • Known history of human immunodeficiency virus (HIV) or active hepatitis B (by surface antigen expression or polymerase chain reaction [PCR]) or active hepatitis C (by PCR) infection. NOTE: HIV testing is not required; Hepatitis B and C testing are required at screening.
    • Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study registration.
    • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Vitiligo, alopecia, hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment, celiac disease controlled by diet alone or conditions not expected to recur in the absence of an external trigger are permitted.
    • A condition requiring systemic treatment with corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to administration of study drugs.
    • History of psychiatric illness or social situations that would limit compliance with study requirements. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
    • Prior malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) unless a complete remission was achieved at least 2 years prior to study entry.
    • Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class III-IV within 6 months prior to their first dose of study drugs.
    • Evidence of ongoing inadequately controlled hypertension (defined as baseline systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg).
    • Any active grade 3 or higher viral, bacterial, or fungal infection within 2 weeks of the first dose of the study drugs. Routine antimicrobial prophylaxis is permitted.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Monmouth Medical Center
    • Community Medical Center
    • Rutgers Cancer Institute of New Jersey
  • Cancer treatment and survivorship experiences among Southern New Jersey residents.

    The primary objective of this project is to conduct a survey of cancer survivors to understand cancer burden, treatment outcomes, care needs, cancer prevention practices, health care access, and health information seeking behaviors of persons living in Southern New Jersey (Atlantic, Burlington, Camden, Cape May, Cumberland, Gloucester, Mercer, Ocean, and Salem counties). To date, health needs of cancer survivors who are residents of these Southern New Jersey counties remain largely unexplored. Specific Aim 1: To determine the feasibility of conducting research on the access and needs of patients diagnosed with cancers who reside in the New Jersey counties outlined. Specific Aim 2: To characterize the cancer burden, quality of life characteristics, care needs, cancer prevention practices, health care access, survivorship care experiences, cancer surveillance, and health information seeking behaviors of patients diagnosed with cancers who reside in the New Jersey counties outlined.

    View All Details
    • Protocol Number:
      131803

    • Principal Investigator:
      Sharon Manne PhD

    • Phase:
      N/A

    • Scope:
      Local

    • Applicable Disease Sites:
      Colon,Breast - Female,Melanoma, Skin,Ovary,Lung,Rectum,Cervix,Other Female Genital,Thyroid,Prostate,Urinary Bladder

      • Contacts:

      • Rutgers University Prinicipal Investigator: Sharon Manne PhD
    • Rutgers Cancer Institute of New Jersey
  • Cardiotoxicity in Locally Advanced Lung Cancer Patients Treated with Chemoradiation Therapy: A Prospective Longitudinal Cohort - NCT04305613

    Primary Objectives: To quantify RT-related changes in circulating biomarkers of CV stress, inflammation and vascular dysfunction, and to define the associations between RT dose-volume measures and biomarkers. To quantify RT-related changes in imaging-derived measures of CV function and perfusion, and to define the associations between RT dose-volume measures and CV function and perfusion. To determine the prognostic value of biologic, imaging, and RT dose-volume measures as indicators of adverse CV outcomes, by defining the associations between early changes in these measures and CV outcomes. Secondary Objectives: To determine the associations between changes in CV biomarkers and QOL and activity measures. To determine the associations between changes in measures of cardiac function and perfusion and QOL and activity measures To determine the associates between changes in RT dose volume measures and QOL and activity measures

    View All Details
    • Protocol Number:
      152101

    • Principal Investigator:
      Salma Jabbour M.D.

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Lung

      • Contacts:

      • Rutgers University Prinicipal Investigator: Salma Jabbour M.D.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • At least 18 years of age
    • Histologically confirmed, locally advanced Stage II, IIIA, or IIIB non-small cell lung cancer with inoperable disease
    • Planned to receive treatment with definitive concurrent chemoradiation with curative intent
    • Able to give written informed consent

    Exclusion Criteria:

    • Pregnant or breast-feeding
    • Prior thoracic radiotherapy that would result in overlap of radiation therapy in the heart
    • Prior treatment with anthracyclines
    • ECOG performance status greater than 2
    • Vulnerable patients, including pregnant women and prisoners
    • Contraindication to rest/vasodilator stress PET/CT, including: asthma with ongoing wheezing at time of enrollment; known 2nd or 3rd degree atrioventricular block without a pacemaker, or sick sinus syndrome; systolic blood pressure less than 90mmHg; known hypersensitivity to Regadenoson or adenosine; profound sinus bradycardia (heart rate less than 40bpm).

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • Detection & Characterization of Circulating Tumor Cells in Adenoid Cystic Carcinoma

    1. Prove that Circulating tumor cells (CTCs) can be reliably detected in peripheral blood of ACC (adenoid cystic carcinoma) patients using Epic Sciences proprietary algorithms at different stages of the disease: 1) newly diagnosed patients without evidence of metastases, 2) patients who have completed local treatment with surgery with or without postoperative RT without evidence of metastases, 3) patients with known metastatic disease. 2. Characterize and quantify Surface protein biomarker expression on CTCs in patients with ACC

    View All Details
    • Protocol Number:
      031806

    • Principal Investigator:
      Sung Kim M.D

    • Phase:
      N/A

    • Scope:
      Local

    • Applicable Disease Sites:
      Lung,Esophagus,Thyroid,Larynx

      • Contacts:

      • Rutgers University Prinicipal Investigator: Sung Kim M.D
    • Rutgers Cancer Institute of New Jersey
    • Rutgers New Jersey Medical School
  • EA5181: Randomized Phase III Trial of MEDI4736 (durvalumab) as Concurrent and Consolidative Therapy or Consolidative Therapy Alone for Unresectable Stage 3 NSCLC. - NCT04092283

    Primary Endpoints: The primary objective of this trial is to evaluate whether there is an improvement in overall survival with concomitant chemotherapy/radiation therapy/MEDI4736 (durvalumab) followed by one year (12 cycles) of MEDI4736 (durvalumab) as compared to concomitant chemotherapy/radiation followed by one year (12 cycles) of MEDI4736 (durvalumab). Secondary Endpoints: 1. Best objective response rate (ORR): To evaluate the difference in response using RECIST 1.1 criteria to assess whether or not MEDI4736 (durvalumab) added to concomitant chemo/radiation results in an improvement in response rates. 2. Progression-free survival (PFS): To evaluate any difference in PFS with concomitant chemotherapy/radiation therapy/MEDI4736 (durvalumab) followed by one year (12 cycles) of MEDI4736 (durvalumab) as compared to concomitant chemotherapy/radiotherapy followed by one year of MEDI4736 (durvalumab). 3. Recurrence patterns (RP) (local vs distant): To evaluate whether the incidence of recurrence and recurrence pattern is affected by giving MEDI4736 (durvalumab) during chemo/radiation. Local recurrence will be defined as any recurrence confined to the ipsilateral lung or the N1-N3 nodal areas. All other recurrences will be considered distal recurrences. 4. Toxicity: To evaluate any difference in toxicity when MEDI4736 (durvalumab) is added.

    View All Details
    • Protocol Number:
      032013

    • Principal Investigator:
      Salma Jabbour M.D.

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Lung

    • Therapies Involved:
      Chemotherapy multiple agents systemic Chemotherapy single agent systemic Radiotherapy

    • Drugs Involved:
      MEDI4736 (Durvalumab) PACLITAXEL CARBOPLATIN

      • Contacts:

      • Rutgers University Prinicipal Investigator: Salma Jabbour M.D.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • STEP 1 INCLUSION ELIGIBILITY CRITERIA - CONCURRENT THERAPY
    • Patient must have one of the following:
    • Newly diagnosed stage IIIA/B/C non-small cell lung cancer (NSCLC) (per the American Joint Committee on Cancer [AJCC] 8th edition) that is unresectable and is histologically and/or cytologically confirmed
    • Nodal recurrence after surgery for early stage NSCLC
    • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    • Body weight > 30 kg of patients
    • Patient must not have unintentional weight loss > 10% within 30 days prior to registration
    • Patient must have a baseline electrocardiography (ECG) obtained within 6 weeks of registration
    • Patient must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. Baseline imaging assessments and measurements used to evaluate all measurable or non-measurable sites of disease must be done within 4 weeks prior to registration
    • Absolute neutrophil count (ANC) >= 1500 cells/uL (obtained =< 7 days prior to registration)
    • White blood cells (WBC) counts >= 2500/uL (obtained =< 7 days prior to registration)
    • Platelet count >= 100,000/uL (obtained =< 7 days prior to registration)
    • Hemoglobin >= 9.0 g/dL (obtained =< 7 days prior to registration)
    • Total bilirubin =< 1.5 x upper limit of normal (ULN) with the following exception: patients with known Gilbert disease who have serum bilirubin level < 3 x ULN may be enrolled (obtained =< 7 days prior to registration)
    • Aspartate aminotransferase (AST) and alanine transaminase (ALT) =< 3.0 x ULN (obtained =< 7 days prior to registration)
    • Serum creatinine =< 1.5 x ULN or creatinine clearance >= 45 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation (obtained =< 7 days prior to registration)
    • Patient must have pulmonary function tests (PFTs) with both forced expiratory volume in 1 second (FEV1) and diffusion capacity of the lung for carbon monoxide (DLCO) >= 40% of predicted, obtained within 5 months of registration
    • Patient is expected to have lung volume (V)20 of =< 35%, after radiation oncologist views pre-treatment work up
    • Patients with nodal recurrence after surgery for early-stage NSCLC are eligible if the following criteria are met:
    • No prior chemotherapy or radiation was ever administered for this lung cancer originally or for recurrence prior to entering this protocol
    • Prior curative-intent surgery was at least 90 days prior to the nodal recurrence
    • No prior radiation was administered to the region of study cancer that would cause overlap of treatment fields
    • Patients who are human immunodeficiency virus (HIV) positive may participate in the study IF they meet all of the following eligibility requirements:
    • They must be stable on their anti-retroviral regimen, and they must be healthy from an HIV perspective
    • They must have a CD4 count of greater than 250 cells/mcL, within 6 months of registration
    • They must not be receiving prophylactic therapy for an opportunistic infection
    • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Patients must not have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration
    • Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. Patients must also not expect to conceive or father children from the time of registration, while on study treatment, and until 90 days after the last dose of study treatment
    • All patients of childbearing potential must have a negative blood test or urine study, with a minimum sensitivity 50 mlU/L or equivalent units of human chorionic gonadotropin (HCG), within 7 days prior to registration to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e. has had menses at any time in the preceding 24 consecutive months)
    • Patients of childbearing potential (WOCBP) and patients who are sexually active with WOCBP must use accepted and highly effective method(s) of contraception during sexual intercourse for at least one week prior to the start of treatment, during protocol treatment, and continue for 90 days after the last dose of protocol treatment
    • Highly effective methods of contraception include Etonogestrel-releasing implants (Implanon or Norplant), Intravaginal: Ethinylestradiol/etonogestrel-releasing intravaginal devices: e.g., NuvaRing, injection: Medroxyprogesterone injection: e.g., Depo-Provera, combined pill: Normal and low dose combined oral contraceptive pill, patch: Norelgestromin/ethinylestradiol-releasing transdermal system: e.g., Ortho Evra, Minipillc: Progesterone based oral contraceptive pill using desogestrel: Cerazette is currently the only highly effective progesterone based pill
    • Methods that are considered inadequate include male or female condom with or without spermicide; female cap, diaphragm, or sponge with or without spermicide; non-copper containing intrauterine device; progestogen-only oral hormonal contraceptive pills where inhibition of ovulation is not the primary mode of action [excluding Cerazette/desogestrel which is considered highly effective]; and triphasic combined oral contraceptive pills)
    • STEP 2 INCLUSION ELIGIBILITY CRITERIA - CONSOLIDATION
    • Patients with any > grade 2 non-hematologic or > grade 3 hematologic toxicities must recover to grade 2 (or less) within 45 days after the end of concurrent chemo/radiation, with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria

    Exclusion Criteria:

    • STEP 1 EXCLUSION ELIGIBILITY CRITERIA - CONCURRENT THERAPY
    • Patient must not have any active, known or suspected autoimmune disease and neuromuscular paraneoplastic syndromes including, but not limited to myasthenia gravis, Lambert-Eaton myasthenic syndrome, limbic encephalitis, myositis, Guillain-Barré, systemic lupus erythematosus, and systemic sclerosis. Patients with type I diabetes mellitus requiring insulin, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are eligible
    • Patient must not have a history of active hepatitis B (chronic or acute) or hepatitis C infection. Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for hepatitis C virus ribonucleic acid (HCV RNA)
    • Patient must not have a known active tuberculosis infection
    • Patient must not have any severe infections within 4 weeks prior to registration including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
    • Patient must not have signs or symptoms of severe infection (sepsis) within 2 weeks prior registration
    • Patient must not have been treated with systemic immunostimulatory agents (including but not limited to interferon-a [IFN-a], interleukin [IL]-2) within 6 weeks or five half-lives of the drug (whichever is shorter) prior to registration; or treated with an investigational agent within 4 weeks prior to registration (or within five half-lives of the investigational agent, whichever is longer)
    • Patient must not have a history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
    • Patient must not have been treated with systemic immunosuppressive medications (equivalent to > 10 mg prednisone per day) or other immunosuppressive medications within 7 days of registration. Inhaled or topical steroids and adrenal replacement steroid doses equivalent to > 10 mg prednisone per day are permitted in the absence of active autoimmune disease
    • Patient must not have had a prior allogeneic bone marrow transplantation or prior solid organ transplantation
    • Patient must not have a history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan within 4 weeks of registration
    • Patient must not have had any prior systemic treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways
    • Patient with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment and severity of cardiac symptoms. Symptoms should be stable over the past 3 months. Specifically, patient must not have coronary artery bypass grafting, myocardial infarction, acute coronary syndrome severe/unstable angina, stroke, transient ischemic attack, or heart failure hospitalization within 3 months prior to registration
    • Patient must not have an uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent
    • Patient must not have received a live, attenuated vaccine within 4 weeks prior to registration
    • Patient must not have had past radiation to the current intended treatment site
    • Patient must not donate blood while on study treatment
    • STEP 2 EXCLUSION ELIGIBILITY CRITERIA - CONSOLIDATION
    • Patients must not receive any non-protocol anti-cancer therapy after the end of chemo/radiation or during consolidation
    • Patients with suspected cases of >= grade 2 pneumonitis (non-infectious) are not eligible for consolidative MEDI4736 (durvalumab) and will proceed onto follow-up instead
    • Patients must not have disease progression on the first post-treatment (for concurrent chemo/radiation) chest CT scan, which must be obtained within 14 days after the last dose of radiation therapy. If so, the patient is not eligible for consolidative MEDI4736 (durvalumab) and will proceed onto follow-up instead

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Cooperman Barnabas Medical Center
    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Community Medical Center
    • Jersey City Medical Center
    • RWJ University Hospital Hamilton
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute of New Jersey
Page of 2