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  • A Dose Finding Study of CycloSam? (153Sm-DOTMP) to Treat Solid Tumor(s) in the Bone or Metastatic to the Bone (Metastatic Prostate, Breast, and Lung, Osteosarcoma, Ewings Sarcoma, and other solid tumor(s) to the bone all eligible). - NCT06008483

    The primary objective of this study is: To determine the MTD of CycloSam?, given as a tandemly administered pair of doses to subjects with one or more solid tumor(s) in the bone or metastatic solid tumors to the bone that are visible on bone scan. The secondary objectives of this study are: 1. To describe the toxicity and long-term effects of infusional CycloSam?; 2. To assess the clinical response of solid tumors to the bone or metastatic to the bone to therapy with infusional CylcoSam?; 3. To describe the distribution of absorbed doses delivered to each targeted lesion and the distribution of lesion equivalent uniform dose delivered to each subject; 4. To observe overall survival and time to progression in subjects treated with infusional CycloSam?, and model any relationship between total absorbed dose and progression; 5. To assess the extent of pain palliation using a visual analogue scale (VAS) in subjects treated with infusional CycloSam?.

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    • Protocol Number:
      052201

    • Principal Investigator:
      Sanjay Goel

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Breast,Prostate,Lung,Any Site

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      CycloSam (153Sm-DOTMP)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Sanjay Goel

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Subjects will be between the ages of 15 and 75, inclusive. 2. Subjects must have a histologically confirmed diagnosis of a solid tumor metastatic to bone, or a histologically confirmed diagnosis of a solid tumor to the bone or metastatic to the bone. 3. Subjects must have measurable disease on anatomic imaging that is also avid for phosphonate compounds as demonstrated by a positive 99mTc diphosphonate bone scan. Not all lesions must be positive on bone scan. 4. Adequate organ function, including: i. Adequate renal function, defined as a measured creatinine clearance >70 mL/min/1.73 m2 or normal radioisotope glomerular filtration rate (GFR). ii. Adequate hematologic function, defined as a platelet count >100,000 cells/mm3 and an absolute neutrophil count (ANC) >1,000 cells/mm3. 5. Life expectancy of at least eight weeks. 6. Karnofsky performance status >50%. 7. Subjects must have adequately recovered from the effects of any prior chemotherapy, as determined by the treating physician and study team, based in part on organ function defined above. Toxicities from previous therapies must have recovered to CTCAE v5.0 grade ≤1. Subjects with Grade 2 anemia per CTCAE v5.0 will be permitted as long as the subject has normal cardiac function. 8. Adequate cardiac function. Subjects with previously identified cardiac disease will be eligible, as 153Sm-DOTMP is not expected to cause cardiac dysfunction and is only expected to result in very transient hypocalcemia. 9. A stem cell product collected either by peripheral stem cell mobilization or bone marrow harvest prior to the infusion of CycloSam® must be available, prior to trial entry. A minimum of 2 x 106 CD34+ cells/kg ideal body weight are required. 10. Female subjects of child-bearing potential (defined as premenopausal and capable of becoming pregnant) must have a negative serum pregnancy test at the Screening visit. Females must be surgically sterile, postmenopausal for at least one year prior to Screening (no other medical cause involved) with a Follicle Stimulating Hormone (FSH) level of greater than 40 mIU/mL or must be using a highly effective method of birth control and agree to its use for at least 30 days following the last dose of 153Sm-DOTMP. Highly effective methods of contraceptive are defined as tubal ligation or an approved hormonal contraceptive such as oral contraceptives, patches, implants, injections, rings, or hormonally-impregnated intrauterine device. 11. Male subjects with partners of child-bearing potential must agree to use highly effective methods of contraception for at least 90 days after the last dose of 153Sm-DOTMP. 12. The subject and/or the subject's legally authorized guardian, if the subject is a minor, must acknowledge in writing that informed consent to become a study subject has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services. 13. Subjects must have previously received effective treatment for their underlying disease and have no potentially curative options available. 14. The concurrent use of hormonal therapies or bisphosphonates is acceptable, provided the latter do not render target lesions invisible on 99mTc bone scan. Subjects will have the option to re-screen up to once more after seven days if they do not initially meet all of the inclusion criteria

    Exclusion Criteria:

      1. Subject is pregnant or breastfeeding. 2. Subject is sexually active and does not agree to use accepted, effective forms of contraceptive. 3. Subject has received prior radiotherapy to all known areas of current active disease. 4. Subject has a body mass index (BMI) > 50 kg/m2.

    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 1b Study Evaluating the Safety and Efficacy of First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects with Extensive Stage Small Cell Lung Cancer. - NCT05361395

    Primary Objective: To evaluate the safety, tolerability, and determine the recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) of tarlatamab in combination with programmed death ligand 1 (PD-L1) inhibition with or without chemotherapy. Secondary Objectives: To evaluate the 6-month progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), disease control, and overall survival (OS) of tarlatamab in combination with PD-L1 inhibition and chemotherapy. To characterize the pharmacokinetics (PK) of tarlatamab combination with PD-L1 inhibition with or without chemotherapy.

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    • Protocol Number:
      032209

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Lung

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Tarlatamab Atezolizumab (MPDL3280A)

      • Contacts:

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

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Participant has provided informed consent prior to initiation of any study specific activities/procedures.
    • Age greater than or equal to 18 years old at the same time of signing the informed consent.
    • Histologically or cytologically confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC) and no prior systemic treatment for ES-SCLC.
    • Participants with prior treatment for limited-stage SCLC (LS-SCLC) are permitted.
    • Eastern Cooperative Oncology Group (ECOG) 0 to 1.
    • Participants with treated asymptomatic brain metastases are eligible provided they meet defined criteria.
    • Adequate organ function as defined in protocol.

    Exclusion Criteria:

    • History of other malignancy within the past 2 years with exceptions.
    • Major surgery within 28 days of study day 1.
    • Untreated or symptomatic brain metastases and leptomeningeal disease.
    • Participants who experienced recurrent grade 2 pneumonitis or severe or life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.
    • History of immune-related colitis.
    • History or evidence of interstitial lung disease or active, non-infectious pneumonitis.
    • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
    • Participants with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment
    • Participant has known active infection requiring parenteral antibiotic treatment. Upon completion of parenteral antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint
    • NOTE: Simple urinary tract infections and uncomplicated bacterial pharyngitis are permitted if responding to an active treatment and after consultation with Medical Monitor. Participants requiring oral antibiotics who have been afebrile for >24 hours, have no leukocytosis, nor clinical signs of infection are eligible. Screening for chronic infectious conditions is not required.
    • History of hypophysitis or pituitary dysfunction.
    • History of solid organ transplantation or allogeneic hematopoietic stem cell transplantation.
    • Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. Participants with Type I diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are 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.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 2 Study of ALX148 in Combination with Pembrolizumab in Patients with Advanced Head and Neck Squamous Cell Carcinoma. - NCT04675294

    Primary Objective; To assess the effect of ALX148 plus pembrolizumab on 12-month overall survival (OS) rate and objective response rate (ORR) in patients with metastatic or with unresectable, recurrent HNSCC that is PD-L1 positive (CPS ≥1) and who have not yet been treated for their advanced disease. Secondary Objectives: 1. To assess secondary measures of efficacy for ALX148 administered in combination with pembrolizumab and for pembrolizumab alone. 2. To assess the safety and tolerability of ALX148 administered in combination with pembrolizumab and for pembrolizumab alone (including for patients in the safety lead-in cohort). Exploratory Objective: To explore the pharmacodynamic effect of ALX148 administered in combination with pembrolizumab and pembrolizumab alone in patients.

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    • Protocol Number:
      032208

    • Principal Investigator:
      Anupama Nehra M.D.

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Lung

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

    • Drugs Involved:
      ALX148 Pembrolizumab (MK-3475)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Anupama Nehra M.D.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) that is PD-L1 positive (CPS > 1) and who have not received prior systemic therapy for their advanced disease.
    • Adequate bone marrow function.
    • Adequate renal and liver function.
    • Adequate ECOG performance status.

    Exclusion Criteria:

    • Patients with known symptomatic CNS metastases or leptomeningeal disease requiring steroids.
    • History of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
    • Prior treatment with any anti-CD47 or anti-SIRPα agent.
    • Prior treatment with anti-PD-1 or PD-L1.

    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.

  • A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients with Advanced or Metastatic Solid Tumors including EGFR-mutated Non-Small Cell Lung Cancer. - NCT05498428

    Primary Objective: To assess the anti-tumor activity of amivantamab SC-CF (Cohorts 1, 2, and 3) in combination treatment.. Secondary Objectives: - To characterize the safety of amivantamab SC-CF (Cohorts 1, 2, and 3). - To assess additional measures of anti-tumor activity of amivantamab SC-CF (Cohorts 1, 2, and 3). - To assess amivantamab PK (Cohorts 1, 2, and 3). Exploratory Objectives: - To assess the relationship between PK or immunogenicity and selected endpoints including but not limited to efficacy and safety. - To assess the immunogenicity to rHuPH20 in participants treated with amivantamab SC-CF (Cohorts 1, 2, and 3).

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    • Protocol Number:
      032212

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Lung

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

    • Drugs Involved:
      PEMETREXED Amivantamab CARBOPLATIN Lazertinib

      • Contacts:

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

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-small cell lung cancer (NSCLC) that is not amenable to curative therapy including surgical resection or chemoradiation. Additional Cohort specific disease requirements include: Cohorts 1, 3, 3b, 5, 6 and 7: epidermal growth factor receptor (EGFR) exon 19 deletion (Exon19del) or Exon 21 L858R mutation; Cohort 2: EGFR Exon 20ins mutation. Cohorts 1,5,and6: Participant should not have received any prior systemic therapy for locally advanced or metastatic NSCLC. Cohort 2: Participant should not have received any prior systemic therapy for locally advanced or metastatic NSCLC. Cohorts 3and3b: Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment. Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second-line setting after prior treatment with first- or second-generation EGFR tyrosine kinase inhibitor (TKI) as a monotherapy. Cohort 4: Participants need to currently be on an amivantamab IV Q2W regimen (1,050 mg or 1,400 mg depending on weight) for at least 8 weeks, as part of standard of care, an expanded access program, or as a rollover from a long-term extension, without any amivantamab dose reduction. Cohort 7: Participants must have progressed on or after the combination of amivantamab and lazertinib as the most recent line of treatment. The combination of amivantamab and lazertinib must have been administered as the first-line treatment for locally advanced or metastatic disease. Cohort 2, 3, 3b, and 7 only: Squamous NSCLC are excluded. EGFR mutation must have been identified as determined by Food and Drug Administration (FDA) approved or other validated test of either circulating tumor deoxyribonucleic acid (ctDNA) or tumor tissue in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United states [US]) or an accredited local laboratory (sites outside of the US). A copy of the initial test report documenting the EGFR mutation must be included in the participant records and a deidentified copy must also be submitted to the sponsor
    • All cohorts except Cohort 4: Participants must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. If the only target lesion has been previously irradiated, it must show signs of disease progression since radiation was completed If only 1 non-irradiated measurable lesion exists, which undergoes a biopsy and is acceptable as a target lesion, the baseline tumor assessment scans should be performed at least 14 days after the biopsy
    • May have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
    • Have adequate organ (renal, hepatic, hematological, coagulation and cardiac) functions
    • Participant must have eastern cooperative oncology group (ECOG) status of 0 or 1
    • Cohort 6: Must be eligible for, and agree to comply with, the use of prophylactic anticoagulation with a direct oral anticoagulant or a low molecular weight heparin during the first 4 months of study treatment
    • A participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 6 months after receiving the last dose of study treatment. Female participants should consider preservation of eggs prior to study treatment as anti-cancer treatments may impair fertility

    Exclusion Criteria:

    • Participant has a medical history of interstitial lung disease (ILD), including drug induced ILD or radiation pneumonitis
    • Participant has a history of hypersensitivity to any excipients of the investigational products to be used in their enrollment cohort
    • Participant has received a live or live attenuated vaccine within 3 months before Cycle 1 Day 1. The seasonal influenza vaccine and non-live vaccines against Coronavirus disease 19 (COVID-19) are not exclusionary
    • For all cohorts (with regimens potentially including lazertinib): Participant is currently receiving medications or herbal supplements known to be potent Cytochrome (CYP3A4/5) inducers and is unable to stop use for an appropriate washout period prior to Cycle 1 Day 1
    • Other clinically active liver disease of infectious origin
    • Participant has a history of clinically significant cardiovascular disease including, but not limited to: a) All cohorts: diagnosis of deep vein thrombosis or pulmonary embolism within 1 month prior to the first dose of study treatment(s), or any of the following within 6 months prior to the first dose of study treatment(s): myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary/peripheral artery bypass graft, or any acute coronary syndrome. Clinically non-significant thrombosis, such as non-obstructive catheter-associated clots, are not exclusionary; b) All cohorts (with regimens potentially including lazertinib): Participant has a significant genetic predisposition to venous thromboembolic events (VTE; such as Factor V Leiden); c) All cohorts (with regimens potentially including lazertinib): Participant has a prior history of VTE and is not on appropriate therapeutic anticoagulation as per NCCN or local guidelines; d) prolonged corrected QT interval by Fridericia (QTcF) interval greater than (>) 480 milliseconds (msec) or clinically significant cardiac arrhythmia or electrophysiologic disease (example, placement of implantable cardioverter defibrillator or atrial fibrillation with uncontrolled rate); e) uncontrolled (persistent) hypertension: systolic blood pressure >160 millimeter(s) of mercury (mmHg); diastolic blood pressure >100 mmHg; f) Congestive heart failure defined as NYHA class III-IV or hospitalization for congestive heart failure (CHF) (any New York Heart Association [NYHA] class) within 6 months of treatment initiation at Cycle 1/day 1 (C1D1); g) pericarditis/clinically significant pericardial effusion; h) myocarditis; i) baseline left ventricular ejection fraction (LVEF) below the institution's lower limit of normal at screening, as assessed by echocardiogram or multigated acquisition (MUGA) scan
    • Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study. Participants who have received definitive radiation or surgical treatment for symptomatic or unstable brain metastases and have been clinically stable and asymptomatic for at least 2 weeks before Screening are eligible, provided they have been either off corticosteroid treatment or are receiving low-dose corticosteroid treatment (less than or equal to [<=] 10 milligrams per day [mg/day] prednisone or equivalent) for at least 2 weeks prior to treatment allocation

    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
    • Monmouth Medical Center Southern Campus
    • Community Medical Center
    • Newark Beth Israel Medical Center
    • Jersey City Medical Center
    • Rutgers Cancer Institute of New Jersey
  • A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients with Osteosarcoma. - NCT05235165

    Primary Objective: To determine if open surgical resection is superior to thoracoscopic resection for thoracic event-free survival (tEFS) in patients with resectable oligometastatic pulmonary osteosarcoma. Secondary Objectives: - To determine if open surgical resection is superior to thoracoscopy for event free survival (EFS) in patients with resectable oligometastatic pulmonary osteosarcoma. - To determine if open surgical resection is superior to thoracoscopy for overall survival (OS) in patients with resectable oligometastatic pulmonary osteosarcoma. - To determine if thoracoscopy is superior to open surgical resection for post-operative pain interference in patients with resectable oligometastatic pulmonary osteosarcoma.

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    • Protocol Number:
      112201

    • Principal Investigator:
      Scott Moerdler M.D.

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Bones and Joints,Lung

    • Therapies Involved:
      Surgery

      • Contacts:

      • Rutgers University Prinicipal Investigator: Scott Moerdler M.D.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Patients must be < 50 years at the time of enrollment.
    • Patients must have =< 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being >= 3 mm and all of which must be =< 3 cm size.
    • Note: Patient must have eligibility confirmed by rapid central imaging review.
    • Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon.
    • Patients must have a histological diagnosis of osteosarcoma.
    • Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease.
    • Patients with newly diagnosed disease must have completed successful gross tumor resection for their primary tumor or surgical local control of primary tumor must be planned to be performed simultaneously with thoracic surgery.
    • Newly diagnosed patients must be receiving or recently completed (within 60 days) systemic therapy considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.
    • Patients at time of 1st recurrence must have completed systemic therapy for their initial primary tumor, considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.

    Exclusion Criteria:

    • Patients with unresectable primary tumor.
    • Patients with pulmonary metastatic lesions that would require anatomic resection (lobectomy or pneumonectomy) or lesions that are defined as "central" (i.e., central lesion involves or is proximal to segmental bronchi and peripheral is lesion distal to segmental bronchi).
    • Patients with chest wall or mediastinal based metastatic lesions, or with significant pleural effusion.
    • Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy. Note: Once the patient has been enrolled on the study, additional computed tomography (CT) scans are not anticipated prior to thoracic surgery. Note: Some variation in nodule size measurements over the course of pre-operative therapy is anticipated and does not qualify for exclusion unless deemed true disease progression by the primary treatment team.
    • Patients with evidence of extrapulmonary metastatic disease.
    • Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment.
    • All patients and/or their parents or legal guardians must sign a written informed consent.
    • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.

    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.

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    • 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 (MK-3475) pembrolizumab/placebo

      • 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). Note: Note: Participants with histology showing a mixed tumor with small cell and non-small cell elements are not eligible. 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. 14. Abstains from breastfeeding during the study intervention period and for at least the following period after the last study intervention:
    • Pembrolizumab: 120 days
    • Olaparib: 7 days

    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 I Trial of T Cell Receptor Gene Therapy Targeting KK-LC-1 for Cancers of the Stomach, Breast, Lung and Cervix. - NCT05483491

    To determine the maximally tolerated dose of KK-LC-1 TCR T cells plus aldesleukin for the treatment of metastatic KK-LC-1 positive epithelial cancers.

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    • Protocol Number:
      192004

    • Principal Investigator:
      Christian Hinrichs

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site,Stomach,Breast,Lung,Cervix

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      FLUDARABINE CYCLOPHOSPHAMIDE KK-LC-1 TCR Interleukin-2 (Aldesleukin)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Christian Hinrichs

    Read Inclusion & Exclusion Criteria

    1. Signed, written informed consent obtained prior to any study procedures. 2. Age > 18 years at the time of informed consent. 3. Metastatic solid tumor with ≥ 25% of tumor cells positive for KK-LC-1 by IHC assay. Due to the low frequency of KK-LC-1 expression in most cancers, screening will focus on gastric, NSCLC, TNBC, and cervix cancers. The IHC test will be performed by the Rutgers Cancer Institute of New Jersey, Department of Biorepository Services. 4. HLA-A*01:01 allele by HLA haplotype test. 5. Measureable disease per RECIST Criteria Version 1.1 at time of enrollment. 6. Prior treatment with cancer type-specific stand of care systemic cancer therapy is required. Standard treatment options must be considered and declined. Documentation of rationale is required if a subject is deemed unsuitable for standard therapy. 7. Subjects with < 3 brain metastases that have been treated with surgery or stereotactic radiosurgery are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month before protocol treatment. Patients with surgically resected brain metastases are eligible. 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening. 9. Negative pregnancy test for women under 55 and all women who have had a menstrual period in the last 12 months. A pregnancy tests is not required for women who have had a bilateral oophorectomy or hysterectomy. 10. Women of child-bearing potential must agree to use adequate contraception (i.e., intrauterine device, hormonal barrier method of birth control; abstinence; tubal ligation or vasectomy) prior to study entry and for four months after treatment. Should a women become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. 11. Participants must have organ and marrow function as defined below: 1. Leukocytes > 3,000/mcL 2. Absolute neutrophil count > 1,500/mcL 3. Platelets > 100,000/mcL 4. Hemoglobin > 9.0 g/dL 5. Total bilirubin within normal institutional limits except in participants with Gilbert's Syndrome who must have a total bilirubin < 3.0 mg/dL. 6. Serum AST (SGOT)/ALT (SGPT) < 2.5 x ULN 7. Calculated creatinine clearance (CrCl) >50 mL/min/1.73 m2for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation). 8. INR or a PTT ≤1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must have a PT or PTT within therapeutic range and no history of severe hemorrhage. 12. Serology:
    • HIV antibody negative
    • Hepatitis B antigen negative
    • Hepatitis C antibody negative or HCV RNC negative (i.e., no current HCV infection) 13. More than four weeks must have elapsed since any prior systemic therapy or radiotherapy at the time the patient receives the KK-LC-1 TCR T cells. Adverse events from prior therapy must have resolved to≤ grade 1 according to CTCAE Version 5 or have demonstrated clinical stability and meet the eligibility criteria for the protocol. 14. Oxygen saturation ≥ 92% on room air. 15. Left ventricular ejection fraction ≥45% by echocardiogram or MUGA for patients 50 years of age or older.

    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 I/II Study of TheraT? Vector(s) Expressing Human Papillomavirus 16 Positive (HPV 16+) Specific Antigens in Patients with HPV 16+ Confirmed Cancers. - NCT04180215

    Primary Objective: To determine the RP2D in terms of safety and tolerability for: a. IV administration of HB-201 in patients with HPV 16+ confirmed HNSCC b. IT administration of HB-201 in patients with HPV 16+ confirmed cancers c. IV administration of HB-202 in patients with HPV 16+ confirmed HNSCC d. IV administration of HB-202 in patients with HPV 16+ confirmed cancers

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    • Protocol Number:
      032213

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Lung

    • Therapies Involved:
      Immunotherapy

    • Drugs Involved:
      HB-201 HB-202

      • Contacts:

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

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria

      All Patients:
    • Documentation of confirmed HPV 16+ cancer via genotype testing.
    • ≥ 1 measurable lesion by imaging for tumor response following RECIST
    • ECOG performance status of 0 to 1.
    • Prior curative radiation therapy and prior focal palliative completed per protocol-specified wash-out windows.
    • Screening laboratory values must meet protocol-specified criteria.
    • Able to provide tumor tissue following last treatment, unless otherwise agreed. Treatment Group E or Group F:
    • Documentation of confirmed head and neck squamous cell carcinoma.
    • Eligible to receive pembrolizumab, per standard of care and product label.
    • Group E: this group includes first line / 1L patients who have not yet received treatment in the metastatic/recurrent setting.
    • Group F: Tumor progression or recurrence on standard of care therapy, including ≥1 systemic therapy. Imaging Sub-Study (for specific participants at Memorial Sloan Kettering Cancer Center only):
    • Meeting requirements of inclusion criteria for Treatment Group 1 or Group 3.
    • At least 1 non-irradiated measurable lesion documented through imaging.

    Exclusion Criteria:

      All patients:
    • Metastatic central nervous system disease, and/or carcinomatous meningitis.
    • Any serious or uncontrolled medical disorder that, in the opinion of the Investigator, may increase the risk associated with study participation / treatment administration.
    • Concurrent malignancy that is clinically significant or requires active intervention, unless protocol-defined criteria are met.
    • Active, known or suspected, autoimmune or inflammatory disorders requiring immunosuppressive therapy.
    • Has a life expectancy of less than 3 months.
    • Any toxicities attributed to systemic prior anticancer therapy o that have not resolved to Grade 1 or baseline prior to the first administration of study drug, unless protocol-defined criteria is met.
    • Not meeting the protocol-specified washout periods for prohibited medications.
    • Prior anaphylactic reaction to or known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s).
    • Positive hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, indicating acute or chronic infection.
    • Known history of acquired immunodeficiency syndrome. For patients in Groups E or F and certain backfill cohorts:
    • History of severe hypersensitivity reaction to or other contraindication to receiving pembrolizumab.
    • History of/Presently having non-infectious pneumonitis requiring treatment.
    • Was discontinued due to a Grade 3 or higher immune-related AE (irAE) after receiving prior therapy with check point inhibitors. Imaging Sub-Study (for specific participants at Memorial Sloan Kettering Cancer Center only):
    • Having splenic disorders or prior splenectomy, and can compromise protocol objectives per Investigator and/or Sponsor.
    • Meeting requirements of exclusion criteria for Treatment Group 3

    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 III, Randomised, Open-Label Study of Savolitinib in Combination With Osimertinib Versus Platinum-Based Doublet Chemotherapy in Participants With EGFR Mutated MET-Overexpressed and/or Amplified, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed on Treatment With Osimertinib. - NCT05261399

    Primary Objective: To determine the efficacy of savolitinib in combination with osimertinib versus platinum doublet chemotherapy by assessment of PFS in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib. Secondary Objectives: - To determine the efficacy of savolitinib in combination with osimertinib versus platinum doublet chemotherapy by assessment of OS in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib. - To determine the efficacy of savolitinib in combination with osimertinib versus platinum doublet chemotherapy by assessment of PFS in participants with EGFR mutated, MET-overexpressed by IHC, locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib. - To determine the efficacy of savolitinib in combination with osimertinib versus platinum doublet chemotherapy by assessment of OS in participants with EGFR mutated, MET-overexpressed by IHC, locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib. - To determine the efficacy of savolitinib in combination with osimertinib versus platinum doublet chemotherapy by assessment of ORR, DoR, DCR, TDT or death, and tumour shrinkage in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib. - To assess participant-reported pulmonary core symptoms of NSCLC in participants treated with savolitinib in combination with osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib. - To evaluate the PK of savolitinib.

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    • Protocol Number:
      032207

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Lung

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Savolitinib PEMETREXED CARBOPLATIN Osimertinib

      • Contacts:

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

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Provision of signed and dated written ICF prior to any mandatory and non-mandatory study-specific procedures, sampling and analyses.
    • Participant must be ≥18 years (≥ 20 years of age in Japan) at the time of signing the informed consent. All genders are permitted.
    • Histologically or cytologically confirmed locally advanced or metastatic NSCLC which is not amenable to curative therapy.
    • Must have at least one documented sensitising EGFR mutation: exon19 deletion, L858R mutation, and/or T790M.
    • Documented radiologic progression on first- or second-line treatment with osimertinib as the most recent anti-cancer therapy.
    • Mandatory provision of FFPE tumour tissue.
    • MET overexpression and/or amplification in tumour specimen collected following progression on prior osimertinib treatment.
    • Measurable disease as defined by RECIST 1.1.
    • Adequate haematological, liver, renal and cardiac functions, and coagulation parameters.
    • ECOG performance status of 0 or 1.

    Exclusion Criteria:

    • Predominant squamous NSCLC, and small cell lung cancer.
    • Prior or current treatment with a third-generation EGFR-TKI other than Osimertinib.
    • Prior or current treatment with savolitinib or another MET inhibitors.
    • Spinal cord compression or brain metastases, unless asymptomatic and are stable.
    • History or active leptomeningeal carcinomatosis.
    • Unresolved toxicities from any prior therapy greater than CTCAE Grade 1 with the exception of alopecia, haemoglobin ≥ 9.0 g/dL, and Grade 2 prior platinum-therapy related neuropathy.
    • Active/unstable cardiac diseases currently or within the last 6 months, clinically significant ECG abnormalities, and/or factors/medications that may affect QTc intervals.
    • History of liver cirrhosis of any origin and clinical stage; or history of other serious liver disease or chronic disease with relevant liver involvement.
    • Known serious active infection including, but not limited to, tuberculosis, or HIV, HBV or HCV or gastrointestinal disease.
    • Receipt of live attenuated vaccine (including against COVID-19) within 30 days prior to the first dose of study intervention.
    • Past medical history of ILD, drug-induced ILD, radiation pneumonitis, which required steroid treatment, or any evidence of clinically active ILD.
    • Participants currently receiving medications or herbal supplements known to be strong inducers of cytochrome P450 (CYP)3A4 or strong inhibitors of CYP1A2.

    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.

    • Newark Beth Israel Medical Center
    • Rutgers Cancer Institute of New Jersey
  • A Prospective Randomized Study of Ramucirumab plus Pembrolizumab versus Standard of Care for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer. - NCT05633602

    Primary Objective: To compare overall survival (OS) in participants previously treated with platinum-based chemotherapy and immunotherapy for Stage IV or recurrent non-small cell lung cancer (NSCLC) randomized to pembrolizumab and ramucirumab versus standard of care. Secondary Objective: To summarize reports of serious and unexpected high-grade (≥ Grade 3) treatment-related adverse events determined by the treating physician within each treatment arm.

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    • Protocol Number:
      032304

    • Phase:
      Phase II/III

    • Scope:
      Local

    • Applicable Disease Sites:
      Lung

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Pembrolizumab (MK-3475) Ramucirumab

      • Contacts:

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

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Participants must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) which is stage IV or recurrent
    • Participants must have received at least one line of anti-PD-1 or anti-PD-L1 therapy for any stage of NSCLC. Anti-PD-1 or anti-PD-L1 may have been given alone or in combination with other therapy
    • Participants must have experienced disease progression (in the opinion of the treating physician) more than (>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or PD-L1 therapy
    • Participants who received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease, must have had a best response on anti-PD-1 or anti-PD-L1 therapy of stable, partial response or complete response (in the opinion of the treating physician)
    • Participants who received neoadjuvant, adjuvant, and/or consolidation anti-PD-1 or anti-PD-L1 therapy as their only line of anti-PD-1 or anti-PD-L1 therapy must have experienced disease progression within (=<) 365 days from initiation (cycle 1 day 1) of anti-PD-1 or PD-L1 therapy
    • Participants must have received platinum-based chemotherapy and experienced disease progression (in the opinion of the treating physician) during or after this regimen
    • Participants with a known sensitizing mutation for which an Food and Drug Administration (FDA)-approved targeted therapy for NSCLC exists (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, KRAS, HER2 and MET sensitizing mutations), must have previously received at least one of the approved therapy(s). Prior targeted therapy for participants with targetable alterations is allowed if all other eligibility criteria are also met
    • Participants must be >= 18 years old
    • Participants must be able to safely receive the investigational drug combination and the investigator's choice of standard of care regimens per the current FDA approved package insert(s), treating investigator's discretion, and institutional guidelines
    • Participants must have Zubrod performance status of 0-2

    Exclusion Criteria:

    • Participants must not have received more than one line of anti-PD-1 or anti-PD-L1 for stage IV or recurrent disease
    • Participants must not be receiving or planning to receive another investigational therapy during study participation

    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
    • Monmouth Medical Center Southern Campus
    • Community Medical Center
    • Newark Beth Israel Medical Center
    • RWJ University Hospital Hamilton
    • 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. - 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.

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    • 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. NOTE: Initial informed consent will remain valid throughout the 12-week period between surgical resection and study registration unless, in the opinion of the treating investigator, the participant experiences a significant change in medical or mental status.
    • 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. NOTE: According to AJCC 8th edition, subjects with lepidic predominant adenocarcinoma should be staged based on their invasive tumor size and not their total tumor size (i.e., subjects with lepidic predominant tumors whose invasive tumor size is less than 1 cm are not eligible, even if their total tumor size is 1.0 cm or greater).
    • 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 5 x 5µm unstained 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 active 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 or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is 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/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). 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.

    • Monmouth Medical Center
    • Community Medical Center
    • Rutgers Cancer Institute of New Jersey
  • A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-Naive Subjects with Advanced or Metastatic PD-L1 High [TPS>50%J Non-Small Cell Lung Cancer without Actionable Genomic Alterations (Tropion-Lung08) - Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-Line Treatment of Subjects with Advanced or Metastatic NSCLC without Actionable Genomic Alterations. - NCT05215340

    Primary Objectives: - To compare the efficacy of Dato-DXd in combination with pembrolizumab versus pembrolizumab alone, as measured by progression-free survival (PFS) by blinded independent central review (BICR)- To compare the efficacy of Dato-DXd in combination with pembrolizumab versus pembrolizumab alone, as measured by overall survival (OS) Key Secondary Objectives: - To evaluate the efficacy of Dato-DXd in combination with pembrolizumab versus pembrolizumab alone, as measured by objective response rate (ORR) by BICR Secondary Objectives: - To further evaluate the efficacy of Dato- DXd in combination with pembrolizumab versus pembrolizumab alone - To evaluate the patient-reported outcomes (PROs) of Dato-DXd in combination with pembrolizumab and of pembrolizumab alone - To further evaluate the safety of Dato- DXd in combination with pembrolizumab - To assess the immunogenicity of Dato-DXd in the investigational treatment arm Exploratory Objectives: - To evaluate exposure-response relationships of Dato- DXd for efficacy and safety endpoints - To evaluate biomarkers that may be correlated with the clinical benefit from Dato-DXd in combination with pembrolizumab versus pembrolizumab monotherapy - To evaluate biomarkers that may be correlated with adverse effects from Dato-DXd in combination with pembrolizumab versus pembrolizumab monotherapy - To explore how changes in biomarkers may relate to exposure, AEs, and clinical outcomes - To evaluate PRO endpoints for Dato-DXd in combination with pembrolizumab versus pembrolizumab alone

    View All Details
    • Protocol Number:
      032211

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Lung

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

    • Drugs Involved:
      Dato-DXd Pembrolizumab (MK-3475)

      • Contacts:

      • RWJBarnabas Health - Cooperman Barnabas, Livingston Prinicipal Investigator: Andrew Brown MD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      Participants eligible for inclusion in the study must meet all inclusion criteria within 28 days of randomization into the study.
    • Sign and date the Tissue Screening and Main Informed Consent Forms, prior to the start of any study-specific qualification procedures.
    • Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time of informed consent.
    • Histologically documented NSCLC that meets all of the following criteria: 1. Stage IIIB or IIIC disease and not candidates for surgical resection or definitive chemoradiation, or Stage IV NSCLC disease at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition). Participants with early-stage NSCLC who have relapsed should be restaged during screening to ensure their eligibility for the study. 2. Documented negative test results for epidermal growth factor receptor (EGFR), lymphoma kinase (ALK), and proto-oncogene1 (ROS1) actionable genomic alterations based on analysis of tumor tissue. 3. No known actionable genomic alterations in neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), rearranged during transfection (RET), mesenchymal-epithelial transition factor (MET), or other actionable driver kinases with locally approved therapies.
    • Has provided a formalin-fixed tumor tissue sample for the measurement of trophoblast cell surface protein 2 (TROP2) protein expression and for the assessment of other exploratory biomarkers.
    • Tumor has high programmed death receptor-1 (PD-L1) expression (TPS ≥50%) as determined by PD-L1 immunohistochemistry (IHC) 22C3 pharmDx assay by central testing (minimum of 6 slides).
    • Has an adequate treatment washout period before Cycle 1 Day 1.
    • Measurable disease based on local imaging assessment using RECIST Version 1.1.
    • Has left ventricular ejection fraction (LVEF) ≥50% by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before randomization.
    • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at screening.
    • Has a life expectancy of at least 3 months.
    • Adequate bone marrow function within 7 days before randomization.

    Exclusion Criteria:

    • Has received prior systemic treatment for advanced or metastatic NSCLC.
    • Has received prior treatment for NSCLC with any of the following, including in the adjuvanteoadjuvant setting: 1. Any agent, including an antibody-drug conjugate, containing a chemotherapeutic agent targeting topoisomerase I. 2. TROP2-targeted therapy. 3. Any anti-programmed death receptor-1 (PD-1), anti-PD-L1, or anti-PD-ligand 2 (L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137). 4. Any other immune checkpoint inhibitors. Participants who received adjuvant or neoadjuvant therapy OTHER than those listed above, are eligible if the adjuvanteoadjuvant therapy was completed at least 6 months prior to the diagnosis of advanced/metastatic disease.
    • Has spinal cord compression or active and untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable.
    • Has received prior radiotherapy ≤4 weeks of start of study intervention or more than 30 Gy (unit of ionizing radiation dose in the International System of Units) to the lung within 6 months of Cycle 1 Day 1.
    • History of another primary malignancy (beyond NSCLC) except for: 1. Malignancy treated with curative intent and with no known active disease ≥3 years before the first dose of study treatment and of low potential risk for recurrence. 2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. 3. Adequately treated carcinoma in situ without evidence of disease. 4. Participants with a history of prostate cancer (tumorode/metastasis stage) of Stage ≤T2cN0M0 without biochemical recurrence or progression and who in the opinion of the Investigator are not deemed to require active intervention.
    • Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis including radiation pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
    • Clinically severe pulmonary compromise, as judged by the investigator, resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement or prior complete pneumonectomy.
    • Uncontrolled or significant cardiovascular disease, including: 1. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) interval >470 msec regardless of sex (based on the average of the 12-lead electrocardiogram determination at screening). 2. Myocardial infarction within 6 months prior to randomization. 3. Uncontrolled angina pectoris within 6 months prior to randomization. 4. LVEF <50% by ECHO or MUGA scan within 28 days before randomization. 5. New York Heart Association Class 2 to 4 congestive heart failure (CHF) at screening. 6. Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) within 28 days before randomization. Participants with a history of Class 2 to 4 CHF prior to screening, must have returned to Class 1 CHF and have LVEF ≥50% (by either an ECHO or MUGA scan within 28 days before randomization) in order to be eligible.
    • Clinically significant corneal disease.
    • Has received a live vaccine or live-attenuated vaccine (messenger ribonucleic acid and replication-incompetent adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of study drug. For any participant receiving an approved severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine, please follow the vaccine label and/or local guidance.
    • Active, known, or suspected autoimmune disease (has an active autoimmune disease that has required systemic treatment in the past 2 years).
    • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosage >10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy ≤7 days prior to the first dose of study drug.
    • Has known human immunodeficiency virus (HIV) infection that is not well controlled.
    • Has an active hepatitis or uncontrolled hepatitis B or active hepatitis C infection.
    • Has an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
    • Had an allogeneic tissue/solid organ transplant.
    • Has a history of severe hypersensitivity reactions to either the drug or inactive ingredients (including but not limited to polysorbate 80) of Dato-DXd or pembrolizumab.

    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
    • Monmouth Medical Center Southern Campus
    • Community Medical Center
    • Rutgers Cancer Institute of New Jersey
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