A Randomized Phase 2 Platform Study to Evaluate Cemiplimab plus Chemotherapy vs. Cemiplimab plus Chemotherapy plus Other Cancer Treatments for the Perioperative treatment of Patients with Resectable Non-Small Cell Lung Cancer.
Primary:
To evaluate the anti-tumor activity of cemiplimab plus chemotherapy plus novel cancer treatments as compared to cemiplimab plus chemotherapy for the perioperative treatment of resectable NSCLC.
Secondary:
- To evaluate the safety profile of cemiplimab plus chemotherapy plus novel cancer treatments as compared to cemiplimab plus chemotherapy.
- To evaluate the feasibility of surgery in participants receiving cemiplimab plus chemotherapy plus novel cancer treatments as compared to cemiplimab plus chemotherapy.
- To evaluate the immunogenicity of cemiplimab and novel anticancer agents in the investigational arms, and to evaluate the immunogenicity of cemiplimab in the control arm.
- To evaluate the efficacy of cemiplimab plus chemotherapy plus novel cancer treatments as compared to cemiplimab plus chemotherapy.
REGN7075
- RWJBarnabas Health
- Community Medical Center
- Cooperman Barnabas, Livingston
- Jersey City Medical Center, Jersey City
- Monmouth Medical Center
- Monmouth Medical Center Southern Campus
- Rutgers University
General Key Inclusion Criteria: 1. Histologically confirmed stage II through IIIB (N2) NSCLC, that is considered resectable with curative intent, as described in the protocol 2. Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 3. Available formalin-fixed paraffin-embedded (FFPE) tumor sample blocks for submission, as described in the protocol 4. Eastern Cooperative Oncology Group Performance Status scale (ECOG PS) of 0 to 1 5. Adequate organ and bone marrow function, as described in the protocol General Key Exclusion Criteria: 1. Any systemic anti-cancer therapy or radiotherapy for the current tumor, as described in the protocol 2. Presence of known oncogenic alterations in epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) in the tumor prior to randomization, as described in the protocol 3. Presence of ≥ grade 2 peripheral neuropathy 4. Another malignancy that is progressing or requires active treatment, as described in the protocol Arm Specific Exclusion Criteria: Arm 1: 1. Grade ≥3 hypercalcemia, as defined in the protocol 2. Any central nervous system (CNS) pathology that could increase the risk of immune effector cell-associated neurotoxicity syndrome (ICANS), as described in the protocol 3. Has marked baseline prolongation of the time from the start of the Q wave to the end of the T wave in electrocardiogram(QT)/corrected QT interval (QTc) interval or risk factors for prolonged QTc, as described in the protocol Note: Other protocol-defined Inclusion/Exclusion criteria apply.
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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