A Phase 3, Randomized, Double-blind Study of Neoadjuvant Chemotherapy plus Nivolumab versus Neoadjuvant Chemotherapy plus Placebo, followed by Surgical Resection and Adjuvant Treatment with Nivolumab or Placebo for Participants with Resectable Stage II-IIIB Non-small Cell Lung Cancer
The main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant) immunotherapy will prolong event free survival in participants with early stage non-small cell lung cancer.
Primary Objective: To compare the event-free survival (EFS) by blinded
independent central review (BICR) in Arm A vs Arm B participants
Secondary Objectives: To compare the overall survival (OS) in Arm A vs Arm
To assess the pathologic complete response (pCR) rate by BIPR in Arm A vs Arm B participants
To assess the major pathological response (MPR) rate
by BIPR in Arm A vs Arm B participants
Exploratory Objectives: To assess objective response rate (ORR) by BICR in
Arm A vs Arm B participants
To assess time to death or distant metastasis (TTDM) by BICR in Arm A vs Arm B participants
To assess the feasibility of surgery and rate of peri- and post-operative complications (within 90 days of surgery) in Arm A vs Arm B participants
To assess safety and tolerability in Arm A vs Arm B participants
To assess changes in disease-related symptoms and impacts on health-related quality of life in Arm A vs Arm B participants
To assess changes in health status and health-related quality of life
To assess changes in physical function
To characterize participant perceptions of the bothersomeness of symptomatic AEs
Assess the measurement properties of the NSCLC-SAQ
To characterize the immunogenic potential of nivolumab
To characterize PK of nivolumab
To evaluate the efficacy after next line of treatment
To evaluate candidate predictive biomarkers including, but not limited to, biomarkers within the tumor (e.g. tumor inflammatory gene expression signatures, driver mutations, immune cell infiltrates, etc) as well as within
the periphery (eg, ctDNA, soluble inflammatory /immunosuppressive factors, as potential predictive biomarkers of efficacy)
Participants with suspected or histologically confirmed Stage IIA (> 4 cm) to IIIB (T3N2) non-small cell lung carcinoma (NSCLC) with disease that is considered resectable
No brain metastasis
Treatment-naive for NSCLC (no prior systemic anti-cancer treatment)
Ability to provide surgical or biopsy tumor tissue for biomarkers. All participants must have tissue submitted to a central laboratory during screening. Either FFPE (preferred) tissue block or 5-10 unstained tumor tissue slides, obtained
within 3 months prior to enrollment, with an associated pathology report, must be submitted to the central laboratory for inclusion. Biopsy should be excisional, core needle, or surgical specimen. Fine needle aspiration is unacceptable for submission. The central laboratory must provide IRT with PD-L1 status prior to randomization.
Eastern Cooperative Oncology Group (ECOG) Performance Status of > Other protocol-defined inclusion/exclusion criteria apply
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