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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 B participants 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)
Alimta (Pemetrexed); BMS-936558 (Nivolumab); Nivolumab (Opdivo); Paraplatin (carboplatin); Pemetrexed (); Placebo (); Taxol (paclitaxel); Taxotere (docetaxel); carboplatin (); cisplatin (); docetaxel (); paclitaxel ()