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Clinical Trial 20402

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT04025879

Phase: Phase III
Principal Investigator: Gray, Jhanelle

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Study Title

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 ()

Inclusion Criteria

  • 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
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of > Other protocol-defined inclusion/exclusion criteria apply

  • Exclusion Criteria

  • Participants with an active, known or suspected autoimmune disease
  • Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV)
  • Any previous anti-cancer treatment including cytotoxic, IO treatment, targeted agents, or radiotherapy for NSCLC
  • Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • Other protocol-defined inclusion/exclusion criteria apply

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