A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Biological: Nivolumab
* Drug: Carboplatin
* Drug: Cisplatin
* Drug: Paclitaxel
* Drug: Pemetrexed
* Drug: Placebo
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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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 ≤ 1 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo<br> | Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: Opdivo, BMS936558;Drug: Carboplatin<br>* Specified dose on specified days<br>Drug: Cisplatin<br>* Specified dose on specified days<br>Drug: Paclitaxel<br>* Specified dose on specified days<br>Drug: Pemetrexed<br>* Specified dose on specified days<br>Drug: Docetaxel<br>* Specified dose on specified days<br>|
| Placebo Comparator: Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac.<br> | Drug: Carboplatin<br>* Specified dose on specified days<br>Drug: Cisplatin<br>* Specified dose on specified days<br>Drug: Paclitaxel<br>* Specified dose on specified days<br>Drug: Pemetrexed<br>* Specified dose on specified days<br>Drug: Placebo<br>* Specified dose on specified days<br>Drug: Docetaxel<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-Free Survival (EFS) as Assessed by Blinded Independent Central Review (BICR) |  | 5 Years from randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | Up to 5 years from randomization | 
| Pathologic Complete Response (pCR) Rate as Assessed by Blinded Independent Pathology Review (BIPR) |  | At the time of surgery, between week 12 to week 18 | 
| Major Pathological Response (MPR) Rate as Assessed by Blinded Independent Pathology Review |  | Up to 8 weeks following completion of neoadjuvant surgery, approximately study week 22 | 
| Incidence of Serious Adverse Events (SAEs) |  | Up to 80 weeks | 
| Incidence of Adverse Events (AEs) |  | Up to 80 weeks |