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Trial ID CA209-816  |   NCT02998528

A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)

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Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC. This study has multiple primary endpoints.

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Key Eligibility Criteria

Inclusion Criteria: - Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue - Lung function capacity capable of tolerating the proposed lung surgery - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 - Available tissue of primary lung tumor Exclusion Criteria: - Presence of locally advanced, inoperable or metastatic disease - Participants with active, known or suspected autoimmune disease - Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors) Other protocol defined inclusion/exclusion criteria apply

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Nivolumab plus Ipilimumab

ASSIGNED INTERVENTION
  • Biological: Nivolumab, Ipilimumab

Study Arms

Experimental: Nivolumab plus platinum doublet chemotherapy

ASSIGNED INTERVENTION
  • Biological: Nivolumab
  • Drug: Cisplatin, Gemcitabine, Pemetrexed, Carboplatin, Paclitaxel

Study Arms

Active Comparator: Platinum doublet chemotherapy

ASSIGNED INTERVENTION
  • Drug: Cisplatin, Vinorelbine, Gemcitabine, Docetaxel, Pemetrexed, Carboplatin, Paclitaxel

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