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

Purpose

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.

Condition

  • Non Small Cell Lung Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 could apply

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Platinum doublet chemotherapy
Specified dose on specified days
  • Drug: Cisplatin
  • Drug: Vinorelbine
  • Drug: Gemcitabine
  • Drug: Docetaxel
  • Drug: Pemetrexed
  • Drug: Carboplatin
  • Drug: Paclitaxel
Experimental
Nivolumab plus platinum doublet chemotherapy
Specified dose on specified days
  • Biological: Nivolumab
    Other names:
    • BMS-936558
    • Opdivo
  • Drug: Cisplatin
  • Drug: Gemcitabine
  • Drug: Pemetrexed
  • Drug: Carboplatin
  • Drug: Paclitaxel
Experimental
Nivolumab plus Ipilimumab
Specified dose on specified days
  • Biological: Nivolumab
    Other names:
    • BMS-936558
    • Opdivo
  • Biological: Ipilimumab
    This arm is closed and no longer enrolling patients.
    Other names:
    • BMS-734016
    • Yervoy

Recruiting Locations

More Details

NCT ID
NCT02998528
Status
Active, not recruiting
Sponsor
Bristol-Myers Squibb