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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

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 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
    Specified dose on specified days
  • Drug: Vinorelbine
    Specified dose on specified days
  • Drug: Gemcitabine
    Specified dose on specified days
  • Drug: Docetaxel
    Specified dose on specified days
  • Drug: Pemetrexed
    Specified dose on specified days
  • Drug: Carboplatin
    Specified dose on specified days
  • Drug: Paclitaxel
    Specified dose on specified days
Experimental
Nivolumab plus platinum doublet chemotherapy
Specified dose on specified days
  • Biological: Nivolumab
    Specified dose on specified days
    Other names:
    • BMS-936558
    • Opdivo
  • Drug: Cisplatin
    Specified dose on specified days
  • Drug: Gemcitabine
    Specified dose on specified days
  • Drug: Pemetrexed
    Specified dose on specified days
  • Drug: Carboplatin
    Specified dose on specified days
  • Drug: Paclitaxel
    Specified dose on specified days
Experimental
Nivolumab plus Ipilimumab
Specified dose on specified days
  • Biological: Nivolumab
    Specified dose on specified days
    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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.