Print

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. The first primary completion date of Pathological Complete Response is anticipated to be reached April 2020. The completion date for all primary outcome measures is expected May 2023.

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 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

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536
Contact:
John Villano, Site 0170
859-218-6145

More Details

NCT ID
NCT02998528
Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Clinical.Trials@bms.com

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.