A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)
NCT02998528 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 505
Last updated 2026-01-06
Summary
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.
Conditions
- Non Small Cell Lung Cancer
Interventions
- BIOLOGICAL
-
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Pemetrexed
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- BIOLOGICAL
-
This arm is closed and no longer enrolling patients.
Sponsors & Collaborators
-
Ono Pharmaceutical Co. Ltd
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-03-04
- Primary Completion
- 2021-09-08
- Completion
- 2024-12-06
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Brazil
- Canada
- China
- France
- Greece
- Hungary
- Italy
- Japan
- Romania
- South Korea
- Spain
- Taiwan
- Turkey (Türkiye)
Study Locations
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