A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC
NCT03215706 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 719
Last updated 2025-12-17
Summary
The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as the first treatment given for the disease
Conditions
Interventions
- BIOLOGICAL
-
Specified dose on specified day
- BIOLOGICAL
-
Specified dose on specified day
- DRUG
-
Specified dose on specified day
- DRUG
-
Specified dose on specified day
- DRUG
-
Pemetrexed
Specified dose on specified day
- DRUG
-
Specified dose on specified day
Sponsors & Collaborators
- 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
- 2017-08-24
- Primary Completion
- 2019-08-16
- Completion
- 2024-10-18
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Belgium
- Brazil
- Canada
- Chile
- China
- France
- Germany
- Ireland
- Italy
- Japan
- Mexico
- Poland
- Romania
- Russia
- Spain
- United Kingdom
Study Locations
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