A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor (TKI) Therapy
NCT02864251 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 367
Last updated 2023-09-28
Summary
The main purpose of this study is to determine whether nivolumab + chemotherapy is effective as compared to chemotherapy in the treatment of patients with EGFR mutation, NSCLC who failed first line (1L) or second-line (2L) EGFR TKI therapy.
Conditions
- Non-Small-Cell Lung Carcinoma
Interventions
- BIOLOGICAL
-
Specified dose on specified days
- BIOLOGICAL
-
Specified dose on specified days
- DRUG
-
Pemetrexed
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Specified dose on specified days
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
- 2017-03-17
- Primary Completion
- 2022-01-20
- Completion
- 2022-10-17
- FDA Drug
- Yes
Countries
- United States
- Canada
- China
- France
- Hong Kong
- Japan
- Singapore
- South Korea
- Spain
- Taiwan
Study Locations
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