Trials / Completed
CompletedNCT02864251
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
Open-Label, Randomized Trial of Nivolumab (BMS-936558) Plus Pemetrexed/Platinum or Nivolumab Plus Ipilimumab (BMS-734016) vs Pemetrexed Plus Platinum in Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) Subjects With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor Therapy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 367 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Nivolumab | Specified dose on specified days |
| BIOLOGICAL | Ipilimumab | Specified dose on specified days |
| DRUG | Pemetrexed | Specified dose on specified days |
| DRUG | Cisplatin | Specified dose on specified days |
| DRUG | Carboplatin | Specified dose on specified days |
Timeline
- Start date
- 2017-03-17
- Primary completion
- 2022-01-20
- Completion
- 2022-10-17
- First posted
- 2016-08-11
- Last updated
- 2023-09-28
- Results posted
- 2023-02-06
Locations
109 sites across 10 countries: United States, Canada, China, France, Hong Kong, Japan, Singapore, South Korea, Spain, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02864251. Inclusion in this directory is not an endorsement.