At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 367 enrolled
Drug / intervention
Nivolumab +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Nivolumab, Ipilimumab, and 3 other interventions for Non-Small-Cell Lung Carcinoma. Completed, enrolled 367 participants across 109 sites in 10 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small-Cell Lung Carcinoma
CountriesCanada, China, France, Hong Kong, Japan, Singapore, South Korea, Spain, Taiwan, United States
CollaboratorsOno Pharmaceutical Co., Ltd.
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 2016
Enrollment StartMar 2017
Primary CompletionJan 2022
Study CompletionOct 2022
TodayJul 2026
First PostedAug 11, 2016
Enrollment StartMar 17, 2017
Primary CompletionJan 20, 2022
Study CompletionOct 17, 2022
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 9.9 years ago
Interventions
Nivolumabbiological
Specified dose on specified days
Ipilimumabbiological
Specified dose on specified days
Pemetrexeddrug
Specified dose on specified days
Cisplatindrug
Specified dose on specified days
Carboplatindrug
Specified dose on specified days