At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 324 enrolled
Drug / intervention
Nivolumab +2 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.
A Study of Nivolumab in Combination With Ipilimumab (Part 1); and Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC)
In Brief
A Phase 2 clinical trial evaluating Nivolumab, Ipilimumab, and 1 other intervention for Non-Small-Cell Lung Cancer. Completed, enrolled 324 participants across 32 sites in 2 countries.
Detailed Summary
The purpose of part 1 of this study is to determine the objective response rate (ORR) in stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line therapy. The purpose of part 2 of this study is to determine the safety and tolerability of nivolumab and ipilimumab combined with a short course of chemotherapy in first line stage IV NSCLC.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small-Cell Lung Cancer
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 2016
Enrollment StartFeb 2016
Primary CompletionJun 2018
Study CompletionMar 2022
TodayJul 2026
First PostedJan 20, 2016
Enrollment StartFeb 15, 2016
Primary CompletionJun 22, 2018
Study CompletionMar 7, 2022
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 10.5 years ago
Interventions
Nivolumabbiological
Specified Dose on Specified Days
Ipilimumabbiological
Specified Dose on Specified Days
Platinum Doublet Chemotherapydrug