At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 541 enrolled
Drug / intervention
Nivolumab +5 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.
An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer
In Brief
A Phase 3 clinical trial evaluating Nivolumab, Gemcitabine, and 4 other interventions for Stage IV or Recurrent Non-Small Cell Lung Cancer. Completed, enrolled 541 participants across 141 sites in 26 countries.
Detailed Summary
The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Finland, France, Germany, Greece, Hungary, Italy, Japan, Mexico, Netherlands, Poland, Romania, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
CollaboratorsOno Pharmaceutical Co., Ltd.
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 2014
Enrollment StartMar 2014
Primary CompletionJul 2016
Study CompletionMay 2022
TodayJul 2026
First PostedJan 22, 2014
Enrollment StartMar 27, 2014
Primary CompletionJul 1, 2016
Study CompletionMay 27, 2022
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.4 years ago
Interventions
Nivolumabbiological
Gemcitabinedrug
Cisplatindrug
Carboplatindrug
Paclitaxeldrug
Pemetrexeddrug