At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 363 enrolled
Drug / intervention
Nivolumabbiological
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 Dose Frequency Optimization, Phase IIIB/IV Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks
In Brief
A Phase 3 clinical trial evaluating Nivolumab for Lung Cancer. Completed, enrolled 363 participants across 129 sites in 8 countries.
Detailed Summary
The primary objective of this study is to compare PFS (progression-free survival) rate at 6 months and at 1 year after randomization, of Nivolumab 480 mg every 4 weeks with nivolumab 240 mg every 2 weeks in subjects with advanced/metastatic (Stage IIIb/IV) NSCLC (non-Sq and Sq).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesAustralia, Austria, Canada, France, Germany, Italy, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2016
Enrollment StartMay 2016
Primary CompletionJul 2019
Study CompletionJan 2022
TodayJul 2026
First PostedMar 21, 2016
Enrollment StartMay 24, 2016
Primary CompletionJul 15, 2019
Study CompletionJan 18, 2022
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 10.3 years ago
Interventions
Nivolumabbiological