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 (CheckMate 026)
Part of paid clinical trials in Mobile, Alabama.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT02041533
- Phase
- PHASE3
- Status
- Completed
Conditions
- Stage IV or Recurrent Non-Small Cell Lung Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab — BIOLOGICAL
- Gemcitabine — DRUG
- Cisplatin — DRUG
- Carboplatin — DRUG
- Paclitaxel — DRUG
- Pemetrexed — DRUG
Study Details
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
Key Dates
- Start date
- Mar 27, 2014
- Status verified
- Feb 2023
- Primary completion
- Jul 1, 2016
- Completion
- May 27, 2022
Study Design
- Enrollment
- 541 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm A: Nivolumab subjectsNivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure
- Active Comparator: Arm B: Investigator's Choice ChemotherapyInvestigator's Choice Chemotherapy administered in 3-week cycles up to a maximum of 6 cycles of Intravenous injection until disease progression, unacceptable toxicity or completion of the 6 cycles, whichever comes first Squamous subjects: * Gemcitabine 1250 mg/mg(2) administered on Day 1 and Day 8 with Cisplatin 75 mg/m(2) administered on Day 1 of each cycle; or * Gemcitabine 1000 mg/mg(2) administered on Day 1 and Day 8 with Carboplatin (AUC 5) administered on Day 1 of each cycle; or * Paclitaxel 200 mg/m(2) with Carboplatin (AUC 6) administered on Day 1 of each cycle Non-Squamous subjects: * Pemetrexed 500 mg/m(2) with Cisplatin 75 mg/m(2) administered on Day 1 of each cycle * Pemetrexed 500 mg/m(2) Carboplatin (AUC 6) administered on Day 1 of each cycle Optional crossover: * Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent or study closure
Primary Outcome Measure
Progression-Free Survival in Participants With PD-L1 Expression >= 5% [ Time Frame: From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months) ]