Overview

This trial is active, not recruiting.

Condition stage iv or recurrent non-small cell lung cancer
Treatments nivolumab, gemcitabine, cisplatin, carboplatin, paclitaxel, pemetrexed
Phase phase 3
Target PD-1
Sponsor Bristol-Myers Squibb
Collaborator Ono Pharmaceutical Co. Ltd
Start date March 2014
End date July 2016
Trial size 535 participants
Trial identifier NCT02041533, 2012-004502-93, CA209-026

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure
nivolumab BMS-936558
(Active Comparator)
Investigator'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
nivolumab BMS-936558
gemcitabine Gemzar
cisplatin Platinol
carboplatin Paraplatin
paclitaxel Taxol
pemetrexed Alimta

Primary Outcomes

Measure
Progression Free Survival (PFS) as assessed by independent radiology review committee (IRRC) in subjects with strongly Programmed death-ligand 1+ (PD-L1+) tumor expression
time frame: Up to approximately 33 months

Secondary Outcomes

Measure
Objective response rate (ORR) as determined per IRRC in subjects with strongly PD-L1+ tumor expression
time frame: Up to approximately 33 months
Overall survival (OS) in subjects with strongly PD-L1+ tumor expression
time frame: At least 33 months
PFS in all subjects with any PD-L1+ tumor expression
time frame: Up to approximately 33 months
Disease related symptom improvement in all subjects
time frame: Up to approximately 33 months

Eligibility Criteria

Male or female participants at least 18 years old.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1 - Histologically confirmed Stage IV, or Recurrent NSCLC with no prior systemic anticancer therapy - Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per response evaluation criteria in solid tumors version (RECIST) 1.1 criteria - PD-L1+ on immunohistochemistry testing performed by central lab - Men and women, ages ≥ 18 years of age Exclusion Criteria: - Known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy - Known anaplastic lymphoma kinase (ALK) translocations - Untreated central nervous system (CNS) metastases - Previous malignancies - Active, known or suspected autoimmune disease

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.