Clinical Trials/NCT02041533

NCT02041533

Completed

Phase 3

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

Bristol-Myers Squibb141 sites in 5 countries541 target enrollmentMarch 27, 2014

ConditionsStage IV or Recurrent Non-Small Cell Lung Cancer

InterventionsNivolumab Gemcitabine Cisplatin Carboplatin Paclitaxel Pemetrexed

DrugsGemcitabine Cisplatin Carboplatin Paclitaxel Pemetrexed

Overview

Phase: Phase 3
Intervention: Nivolumab
Conditions: Stage IV or Recurrent Non-Small Cell Lung Cancer
Sponsor: Bristol-Myers Squibb
Enrollment: 541
Locations: 141
Primary Endpoint: Progression-Free Survival in Participants With PD-L1 Expression >= 5%
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

March 27, 2014

End Date

May 27, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Arm A: Nivolumab subjects

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

Intervention: Nivolumab

Arm B: Investigator's Choice Chemotherapy

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

Intervention: Nivolumab

Arm B: Investigator's Choice Chemotherapy

Intervention: Gemcitabine

Arm B: Investigator's Choice Chemotherapy

Intervention: Cisplatin

Arm B: Investigator's Choice Chemotherapy

Intervention: Carboplatin

Arm B: Investigator's Choice Chemotherapy

Intervention: Paclitaxel

Arm B: Investigator's Choice Chemotherapy

Intervention: Pemetrexed

Outcomes

Primary Outcomes

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)

Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.

Secondary Outcomes

Progression-Free Survival in All Randomized Participants(From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months))
Overall Survival in Participants With PD-L1 Expression >= 5%(From date of randomization to date of death (up to approximately 89 months))
Overall Survival in All Randomized Participants(From date of randomization to date of death (up to approximately 89 months))
Objective Response Rate (ORR) in Participants With PD-L1 Expression >= 5%(From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to August 2016, approximately 28 months))
Disease-related Symptom Improvement Rate by Week 12(From date of randomization to week 12)