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)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Stage IV or Recurrent Non-Small Cell Lung Cancer

Treatments: Drug: Paclitaxel; Drug: Pemetrexed; Drug: Gemcitabine; Biological: Nivolumab; Drug: Carboplatin; Drug: Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02041533

2012-004502-93 (EudraCT Number)

CA209-026

Details and patient eligibility

About

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

Enrollment: 541 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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541 participants in 2 patient groups

Arm A: Nivolumab subjects

Experimental group

Description:

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

Treatment:

Biological: Nivolumab

Arm B: Investigator's Choice Chemotherapy

Active Comparator group

Description:

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

Treatment:

Drug: Cisplatin

Drug: Carboplatin

Biological: Nivolumab

Drug: Gemcitabine

Drug: Pemetrexed

Drug: Paclitaxel