ClinicalTrials.Veeva

Menu

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) logo

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)

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

Trial contacts and locations

141

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems