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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)

NCT02041533

Description:

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

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice <span class="go-doc-concept go-doc-intervention">Chemotherapy</span> as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell <span class="go-doc-concept go-doc-disease">Lung Cancer</span> (CheckMate 026)

Title

  • Brief 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 (CheckMate 026)
  • 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
  • Clinical Trial IDs

    NCT ID: NCT02041533

    ORG ID: CA209-026

    NCI ID: 2012-004502-93

    Trial Conditions

    Stage IV or Recurrent Non-Small Cell Lung Cancer

    Trial Interventions

    Drug Synonyms Arms
    Gemcitabine Gemzar Arm B: Investigator's Choice Chemotherapy
    Cisplatin Platinol Arm B: Investigator's Choice Chemotherapy
    Carboplatin Paraplatin Arm B: Investigator's Choice Chemotherapy
    Paclitaxel Taxol Arm B: Investigator's Choice Chemotherapy
    Pemetrexed Alimta Arm B: Investigator's Choice Chemotherapy

    Trial Purpose

    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

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Arm A: Nivolumab subjects 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
    Arm B: Investigator's Choice Chemotherapy 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 Gemcitabine, Cisplatin, Carboplatin, Paclitaxel, Pemetrexed

    Eligibility Criteria

    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

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Progression Free Survival (PFS) as assessed by independent radiology review committee (IRRC) in subjects with strongly Programmed death-ligand 1+ (PD-L1+) tumor expression

    Secondary Outcome Measures

    Objective response rate (ORR) as determined per IRRC in subjects with strongly PD-L1+ tumor expression

    Overall survival (OS) in subjects with strongly PD-L1+ tumor expression

    PFS in all subjects with any PD-L1+ tumor expression

    Disease related symptom improvement in all subjects

    Trial Keywords