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A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in NSCLC Patients With EGFR Mutation Who Failed 1L or 2L EGFR TKI Therapy

NCT02864251

Description:

The main purpose of this study is to determine whether nivolumab + chemotherapy is effective as compared to chemotherapy in the treatment of patients with EGFR mutation, NSCLC who failed first line (1L) or second-line (2L) EGFR TKI therapy.

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

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title:A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Patients With EGFR Mutation, T790M Negative NSCLC Who Have Failed 1L EGFR TKI Therapy
  • Official Title:Open-Label, Randomized Trial of Nivolumab (BMS-936558) Plus Pemetrexed/Platinum or Nivolumab Plus Ipilimumab (BMS-734016) vs Pemetrexed Plus Platinum in Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) Subjects With Epidermal Growth Factor Receptor (EGFR) Mutation, T790M Negative Who Failed 1L EGFR Tyrosine Kinase Inhibitor Therapy

Clinical Trial IDs

  • ORG STUDY ID: CA209-722
  • NCT ID: NCT02864251

Trial Conditions

  • Non-Small-Cell Lung Carcinoma

Trial Interventions

DrugSynonymsArms
PemetrexedNivolumab+Platinum doublet chemotherapy
CisplatinNivolumab+Platinum doublet chemotherapy
CarboplatinNivolumab+Platinum doublet chemotherapy

Trial Purpose

The purpose of this study is to determine whether Nivolumab+ chemotherapy and Nivolumab+Ipilimumab is effective in the treatment of patients with EGFR mutation, T790M negative NSCLC who failed first line (1L) EGFR TKI therapy

Detailed Description

Trial Arms

NameTypeDescriptionInterventions
Nivolumab+Platinum doublet chemotherapyExperimentalSpecified dose on specified days
      • Pemetrexed
      • Cisplatin
      • Carboplatin
Nivolumab + IpilimumabExperimentalSpecified dose on specified days
    Platinum doublet chemotherapyActive ComparatorSpecified dose on specified days
        • Pemetrexed
        • Cisplatin
        • Carboplatin

    Eligibility Criteria

    For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

    Inclusion Criteria:

    - Confirmed stage IV or recurrent EGFR Mutation (MT)+ NSCLC with disease progression after 1 prior EGFR TKI therapy

    - No evidence of exon 20 T790M mutation after progression on prior EGFR tyrosine kinase inhibitor(TKI) therapy.

    - Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

    - Available tumor sample for Programmed death-ligand 1 (PD-L1) immunohistochemical (IHC) and exon 20 T790M testing

    Exclusion Criteria:

    - Subjects with symptomatic central nervous system (CNS) metastases

    - Subjects with carcinomatous meningitis

    - Subjects with an active, known or suspected autoimmune disease are excluded

    - Subjects with known SCLC transformation

    Other protocol defined inclusion/exclusion criteria could apply

    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Both
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Progression free survival (PFS) in subjects with epidermal growth factor receptor (EGFR) mutation, T790M negative non-small cell lung carcinoma (NSCLC)
    Time Frame:up to 33 months
    Safety Issue:No
    Description:

    Secondary Outcome Measures

    Measure:Overall survival (OS)
    Time Frame:Up to 5 years
    Safety Issue:No
    Description:
    Measure:Objective response rate (ORR)
    Time Frame:Up to 33 months
    Safety Issue:No
    Description:
    Measure:Duration of response (DOR)
    Time Frame:Up to 33 months
    Safety Issue:No
    Description:
    Measure:Progression free survival (PFS) rate
    Time Frame:Up to 33 months
    Safety Issue:No
    Description:

    Trial Keywords