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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 NSCLC Patients With EGFR Mutation Who Failed 1L or 2L 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 Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor Therapy

Clinical Trial IDs

  • ORG STUDY ID: CA209-722
  • SECONDARY ID: 2017-002672-38
  • NCT ID: NCT02864251

Conditions

  • Non-Small-Cell Lung Carcinoma

Interventions

DrugSynonymsArms
NivolumabOpdivo, BMS-936558Nivolumab+Platinum doublet chemotherapy
IpilimumabYervoy, BMS-734016Nivolumab + Ipilimumab
PemetrexedNivolumab+Platinum doublet chemotherapy
CisplatinNivolumab+Platinum doublet chemotherapy
CarboplatinNivolumab+Platinum doublet chemotherapy

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Nivolumab+Platinum doublet chemotherapyExperimentalSpecified dose on specified days
  • Nivolumab
  • Pemetrexed
  • Cisplatin
  • Carboplatin
Nivolumab + IpilimumabExperimentalSpecified dose on specified days Enrollment is closed for this arm
  • Nivolumab
  • Ipilimumab
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 mutated NSCLC with disease progression on one or
             two prior lines of treatment with EGFR TKIs (allowed TKIs must be approved by the
             local health authority, including but not limited to erlotinib, gefitinib, afatinib,
             dacomitinib and osimertinib).

          -  No evidence of exon 20 T790M mutation obtained at progression on prior first- or
             second-generation EGFR 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). For subjects who were treated with osimertinib, T790M testing is not required.

          -  Subjects are eligible if central nervous system (CNS) metastases are considered to be
             adequately controlled/treated before or during the screening period and subjects are
             neurologically returned to baseline (except for residual signs or symptoms related to
             the CNS treatment) for at least 2 weeks prior to randomization. In addition, subjects
             must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily
             prednisone (or equivalent) for at least 2 weeks prior to randomization). Subjects with
             asymptomatic CNS metastasis are eligible.

          -  Eastern Cooperative Group (ECOG) Performance Status 0-1

          -  Life expectancy is at least 3 months

        Exclusion Criteria:

          -  Subjects with known EGFR mutation, T790M positive who failed 1L first- or
             second-generation TKI should receive osimertinib first as the standard of care (SOC).
             These subjects are only eligible if they fail osimertinib as 2L.

          -  Subjects who have progressed within 3 months of the first dose of 1L or 2L EGFR TKI.

          -  Subjects with carcinomatous meningitis

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

          -  Subjects with ALK translocation

          -  Subjects with known SCLC transformation

          -  Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4
             antibody, or any other antibody or drug specifically targeting T-cell co-stimulation
             or checkpoint pathways

        Other protocol defined inclusion/exclusion criteria could apply
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression free survival (PFS) in participants with epidermal growth factor receptor (EGFR) mutation positive non-small cell lung carcinoma (NSCLC)
Time Frame:up to 47 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall survival (OS)
Time Frame:Up to 74 months
Safety Issue:
Description:
Measure:Objective response rate (ORR)
Time Frame:Up to 47 months
Safety Issue:
Description:
Measure:Duration of response (DOR)
Time Frame:Up to 47 months
Safety Issue:
Description:
Measure:Progression free survival (PFS) rate
Time Frame:Up to 47 months
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

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