Summary

for people ages 18 years and up (full criteria)
at UCLA
study started
estimated completion:

Description

Summary

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

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

Keywords

Non-Small-Cell Lung Carcinoma Lung Neoplasms Carcinoma, Non-Small-Cell Lung Nivolumab Carboplatin Pemetrexed Antibodies, Monoclonal Ipilimumab Cisplatin Nivolumab+Platinum doublet chemotherapy Nivolumab + Ipilimumab Platinum doublet chemotherapy

Eligibility

For people ages 18 years and up

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

Locations

  • UCLA Cancer Hematology Oncology accepting new patients
    Los Angeles California 90095 United States
  • Los Angeles Hematology Oncology Medical Group accepting new patients
    Los Angeles California 90017 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
ID
NCT02864251
Phase
Phase 3
Study Type
Interventional
Last Updated