Non-Small Cell Lung Cancer
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Confirmed stage IV or recurrent EGFR Mutation (MT)+ NSCLC with disease progression after 1 prior EGFR tyrosine kinase inhibitor(TKI) therapy No evidence of exon 20 T790M mutation after progression on prior 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) and exon 20 T790M testing if CNS metastases are adequately treated and subjects are neurologically returned to baseline
Exclusion criteria
Exclusion criteria: Subjects with carcinomatous meningitis Subjects with an active, known or suspected autoimmune disease Subjects with known SCLC transformation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Progression-free survival(PFS) To compare PFS among nivolumab plus pemetrexed/platinum or nivolumab plus ipilimumab and pemetrexed/platinum alone | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Overall survival To compare OS among nivolumab plus pemetrexed/platinum or nivolumab plus ipilimumab and pemetrexed/platinum alone | — |
Countries
Canada, China, France, Hong Kong, Korea, Republic of, Singapore, Spain, Taiwan, United States
Contacts
Bristol-Myers Squibb