Advanced Non-Small Cell Lung Cancer
Conditions
Brief summary
Cohorts A and E: Objective response rate (ORR), as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)., Cohort C: PFS at 6 months (PFS6)
Detailed description
Cohorts C and E: Dose-limiting toxicities (DLTs) during safety lead-in (SLI), Safety characterized by type, incidence, severity, timing, seriousness, and relationship to study treatment of adverse events (AEs) and laboratory abnormalities, Summary statistics of adagrasib concentrations, Secondary efficacy endpoints: Duration of response (DOR)
Interventions
DRUGAdagrasib
DRUGDEXAMETHASONE
DRUGCARBOPLATIN
DRUGPEMBROLIZUMAB
DRUGPEMETREXED
DRUGCISPLATIN
DRUGPALONOSETRON
Sponsors
Mirati Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohorts A and E: Objective response rate (ORR), as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)., Cohort C: PFS at 6 months (PFS6) | — |
Secondary
| Measure | Time frame |
|---|---|
| Cohorts C and E: Dose-limiting toxicities (DLTs) during safety lead-in (SLI), Safety characterized by type, incidence, severity, timing, seriousness, and relationship to study treatment of adverse events (AEs) and laboratory abnormalities, Summary statistics of adagrasib concentrations, Secondary efficacy endpoints: Duration of response (DOR) | — |
Countries
France, Greece, Hungary, Italy, Poland, Spain
Outcome results
None listed