Non-small cell lung cancer
Conditions
Brief summary
Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per BICR.
Detailed description
Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, laboratory abnormalities, and number of patients modifying or discontinuing study treatment due to an AE., Secondary efficacy endpoints: Overall Survival (OS), Progression-Free Survival (PFS) per BICR, Duration of Response (DOR) per BICR., Summary statistics of adagrasib plasma concentrations., Patient-Reported Outcome (PRO) scores using PRO-CTCAE and EQ-5D-5L.
Interventions
DRUGAdagrasib
Sponsors
Mirati Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per BICR. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of AEs, laboratory abnormalities, and number of patients modifying or discontinuing study treatment due to an AE., Secondary efficacy endpoints: Overall Survival (OS), Progression-Free Survival (PFS) per BICR, Duration of Response (DOR) per BICR., Summary statistics of adagrasib plasma concentrations., Patient-Reported Outcome (PRO) scores using PRO-CTCAE and EQ-5D-5L. | — |
Countries
Croatia, France, Greece, Hungary, Italy, Netherlands, Poland, Romania, Spain
Outcome results
None listed