Advanced Non-Small Cell Lung Cancer
Conditions
Brief summary
Progression-free Survival (PFS) Defined as time from randomization until disease progression or death from any cause, whichever occurs first.
Detailed description
Secondary efficacy endpoints:- Overall Survival (OS)− Objective Response Rate (ORR),− Duration of Response (DOR), and− 1-Year Survival Rate., Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events (AEs), laboratory abnormalities, and number of patients discontinuing study treatment due to an adverse event., Population PK parameters of MRTX849., Patient Reported Outcome (PRO) scores using the following:− Lung Cancer Symptom Scale (LCSS), and− European Quality of Life Five Dimensions Questionnaire(EQ-5D-5L).
Interventions
Sponsors
Mirati Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival (PFS) Defined as time from randomization until disease progression or death from any cause, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy endpoints:- Overall Survival (OS)− Objective Response Rate (ORR),− Duration of Response (DOR), and− 1-Year Survival Rate., Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events (AEs), laboratory abnormalities, and number of patients discontinuing study treatment due to an adverse event., Population PK parameters of MRTX849., Patient Reported Outcome (PRO) scores using the following:− Lung Cancer Symptom Scale (LCSS), and− European Quality of Life Five Dimensions Questionnaire(EQ-5D-5L). | — |
Countries
Austria, Belgium, Czechia, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Romania, Spain
Outcome results
None listed