This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation.
Name: MRTX849
Name: Docetaxel
Description: Defined as time from date of randomization to date of death due to any cause.
Measure: Overall Survival (OS) Time: 30 monthsDescription: Defined as time from randomization until disease progression or death from any cause, whichever occurs first.
Measure: Progression-free Survival (PFS) Time: 30 monthsDescription: Defined as number of patients with treatment emergent AEs
Measure: Adverse Events Time: 30 MonthsDescription: Defined as the percent of patients documented to have a confirmed CR or PR.
Measure: Objective Response Rate (ORR) Time: 30 MonthsDescription: Defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first.
Measure: Duration of Response (DOR) Time: 30 MonthsDescription: To be assessed by Lung Cancer Symptom Scale (LCSS).
Measure: Patient Reported Outcomes (PROs) Time: 30 MonthsDescription: To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).
Measure: Quality of LIfe Assessment Time: 30 MonthsAllocation: Randomized
Parallel Assignment
There is one SNP
A Randomized Phase 3 Study of MRTX849 Versus Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation. --- G12C ---
Phase 3 Study of MRTX849 vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation. --- G12C ---
Phase 3 Study of MRTX849 vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation. --- G12C --- --- G12C ---
To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).. Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation. --- G12C ---
Exclusion Criteria: - Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510). --- G12C ---
Inclusion Criteria: - Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation. --- G12C ---