Description:
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.
Title
- Brief Title: Phase 3 Study of MRTX849 vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation
- Official Title: A Randomized Phase 3 Study of MRTX849 Versus Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation
Clinical Trial IDs
- ORG STUDY ID:
849-012
- NCT ID:
NCT04685135
Conditions
- Metastatic Non Small Cell Lung Cancer
- Advanced Non Small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
MRTX849 | | MRTX849 |
Docetaxel | Taxotere | Docetaxel |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
MRTX849 | Experimental | | |
Docetaxel | Active Comparator | | |
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation.
- Candidacy to receive treatment with docetaxel.
Exclusion Criteria:
- Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510).
- Active brain metastases.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall Survival (OS) |
Time Frame: | 30 months |
Safety Issue: | |
Description: | Defined as time from date of randomization to date of death due to any cause. |
Secondary Outcome Measures
Measure: | Adverse Events |
Time Frame: | 30 Months |
Safety Issue: | |
Description: | Defined as number of patients with treatment emergent AEs |
Measure: | Objective Response Rate (ORR) |
Time Frame: | 30 Months |
Safety Issue: | |
Description: | Defined as the percent of patients documented to have a confirmed CR or PR. |
Measure: | Duration of Response (DOR) |
Time Frame: | 30 Months |
Safety Issue: | |
Description: | 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: | Patient Reported Outcomes (PROs) |
Time Frame: | 30 Months |
Safety Issue: | |
Description: | To be assessed by Lung Cancer Symptom Scale (LCSS). |
Measure: | Quality of LIfe Assessment |
Time Frame: | 30 Months |
Safety Issue: | |
Description: | To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L). |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Mirati Therapeutics Inc. |
Trial Keywords
- KRAS G12C
- Non-small cell lung cancer
- NSCLC
- Metastatic Cancer
- Docetaxel
- Phase 3 Clinical Trial
Last Updated
August 17, 2021