Phase 3 Study of MRTX849 vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutatio

Phase 1

• Conditions: Advanced Non-Small Cell Lung Cancer; MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: CTIS2023-507263-19-00
• Lead Sponsor: Mirati Therapeutics Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-05
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 628

Inclusion Criteria

Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation., Candidacy to receive treatment with docetaxel., Crossover Inclusion Criteria: Evidence of RECIST 1.1 defined disease progression on docetaxel per BICR, Crossover Inclusion Criteria: ECOG performance status 0 - 2.

Exclusion Criteria

Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510, sotorasib)., Active brain metastases, Crossover Exclusion Criteria: Receipt of any other systemic anti-cancer therapy after last administration of docetaxel on the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: Evaluate secondary efficacy endpoints in the study population., Evaluate the safety and tolerability in the study population., Evaluate the pharmacokinetics of MRTX849 administered in the study population., Evaluate health-related quality of life and cancer-specific symptoms in the study population.;Primary end point(s): Progression-free Survival (PFS) Defined as time from randomization until disease progression or death from any cause, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Secondary efficacy endpoints:- Overall Survival (OS)- Objective Response Rate (ORR),- Duration of Response (DOR), and- 1-Year Survival Rate.;Secondary end point(s):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.;Secondary end point(s):Population PK parameters of MRTX849.;Secondary end point(s):Patient Reported Outcome (PRO) scores using the following:- Lung Cancer Symptom Scale (LCSS), and- European Quality of Life Five Dimensions Questionnaire(EQ-5D-5L).