A Randomized Phase 3 Study of MRTX849 versus Docetaxel in Patients with Previously Treated Non-Small Cell Lung Cancer with KRAS G12C Mutatio

Phase 3

Recruiting

• Conditions: SCLC (Non-Small Cell Lung Cancer); Advanced Pulmonary Non-Small Cell Cancer; Metastatic Non- Small Cell Lung Cancer; 10027476

• Registration Number: NL-OMON56384
• Lead Sponsor: Mirati Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

Histologically or cytologically confirmed diagnosis of NSCLC with KRAS
G12C mutation.
Candidacy to receive treatment with docetaxel.

Crossover Inclusion Criteria
1. Evidence of RECIST 1.1 defined disease progressoin on docetaxel per BICR.
2. ECOG performance status 0 - 2.

Exclusion Criteria

Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510).
Active brain metastases.

Crossover Exclusion Criteria:
1. Receipt of any other systemic anti-cancer therapy after last administration
of docetaxel on the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Progression-Free Survival (PFS)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Secondary efficacy endpoints:<br /><br>* Overall Survival (OS)<br /><br>* Objective Response Rate (ORR),<br /><br>* Duration of Response (DOR), and<br /><br>* 1-Year Survival Rate.</p><br>