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 cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2020-003645-11-PT

Lead Sponsor: Mirati Therapeutics, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 340

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 progression on docetaxel per BICR
2. ECOG performance status 0 - 2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 170

Exclusion Criteria

• Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510, sotorasib).
• 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 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: • To evaluate secondary efficacy endpoints in the study population.<br>• To evaluate the safety and tolerability in the study population.<br>• To evaluate the pharmacokinetics (PK) of MRTX849 administered in the study population.<br>• To evaluate health-related quality of life (HRQOL) and lung cancer-specific symptoms in the study population.<br>;Primary end point(s): - Progression-free Survival (PFS)<br><br>;Timepoint(s) of evaluation of this end point: 30 months<br>

Secondary Outcome Measures

Name	Time	Method
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.<br>• Secondary efficacy endpoints:<br>- Overall Survival (OS),<br>- Objective Response Rate (ORR),<br>- Duration of Response (DOR), and<br>- 1-Year Survival Rate.<br>• Plasma PK parameters of MRTX849 (and metabolites, if applicable).<br>• Patient Reported Outcome (PRO) scores using the following:<br>- Lung Cancer Symptom Scale (LCSS), and<br>- European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).;Timepoint(s) of evaluation of this end point: 30 Months