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-IE

Lead Sponsor: Mirati Therapeutics, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 450

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.
2.0 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 225
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 225

Exclusion Criteria

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

Crossover Inclusion Criteria
1. Receipt of any 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) Defined as time from randomization<br>until disease progression or death from any cause, whichever occurs<br>first.<br><br><br>;Timepoint(s) of evaluation of this end point: PFS - 32 months <br><br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): E5-2. Secondary end point(s) (max 5000 characters)<br>Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse<br>events (AEs),<br>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>• Population PK parameters of MRTX849.<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).<br>;Timepoint(s) of evaluation of this end point: 32 months (Primary efficacy endpoint PFS and Secondary efficacy<br>endpoint ORR) and 49 months (all other secondary endpoints)<br>