A Randomized Phase 3 Study of MRTX849 in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First- Line Therapy

Phase 1

Conditions: Advanced Colorectal Cancer with KRAS G12C Mutation
MedDRA version: 21.0Level: PTClassification code: 10052358Term: Colorectal cancer metastatic Class: 100000004864
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2023-506241-30-00

Lead Sponsor: Mirati Therapeutics Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 561

Inclusion Criteria

Histologically confirmed diagnosis of colorectal carcinoma G12C mutation in tumor tissue., Prior receipt of 1st line treatment in advanced CRC with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan, and radiographically documented progression of disease on or after treatment.

Exclusion Criteria

Prior treatment with both an oxaliplatin-and irinotecan-based regimen for CRC, concurrently or successively, in any setting (neoadjuvant, adjuvant or advanced)., Prior treatment with a therapy targeting KRAS G12C mutation (e.g., sotorasib)., Prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of adagrasib in combination with cetuximab versus chemotherapy (FOLFIRI or mFOLFOX6) administered in the second-line treatment setting to patients with CRC with KRAS G12C mutation.;Secondary Objective: To evaluate secondary efficacy endpoints in the study population., To evaluate the safety and tolerability in the study population., To evaluate the pharmacokinetics (PK) of adagrasib administered in combination with cetuximab., To evaluate health-related quality of life (HRQOL) and cancer-related symptoms in the study population.;Primary end point(s): Overall Survival (OS), Progression-free Survival (PFS)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Adverse Events;Secondary end point(s):Objective Response Rate (ORR);Secondary end point(s):Duration of Response (DOR);Secondary end point(s):Patient Reported Outcomes (PROs);Secondary end point(s):Quality of Life Assessment