Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutatio

Phase 1

Conditions: Advanced Colorectal Cancer with KRAS G12C Mutation
MedDRA version: 21.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2020-004048-27-GR

Lead Sponsor: Mirati Therapeutics, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 420

Inclusion Criteria

- Histologically confirmed diagnosis of colorectal carcinoma with KRAS 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.
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 210
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 210

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., AMG 510).
- 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. <br>- To evaluate the safety and tolerability in the study population.<br>- To evaluate the pharmacokinetics (PK) of adagrasib administered in combination with cetuximab.<br>- To evaluate health-related quality of life (HRQOL) and cancer-related symptoms in the study population.<br>;Primary end point(s): - Overall Survival (OS)<br>- Progression-free Survival (PFS);Timepoint(s) of evaluation of this end point: 30 Months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Adverse Events<br>- Objective Response Rate (ORR) <br>- Duration of Response (DOR) <br>- Patient Reported Outcomes (PROs)<br>- Quality of Life Assessment ;Timepoint(s) of evaluation of this end point: 30 Months

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