RecruitingPhase 3NCT06008119

Efficacy and Safety of Tunlametinib Plus Vemurafenib in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer

A Multicenter, Randomized, Open-label, Phase 3 Study to Evaluate the Efficacy and Safety of Tunlametinib Plus Vemurafenib in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer

Sponsor

Shanghai Kechow Pharma, Inc.

Enrollment

165 participants

Start Date

Oct 25, 2023

Study Type

INTERVENTIONAL

Conditions

Colorectal Cancer Metastatic

Summary

This is a multicenter, randomized, open-label, Phase 3 study

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two targeted drugs — tunlametinib and vemurafenib — in people with metastatic colorectal cancer (cancer that has spread) that carries a specific gene mutation called BRAF V600E. **You may be eligible if...** - You are between 18 and 70 years old - You have confirmed metastatic colorectal cancer with the BRAF V600E mutation - Your cancer has progressed on at least one prior treatment - You are in good general health (ECOG 0–1) - You have at least one tumor that can be measured on a scan - You have a life expectancy of at least 3 months **You may NOT be eligible if...** - You have previously received a BRAF or MEK inhibitor - You have active brain metastases - You have heart rhythm or liver problems that are not well controlled - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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