Trials / Recruiting
RecruitingNCT06008119
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 165 (estimated)
- Sponsor
- Shanghai Kechow Pharma, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, randomized, open-label, Phase 3 study
Detailed description
This is a multicenter, randomized, open-label, Phase 3 study to evaluate Tunlamatinib plus Vemurafenib versus Investigator's choice of Chemotherapy based treatment as controls in patients with BRAFV600E mutant Metastatic Colorectal Cancer (CRC) whose disease has progressed after 1 or more prior regimens in the metastatic setting.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tunlametinib plus Vemurafenib | 12mg BID Tunlametinib+720mg BID Vemurafenib |
| DRUG | Doublets Chemotherapy ± Bevacizumab or Doublets Chemotherapy ± Cetuximab | According to investigators' suggestion |
Timeline
- Start date
- 2023-10-25
- Primary completion
- 2026-12-24
- Completion
- 2026-12-24
- First posted
- 2023-08-23
- Last updated
- 2025-09-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06008119. Inclusion in this directory is not an endorsement.