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

Sponsor
Shanghai Kechow Pharma, Inc.
Study ID
NCT06008119
Phase
PHASE3
Status
Recruiting
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Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

First listed
Aug 23, 2023
Start date
Oct 25, 2023
Status verified
Feb 2025
Primary completion
Dec 24, 2026
Completion
Dec 24, 2026

Study Design

Enrollment
165 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    Tunlamatinib plus Vemurafenib
  • Active Comparator: Control
    Investigators' choice

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: up to 12 months ]

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