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Colorectal Cancer MetastaticPhase 3NCT06008119

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

A Phase 3 study testing Tunlametinib plus Vemurafenib and Doublets Chemotherapy ± Bevacizumab or Doublets Chemotherapy ± Cetuximab in people with Colorectal Cancer Metastatic, run by Shanghai Kechow Pharma, Inc. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a multicenter, randomized, open-label, Phase 3 study Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Colorectal Cancer Metastatic
What is being tested?
Tunlametinib plus Vemurafenib and Doublets Chemotherapy ± Bevacizumab or Doublets Chemotherapy ± Cetuximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
165 participants
Where
1 siteChina
Study dates
25 Oct 2023to 24 Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Before study entry, written informed consent must be obtained from the patient prior to performing any study-related procedures.
  • Male or female patients with 18 to 70 years of age at time of informed consent;
  • Histological or cytologically confirmed metastatic CRC
  • Presence of BRAFV600E in tumor tissue as previously determined by a local assay at any time prior to Screening or by the central laboratory (BRAFV600 is permitted)
  • Able to provide a sufficient amount of representative tumor specimen (primary or metastatic, archival or newly obtained) for confirmatory central laboratory testing of BRAF mutation status.
  • Progression of disease after 1 or more prior regimens in the metastatic setting
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  • At least 1 site of radiographically measurable disease by RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status(PS) of 0 to 1;
  • Life expectancy ≥ 3 months;
  • Can swallow the medicine,
  • Adequate hematologic, renal, cardiac and liver function as defined by laboratory values performed within 7 days prior to initiation of dosing:
  • Be willing and able to complete all the study procedures and follow-up examinations.

Who cannot join

  • Prior treatment with any BRAF and MEK inhibitor;
  • Known contraindication to receive the treatment of control arm (according to latest PI).
  • Symptomatic brain metastasis or leptomeningeal disease
  • History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to randomization
  • Known history of acute or chronic pancreatitis
  • Uncontrolled GI bleeding, Dysphagia，refractory nausea, vomiting, small bowel resection or any other gastrointestinal ailment that would preclude study drug absorption.
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  • Serious cardiovascular disease , including uncontrolled congestive heart failure, uncontrolled hypertension, cardiac ischemia, myocardial infarction, and severe cardiac arrhythmia , deep vein thrombosis or pulmonary emboli or cerebrovascular events ≤ 6 months prior to starting study treatment;
  • History or current evidence of retinal vein occlusion or current risk factors for retinal vein occlusion (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes)
  • Concurrent neuromuscular disorder that is associated with the potential of elevated creatine (phosphor)kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
  • Uncontrolled blood pressure despite medical treatment
  • Concurrent or previous other malignancy within 5 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, or other noninvasive or indolent malignancy
  • Residual common terminology criteria for adverse events (CTCAE) ≥ Grade 2 toxicity from any prior anticancer therapy, with the exception of Grade 2 alopecia or Grade 2 neuropathy
  • Anti-HIV(+) , Anti-TP( +); Active hepatitis B or hepatitis C infection …….

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Beijing Oncology Hospital

    Beijing, Beijing Municipality

    Lin Shen, 86+10-88196561, doctorshenlin@sina.cn

    Recruiting

Other trials in China

About this study

Official title: 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

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

Read the 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.

Being tested
Tunlametinib plus Vemurafenib, Doublets Chemotherapy ± Bevacizumab or Doublets Chemotherapy ± Cetuximab
Keywords
BRAFV600E mutant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tunlametinib plus VemurafenibDrug

    12mg BID Tunlametinib+720mg BID Vemurafenib

  • Doublets Chemotherapy ± Bevacizumab or Doublets Chemotherapy ± CetuximabDrug

    According to investigators' suggestion

Study groups in NCT06008119
Study groupRoleWhat they receive
ExperimentalExperimentalTunlamatinib plus Vemurafenib
Receives: Drug: Tunlametinib plus Vemurafenib
ControlActive comparatorInvestigators' choice
Receives: Drug: Doublets Chemotherapy ± Bevacizumab or Doublets Chemotherapy ± Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    defined as the time from first dose to the earliest documented disease progression or death due to any cause

    Measured: up to 12 months

Secondary outcomes (4)

  1. Overall Survival（OS）

    defined as the time from the date of taking drugs to the date of death due to any cause.

    After disease progression, participants in the control group can crossover to receive the experimental drug treatment if they meet the crossover enrollment criteria. The median survival time of the two groups will be estimated by Kaplan-Meier method, and the hazard ratio (HR) between the two groups will be estimated use the Cox proportional hazards model in FAS, and OS will be adjusted using the following two methods:

    1. Rank Preserving Structural Failure Time Model (RPSFTM): Corrects survival outcomes for treatment crossover from the control group to the experimental group by estimating counterfactual survival times to infer the treatment effect without crossover.
    2. Inverse Probability of Censoring Weighting (IPCW): Adjusts for informative censoring bias caused by treatment crossover. The weights will be derived from time-dependent censoring models.

    Measured: up to 12 months

  2. Overall Response Rate（ORR）

    Defined as the proportion of subjects with an optimal response of CR or PR over the course of the study from enrollment to disease progression

    Measured: up to 12 months

  3. Duration of Response（DOR）

    Defined as the time from the first CR or PR evaluation of tumor efficacy to the first occurrence of PD or death from any cause (whichever occurs first)

    Measured: up to 12 months

  4. Disease control rate (DCR)

    roportion of subjects with response defined as CR, PR, and SD throughout the study from subjects first dose to disease progression or death

    Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2023
  2. Study start25 Oct 2023
  3. Primary completion24 Dec 2026 (estimated)
  4. Study completion24 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
165 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06008119
Sponsor's protocol ID
HL-085-304
Status last verified
Feb 2026
First submitted
8 Aug 2023
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tunlametinib plus Vemurafenib and Doublets Chemotherapy ± Bevacizumab or Doublets Chemotherapy ± Cetuximab in people with Colorectal Cancer Metastatic, run by Shanghai Kechow Pharma, Inc. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06008119.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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