Recruiting nowPhase 3Randomised
What this trial is trying to do
The trial is testing whether tunlametinib plus vemurafenib, which together target signalling driven by the BRAF V600E cancer mutation, can control metastatic colorectal cancer after it has progressed on at least one metastatic-treatment regimen. It is being compared with the investigator’s choice of chemotherapy, with or without bevacizumab or cetuximab.
The researchers expect that blocking the BRAF-driven pathway may keep the cancer from growing for longer than the available chemotherapy-based choices. The main measure is progression-free survival—how long people live before the cancer worsens—not overall survival.
Worth knowing: This is an open-label trial, so patients and clinicians know which treatment is being given, and the treatment is being tested only in people whose tumours have a BRAF V600E mutation.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT06008119 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 3 |
| Design | randomised, open label |
| Taking part | 165 people (planned) |
| Who can join | aged 18 Years to 70 Years |
| Run by | Shanghai Kechow Pharma, Inc. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Tunlametinib plus Vemurafenib
- Drug Doublets Chemotherapy ± Bevacizumab or Doublets Chemotherapy ± Cetuximab
What it is measuring
Progression-free Survival (PFS)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 3. Compares the treatment against current standard care in a large group. This is the design that changes practice.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- BRAF V600E
- Metastatic
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
- Inclusion Criteria:
1. Before study entry, written informed consent must be obtained from the patient prior to performing any study-related procedures.
2. Male or female patients with 18 to 70 years of age at time of informed consent;
3. Histological or cytologically confirmed metastatic CRC
4. 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)
5. 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.
6. Progression of disease after 1 or more prior regimens in the metastatic setting
7. At least 1 site of radiographically measurable disease by RECIST 1.1
8. Eastern Cooperative Oncology Group (ECOG) Performance Status(PS) of 0 to 1;
9. Life expectancy ≥ 3 months;
10. Can swallow the medicine,
11. Adequate hematologic, renal, cardiac and liver function as defined by laboratory values performed within 7 days prior to initiation of dosing:
12. Be willing and able to complete all the study procedures and follow-up examinations.
Exclusion Criteria
- Exclusion Criteria:
1. Prior treatment with any BRAF and MEK inhibitor;
2.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: China.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT06008119, registered by Shanghai Kechow Pharma, Inc. on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.