Vebreltinib for Neoadjuvant in METex 14 Skipping Mutant Stage IIA-IIIB (N2) Non-small Cell Lung C… (NCT07156604) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Vebreltinib for Neoadjuvant in METex 14 Skipping Mutant Stage IIA-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)
China30 participantsStarted 2025-09-30
Plain-language summary
This is a prospective, single-center phase II clinical study aimed at evaluating the efficacy and safety of Vebreltinib in neoadjuvant treatment for patients with resectable stage IIA-IIIB (N2) non-small cell lung cancer (NSCLC) with MET exon 14 skipping mutations. In the study, all eligible subjects who signed the informed consent and met the inclusion and exclusion criteria were treated with Vebreltinib (200 mg bid po) for 8 weeks before surgery. The subjects were evaluated by the investigators and the surgical resection was performed within approximately 2 weeks after the neoadjuvant treatment. The study used RECIST v1.1 for imaging assessment. A CT or enhanced CT scan was conducted within 2 weeks after the end of treatment, and then every 180 days (±14) after surgery until 3 years, and then annually until disease recurrence or death, or the end of the study.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The patient shall sign the Informed Consent Form.
* Aged 18 ≥ years.
* Histological or cytological diagnosis of NSCLC by needle biopsy, and evaluated by researchers as stage IIA-IIIB(N2).
* NGS gene testing confirmed MET exon 14 skipping mutations (NGS results from tissue or blood samples certified by CLIA or CAP-approved laboratories);
* Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
* According to the MDT evaluation (which should include a thoracic surgeon specializing in tumor surgery), it is considered that the primary NSCLC is potentially completely resectable;
* At least 1 measurable lesion according to RECIST 1.1.
* Patients with good function of other main organs (liver, kidney, blood system, etc.)
* Patients with lung function can tolerate surgery;
* Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of toripalimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.
* Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 d
Exclusion Criteria:
* Previously received targeted therapy (including TKI or monoclonal antibodies), immunotherapy, or any investigational drug treatment for NSCLC;
* Pathological confirmation of mixed small cell and non-small cell lung cancer;
* Patients with a malignancy ot…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.