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 range18 Years

SexALL

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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…

What they're measuring

Major pathologic response (MPR) rate

Timeframe: Up to 30 months

Trial details

NCT IDNCT07156604

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-30

Contact for this trial

Tong Li, PHD

86+18813039287 litong_medical@163.com