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NCT07156604Not yet recruitingPhase 2

Vebreltinib for Neoadjuvant in METex 14 Skipping Mutant Stage IIA-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)

Vebreltinib for Neoadjuvant Treatment in Patients With Stage IIA-IIIB (N2) Non-small Cell Lung Cancer (NSCLC) Harboring METex 14 Skipping Mutant

Source: ClinicalTrials.gov · Last updated 5 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
30 (estimated)
First submitted
28 Aug 2025
Start date
30 Sept 2025
Primary completion date
30 Sept 2027
Lead sponsor
Fudan University
Diseases
Lung cancer
NCT number
NCT07156604

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 30
  • From 30 Sept 2025 to the primary completion date, 30 Sept 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previously received targeted therapy (including TKI or monoclonal antibodies), immunotherapy, or any investigational drug treatment for NSCLC;
  • Patients with a malignancy other than NSCLC within five years prior to the start of this trial,except for cured basal cell carcinoma of the skin, early gastrointestinal (GI) carcinoma excised through endoscopy, cervical carcinoma in situ, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, or any cured cancer deemed to have no impact on the survival of the current NSCLC;
  • Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (\>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;
  • Received other major surgical treatments (excluding diagnosis) within 4 weeks prior to the start of the study or expected to undergo major surgical treatments during the study period;

Other illness

  • Pathological confirmation of mixed small cell and non-small cell lung cancer;
  • Patients with congenital or acquired immune dysfunction (such as HIV infected individuals);
  • Participants who are allergic to the test drug or any auxiliary materials; 8.A history of extensive diffuse bilateral interstitial fibrosis in the past or before medication, or a known grade 3 or 4 history of interstitial fibrosis or interstitial lung disease, including pneumonia, allergic pneumonia, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis, but not including local radiation pneumonia or radiation pulmonary fibrosis history;
  • Participants suffering from nervous system diseases or mental diseases that cannot cooperate

Other

  • Pregnant or lactating women;
  • Any malabsorption;
  • Other factors that researchers think it is not suitable for enrollment.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fudan University Shanghai Cancer Center, Shanghai,
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.