New pill may shrink lung tumors before surgery in Gene-Mutated cancers
NCT ID NCT07156604
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This phase 2 trial tests the drug Vebreltinib, taken as a pill for 8 weeks before surgery, in 30 people with stage IIA-IIIB non-small cell lung cancer that has a specific gene change (MET exon 14 skipping). The goal is to see if the drug can shrink tumors enough to improve surgery results. Participants will be followed for up to 3 years after surgery to monitor recurrence and survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vebreltinib (a targeted cancer pill)
- What this could lead to
- If successful, this could show that taking Vebreltinib before surgery helps shrink lung tumors with a specific gene change, potentially improving surgical outcomes.
- What could go wrong
- This is a small, early-phase trial with only 30 people, so results may not apply widely. The drug may cause side effects or fail to improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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; * Patients with congenital or acquired immune dysfunction (such as HIV infected individuals); * 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; * 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; * Pregnant or lactating women; * Any malabsorption; * Participants suffering from nervous system diseases or mental diseases that cannot cooperate * Other factors that researchers think it is not suitable for enrollment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fudan University Shanghai Cancer Center, Shanghai,
Shanghai, China
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- Can immunotherapy before surgery shrink head and neck tumors?
- Can a Triple-Drug combo before surgery eliminate EGFR-Mutant lung cancer?
- Can a new targeted drug shrink lung tumors?
- Can a targeted drug delivery system shrink lung tumors?