Vebreltinib Plus Chemotherapy as First-line Treatment for MET-overexpressing NSCLC (NCT07549061) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Vebreltinib Plus Chemotherapy as First-line Treatment for MET-overexpressing NSCLC
China19 participantsStarted 2026-03-30
Plain-language summary
To explore the efficacy and safety of vebreltinib plus platinum-doublet chemotherapy as first-line therapy in patients with driver gene-negative, locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET overexpression.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Voluntarily sign a written informed consent form (ICF) to participate in the study; be willing and able to comply with study-related visits and procedures.
✓. Male or female subjects aged 18 years or older.
✓. Pathologically confirmed non-small cell lung cancer (NSCLC); outside hospital pathology reports are acceptable.
✓. Newly diagnosed metastatic NSCLC (clinical Stage IVA or IVB) or recurrent NSCLC (staged in accordance with the AJCC Cancer Staging Manual 9th edition), not eligible for curative-intent surgery or radiotherapy.
✓. Treatment-naïve advanced NSCLC not amenable to curative surgery or radiotherapy. For recurrent disease, prior adjuvant and neoadjuvant therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agents), or definitive radiotherapy/chemoradiotherapy with or without immunotherapy, biologic therapy, or investigational agents is permitted if completed at least 12 months before disease recurrence.
✓. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2.
✓. Driver gene-negative status confirmed by tumor tissue or blood sample, including but not limited to negative EGFR mutation, negative ALK rearrangement, negative ROS1 rearrangement, negative KRAS G12C mutation, and negative MET exon 14 skipping mutation. MET amplification is permitted: FISH demonstrating GCN ≥ 4 or MET/CEP7 ≥ 2, or positive result confirmed by NGS.
✓. MET protein overexpression defined as ≥50% of tumor cells staining at IHC 2++ or stronger. Local laboratory IHC results are acceptable.
. Spinal cord compression. Symptomatic or unstable brain metastases, unless the patient has completed curative treatment, is not receiving corticosteroid therapy, and has maintained a stable neurological status for at least 2 weeks after completion of curative treatment and steroid therapy. Patients with asymptomatic brain metastases may be included if the investigator determines there is no immediate indication for curative treatment.
✕. Meeting any of the following prior treatment history criteria:
✕. Meeting any of the following cardiac function or disease criteria:
✕. Diagnosis of another active malignancy requiring treatment within the past 3 years, other than NSCLC. Excluded are completely resected basal cell and squamous cell skin cancer, and completely resected carcinoma in situ of any type.
✕. Presence of active infection, including but not limited to:
✕. Known hypersensitivity to drugs of the same class as the study drug or to any of its excipients.
✕. Any concurrent medical condition that may increase the risk of toxicity.