About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
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.
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.
Trial design
Treatments tested in this trial
- Vebreltinib
- Chemotherapy
Treatment groups
Sponsors and collaborators
Shanghai Chest Hospital
Lead sponsor
Shanghai Chest Hospital of Shanghai Jiao Tong University
Sponsor institution