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Recruiting
NCT07549061
Vebreltinib Plus Chemotherapy as First-line Treatment for MET-overexpressing NSCLC
Conditions: NSCLC (Advanced Non-small Cell Lung Cancer)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 19
Sponsor: Shanghai Chest Hospital
Location: 241 West Huaihai Road, Xuhui District, Shanghai, 200030, China. Shanghai Shanghai Municipality
Summary
To explore the efficacy and safety of vebreltinib plus platinum-doublet chemotherapy as first-line therapy in patients with driver mutation-negative, MET-overexpressing, PD-L1 TPS \< 50%, locally advanced or metastatic NSCLC .
Eligibility Criteria
Inclusion criteria
Patients must meet all of the following inclusion criteria:
1. Provide written informed consent before initiation of any study-specific procedure and be willing and able to comply with study procedures.
2. Be aged ≥18 years.
3. Have histologically or cytologically confirmed NSCLC. (pathology reports from outside institutions are acceptable).
4. Have newly diagnosed locally advanced or metastatic NSCLC that is not amenable to curative surgery or radiotherapy according to the AJCC 9th edition staging system.
5. Have no prior systemic anticancer therapy for advanced or metastatic disease. Prior neoadjuvant or adjuvant systemic therapy, definitive chemoradiotherapy or radiotherapy is permitted provided that treatment was completed ≥12 months before recurrence.
6. Have an ECOG performance status of 0-2.
7. Have no actionable driver oncogene alteration identified by tissue and/or blood-based molecular testing. At a minimum, testing must exclude EGFR sensitising mutations, ALK rearrangements, ROS1 rearrangements, RET fusions, NTRK fusions, KRAS G12C mutations, BRAF V600E mutations, MET exon 14 skipping alterations and other actionable alterations according to current clinical practice and locally available testing. Concurrent MET amplification is permitted provided that the tumour meets the prespecified MET protein overexpression criterion.
8. Have MET protein overexpression, defined as moderate-to-strong (2+ or 3+) MET staining in ≥50% of viable tumour cells by IHC.
9. Have a PD-L1 TPS \
Source: ClinicalTrials.gov (NCT07549061). StuddyBuddy aggregates publicly available trial information.