NCT07156604

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• NSCLC
• Neoadjuvant Therapy

Interventions

Type	Name	Description
DRUG	Vebreltinib Enteric Capsules	treated with Vebreltinib (200 mg bid po) for 8 weeks before surgery.

Timeline

• Start date: 2025-09-30
• Primary completion: 2027-09-30
• Completion: 2030-09-30
• First posted: 2025-09-05
• Last updated: 2025-09-05

Locations

1 site across 1 country: China