NCT06644313

Vebreltinib for Neoadjuvant in MET-altered Stage IIIA-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

According to the 2024 edition of the NCCN guidelines and the 2023 edition of the CSCO guidelines, perioperative treatment is recommended for patients with stage IIIA and IIIB (T3N2) non-small cell lung cancer (NSCLC). Targeted therapies for NSCLC, such as EGFR inhibitors and ALK inhibitors, have been explored in the neoadjuvant setting. For patients with MET alterations, some have undergone preoperative MET inhibitor treatment, achieving pathological downstaging followed by surgery, resulting in R0 resection. Therefore, this is a prospective, cohort, single-center phase II clinical study to evaluate the efficacy and safety of Vebreltinib as a neoadjuvant treatment for patients with MET-altered stage IIIA-IIIB (N2) NSCLC.

Conditions

• Potentially Resectable MET-altered Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Vebreltinib	Neoadjuvant treatment stage: Vebreltinib 200mg, bid, po, 2-4 months in total; Surgical treatment stage: CR + PR patients and SD + PD patients who could still undergo surgery will receive radical surgery; Adjuvant treatment stage: CR, PR and SD patients who have been treated surgically: Vebreltinib 200mg, bid, po, up to 2 years/until the disease progressed. PD patients: transferred into medical oncology or/and radiation oncology and receive comprehensive therapy.

Timeline

• Start date: 2024-11-01
• Primary completion: 2029-11-01
• Completion: 2029-11-01
• First posted: 2024-10-16
• Last updated: 2024-10-16