NCT07156604

Vebreltinib for Neoadjuvant in METex 14 Skipping Mutant Stage IIA-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)

Not yet recruiting Phase 2 Last updated 5 September 2025

What this trial tests

Phase 2 trial testing Vebreltinib Enteric Capsules in NSCLC in 30 participants. Not yet recruiting.

Timeline

30 September 2025

Primary endpoint
30 September 2027

30 September 2030

Quick facts

Lead sponsor	Fudan University
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	30 September 2025
Primary completion	30 September 2027
Estimated completion	30 September 2030
Sites	1 location across China

Drugs / interventions tested

• Vebreltinib Enteric Capsules — full drug profile →

Conditions studied

• NSCLC — all drugs for NSCLC →
• Neoadjuvant Therapy — all drugs for Neoadjuvant Therapy →

Sponsor

Fudan University

Who can join

18 and older, any sex, with NSCLC or Neoadjuvant Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting MET in non-small cell lung cancer brain metastases: from molecular mechanism to precision therapy.
   Wang X, Chi Y, Mu F, Mao H, et al · · 2026 · PMID 41981677 · DOI 10.1186/s12967-026-08077-2
2. Neoadjuvant, Adjuvant and Perioperative Treatment in Early-Stage Non-Small Cell Lung Cancer (NSCLC) with Actionable Genomic Alterations: Current Landscape and Future Perspectives.
   Koutoukoglou P, Mountzios G. · · 2026 · PMID 41681965 · DOI 10.3390/cancers18030493