Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
Study NCT ID:
NCT07156604
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-05
First Post:
2025-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vebreltinib for Neoadjuvant in METex 14 Skipping Mutant Stage IIA-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)
Sponsor:
Fudan University
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: