Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-31 @ 7:14 PM
Study NCT ID:
NCT06452433
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gumarontinib Combined With 3rd EGFR-TKI in Patients With Non-small Cell Lung Cancer.
Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Organization:
Study Overview
Official Title:
Gumarontinib Combined With Third-generation EGFR-TKI in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer With MET Amplification Following EGFR-TKI Treatment Failure.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 study evaluated the efficacy and safety of gumarontinib combined with third-generation EGFR-TKI in the treatment of locally advanced or metastatic NSCLC with MET amplification after first-line EGFR-TKI failure, without limiting the type of third-generation EGFR-TKI. The study was divided into 2 cohorts: Cohort 1 included patients with MET amplification after third-generation EGFR-TKI first-line therapy resistance, and cohort 2 included patients with MET amplification after first-generation EGFR-TKI first-line therapy resistance.
Detailed Description:
This study evaluated the efficacy and safety of gumarontinib combined with third-generation EGFR-TKI in the treatment of locally advanced or metastatic NSCLC with MET amplification after first-line EGFR-TKI failure, without limiting the type of third-generation EGFR-TKI. The study was divided into 2 cohorts: Cohort 1 included patients with MET amplification after third-generation EGFR-TKI first-line therapy resistance, and cohort 2 included patients with MET amplification after first-generation EGFR-TKI first-line therapy resistance. Patients will receive the combination until disease progression or intolerable toxicity. A total of 91 patients who met the inclusion and exclusion criteria were included in the study. The primary endpoint was ORR.
Study Oversight
Has Oversight DMC:
None
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?: