Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452433
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-06-05
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:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
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?:
None