NCT06452433

Gumarontinib Combined With 3rd EGFR-TKI in Patients With Non-small Cell Lung Cancer.

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 91 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	gumarontinib	300 mg , qd ,po, expect 6 months.
DRUG	third-generation EGFR-TKI (Osimertinib, Almonertinib or Furmonertinib)	According to the actual situation of patients. Take as recommended, expect 6 months.

Timeline

• Start date: 2024-06-01
• Primary completion: 2027-12-12
• Completion: 2028-02-02
• First posted: 2024-06-11
• Last updated: 2024-06-11