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

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT06452433
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 1, 2024
Status verified
Jun 2024
Primary completion
Dec 12, 2027
Completion
Feb 2, 2028

Study Design

Enrollment
91 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Gumarontinib combined with third-generation EGFR-TKI
    Patients were treated with Gumarontinib in combination with third-generation EGFR-TKI (Osmertinib,Almonertinib, Furmonertinib) oral therapy until disease progression or the onset of intolerable toxicity, treatment is expected to last 3-6 months.

Primary Outcome Measure

Objective response rate [ Time Frame: From initial medication to the date of first documented progression or end of medication. Assessed up to 6 months. ]

Central Contacts

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