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
- gumarontinib — DRUG300 mg , qd ,po, expect 6 months.
- third-generation EGFR-TKI (Osimertinib, Almonertinib or Furmonertinib) — DRUGAccording to the actual situation of patients. Take as recommended, expect 6 months.
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-TKIPatients 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
- Jie Wang, PhD13910704669
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