Osimertinib Combined With Savolitinib in the Treatment of NSCLC With Low Copy Number MET Amplification

Sponsor
Qingdao Central Hospital
Study ID
NCT07322783
Phase
PHASE2
Status
Recruiting
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Conditions

  • EGFR Positive Non-small Cell Lung Cancer
  • MET Amplification

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • • Drug: Savolitinib • Drug: Osimertinib Mesylate Tablets — DRUG
    Osimertinib 80 mg oral daily, savolitinib 400-600 mg (400mg for body weight \<60 kg, 600 mg for body weight \>60 kg) until disease progression or intolerable toxicities. Dose reduction of savolitinib can be from 600 mg to 400 mg and 400 mg to 200 mg.

Study Details

Osimertinib combined with savolitinib in the treatment of EGFR mutated osimertinib resistant NSCLC with low copy number MET amplification There are unmet medical needs in patients who resist to to osimertinib; savolitinib plus osimertinib shows high response rate and prolong progression-free survival in high copy number MET amplification patients. This study is to explore the efficacy and safety of the combination of savolitinib and osimertinib in osimertinb resistant patients with low copy number MET amplification.

Key Dates

Start date
Jan 1, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Savolitinib plus osimertinib

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: the percentage of patients getting partial response and complete response, assessed at 2 month. ]

Central Contacts

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