Actively Recruiting
Osimertinib Combined With Savolitinib in the Treatment of NSCLC With Low Copy Number MET Amplification
Led by Qingdao Central Hospital · Updated on 2026-01-07
60
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Osimertinib Combined With Savolitinib in the Treatment of NSCLC With Low Copy Number MET Amplification
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed incurable advanced or metastatic non-small cell lung cancer resistant to osimertinib, chemo-immunotherapy, or anti-angiogenesis treatments
- At least one measurable tumor lesion according to RECIST 1.1 criteria
- MET amplification copy number below 5 by FISH testing
- Male or female patients aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Estimated overall survival of 3 months or more
- Adequate blood, bone marrow, kidney, and liver function
- Recovery from all prior anticancer therapy side effects to grade 2 or less, except for controlled grade 2 nausea/vomiting or diarrhea
- Willingness to use effective contraception during treatment and for at least three months after last dose if of childbearing potential
- Ability to understand and willing to sign informed consent
- Willingness and ability to comply with study procedures and follow-up
You will not qualify if you...
- Resting QTc interval over 470 milliseconds or significant heart rhythm abnormalities
- Family history of congenital long QT syndrome
- Serious or uncontrolled systemic diseases including active hepatitis B, hepatitis C, or HIV infection
- Uncontrolled high blood pressure requiring two or more medications
- Angina pectoris within 3 months before study or unstable angina
- Heart failure of New York Heart Association class II or higher
- Heart attack within 6 months prior to enrollment
- Severe arrhythmias requiring medical attention
- Severe liver, kidney, gastrointestinal, or metabolic diseases
- Inability to take oral medications
- Other malignancies requiring treatment except certain effectively treated skin or cervical cancers
- Pregnancy or lactation
- Known allergies or intolerance to osimertinib or savolitinib
- Any condition judged by the investigator to make participation unsafe or unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Qingdao Central Hospital
Qingdao, China, 266042
Actively Recruiting
Research Team
Y
youxin Ji, md, phD
CONTACT
K
keke nie
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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