Actively Recruiting
Osimertinib Combined With Savolitinib in Treating EGFR Mutated Osimertinib Resistant NSCLC With Low Copy Number MET Amplification
Led by Qingdao Central Hospital · Updated on 2026-01-07
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of osimertinib and savolitinib for treating patients with advanced non-small cell lung cancer (NSCLC) who have developed resistance to osimertinib and have low copy number MET amplification. This phase 2, open-label, single-arm, multicenter study aims to explore the safety and effectiveness of this combination in patients whose cancer has not responded to prior therapies including osimertinib, chemotherapy, immunotherapy, or anti-angiogenesis treatments. Low copy number MET amplification is defined as a MET amplification below 5 copies tested by next-generation sequencing or fluorescent in situ hybridization. Participants will receive osimertinib mesylate tablets at 80 mg orally once daily combined with savolitinib dosed based on body weight—400 mg daily for those under 60 kg and 600 mg daily for those over 60 kg. The treatment continues until disease progression or intolerable side effects occur, with possible dose reductions of savolitinib from 600 mg to 400 mg, and from 400 mg to 200 mg if needed. This study does not include placebo or comparator arms. During the study, patients will be monitored for their overall response rate assessed at 2 months, which measures the percentage of patients showing tumor shrinkage or disappearance. Researchers will also assess progression-free survival for up to 24 months, tracking the time from enrollment until disease progression or death. Patients will undergo regular evaluations to monitor safety, side effects, and treatment effectiveness. The total participation duration depends on individual response and tolerability to the treatment.
CONDITIONS
Brief 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 advanced or metastatic non-small cell lung cancer resistant to osimertinib, chemotherapy, immunotherapy, or anti-angiogenesis.
- At least one measurable tumor lesion according to RECIST 1.1 criteria.
- MET amplification copy number below 5 confirmed by FISH.
- Male or female patients aged 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2.
- Estimated overall survival of at least 3 months.
- Adequate blood, bone marrow, kidney, and liver functions.
- Recovered from prior treatment toxicities to grade 2 or less, except for certain manageable nausea or diarrhea.
- Willing to use effective contraception during treatment and for at least 3 months after last dose.
- Able to understand and willing to sign informed consent.
- Willing and able to comply with study procedures and follow-up.
You will not qualify if you...
- Resting QTc interval over 470 milliseconds or significant ECG abnormalities such as heart block or bundle branch block.
- Serious or uncontrolled systemic diseases including active infections like hepatitis B, hepatitis C, or HIV.
- Uncontrolled hypertension requiring multiple medications.
- Recent unstable angina, congestive heart failure (NYHA class II or higher), or recent heart attack within 6 months.
- Severe liver, kidney, gastrointestinal, or metabolic diseases.
- Inability to take study drugs as required.
- Other active cancers needing treatment, except certain effectively treated skin or cervical cancers.
- Pregnant or breastfeeding women.
- Allergies or intolerance to osimertinib or savolitinib.
- Any other condition making participation unsuitable as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or intolerable toxicities
Participants receive osimertinib 80 mg orally daily combined with savolitinib (400-600 mg daily depending on body weight) until disease progression or intolerable toxicities.
Regular visits as per protocol to monitor treatment and safety
Trial Site Locations
Total: 1 location
1
Qingdao Central Hospital
Qingdao, China, 266042
Actively Recruiting
Research Team
Y
youxin Ji, md, phD
K
keke nie
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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