RecruitingPhase 2NCT07322783

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

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


Sponsor

Qingdao Central Hospital

Enrollment

60 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two targeted drugs — osimertinib and savolitinib — for people with advanced non-small cell lung cancer (NSCLC) that has become resistant to prior treatments. The trial focuses on patients whose tumors have a low level of a gene amplification called MET, which may be driving their cancer's resistance. **You may be eligible if...** - You have advanced or metastatic NSCLC that has stopped responding to osimertinib, chemotherapy-immunotherapy, or anti-angiogenesis therapy - Your tumor has low MET amplification (fewer than 5 copies by FISH testing) - You are 18 or older and in reasonably good health - You have measurable tumor on imaging - Your kidneys, liver, and blood counts are functioning adequately **You may NOT be eligible if...** - You have significant heart rhythm problems or a prolonged QT interval on your electrocardiogram (ECG) - You have another serious uncontrolled illness - You are pregnant or not willing to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG• Drug: Savolitinib • Drug: Osimertinib Mesylate Tablets

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.


Locations(1)

Qingdao Central Hospital

Qingdao, China

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NCT07322783


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