NCT07322783

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Qingdao Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

his is an open-label, single-arm, multicenter, phase 2 study. Low copy number MET amplification is defined as MET amplification copy number below 5 tested with NGS or FISH. All patients were 3rd or more lines therapy that had resistant to osimertinib, chemo-immunotherapy or anti-angiogenesis. Osimertinib mesylate tablets (hereinafter referred to as osimertinib) is 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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-01-07
• Last updated: 2026-01-07

Locations

1 site across 1 country: China