Osimertinib + Savolitinib Phase 3 NSCLC Trial Reaches Primary Completion

A Phase 3 clinical trial investigating the combination of osimertinib and savolitinib for patients with advanced non-small cell lung cancer (NSCLC) with MET amplification reached primary completion on 2025-08-22. This study compares the investigational combination therapy against standard platinum-based chemotherapy.

Background

Osimertinib (Tagrisso) is an established treatment for certain types of non-small cell lung cancer (NSCLC). This study specifically targets patients with locally advanced or metastatic NSCLC characterized by MET amplification, following failure of first-line EGFR inhibitor therapy. The trial explores the potential of combining osimertinib with savolitinib in this challenging patient population.

Trial design

The Phase 3 study (NCT05015608), titled "Study on Savolitinib Combined With Osimertinib in Treatment of Advanced NSCLC With MET Amplification," enrolled 216 participants. Participants had locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET amplification, after failure of first-line EGFR inhibitor therapy. The trial's intervention arms include savolitinib + osimertinib and pemetrexed + cisplatin /carboplatin, aiming to assess the experimental combination against a standard chemotherapy regimen.

What this means

Primary completion of this Phase 3 trial indicates that data collection for the primary endpoint is concluded. This is a significant milestone, but it does not mean results are available or analyzed. Clinicians and researchers must await the full analysis and reporting of the trial's outcomes to understand the potential role of savolitinib combined with osimertinib in treating advanced NSCLC with MET amplification after failure of first-line EGFR inhibitor therapy. No efficacy or safety results have been reported at this stage.

Source

Information regarding the primary completion of this clinical trial was obtained from ClinicalTrials.gov. The update for the study NCT05015608, titled "Study on Savolitinib Combined With Osimertinib in Treatment of Advanced NSCLC With MET Amplification," was posted on 2025-08-22 on clinicaltrials.gov.