Osimertinib + Savolitinib NSCLC Trial Reaches Primary Completion

The Phase 3 study (NCT05015608) investigating savolitinib combined with osimertinib for the treatment of advanced non-small cell lung cancer (NSCLC) with MET amplification reached its primary completion on 2025-12-15. This trial aims to assess the efficacy of the combination therapy in patients who have progressed after first-line EGFR inhibitor therapy.

Background

Osimertinib (brand name Tagrisso) is an EGFR tyrosine kinase inhibitor widely used in the treatment of NSCLC. The current trial explores its combination with savolitinib, a MET inhibitor, targeting a specific subset of patients with locally advanced or metastatic NSCLC characterized by MET amplification. This patient population often faces limited treatment options after failure of initial EGFR inhibitor therapy, highlighting the need for new strategies.

Trial design

The study, titled "Study on Savolitinib Combined With Osimertinib in Treatment of Advanced NSCLC With MET Amplification" (NCT05015608), is a Phase 3, active-not-recruiting trial. It enrolled 250 participants diagnosed with Non-small Cell Lung Cancer. The trial compares the investigational arm of savolitinib + osimertinib against a control arm of pemetrexed + cisplatin /carboplatin. The primary objective is to evaluate the effectiveness of the combination therapy in patients with locally advanced or metastatic NSCLC with MET amplification following progression on first-line EGFR inhibitor therapy.

What this means

The primary completion of this Phase 3 trial signifies that all participants have completed the study's primary endpoint data collection. While specific results are not yet available, the completion of this stage is a critical milestone for the development of savolitinib combined with osimertinib. The data from this study will be crucial in determining the potential of this combination therapy as a new treatment option for patients with advanced NSCLC who have MET amplification and have failed prior EGFR inhibitor treatment.

Source

Information regarding the primary completion of the trial NCT05015608 was obtained from the ClinicalTrials.gov database. The record for the study, titled "Study on Savolitinib Combined With Osimertinib in Treatment of Advanced NSCLC With MET Amplification," indicates a primary completion date of 2025-12-15 and is available on clinicaltrials.gov.