NCT05015608

Study on Savolitinib Combined With Osimertinib in Treatment of Advanced NSCLC With MET Amplification

Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Savolitinib + Osimertinib Versus Pemetrexed + Platinum in Treatment of Patients With NSCLC With MET Amplification

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will look at how effective the study drug(Savolitinib combined with Osimertinib) versus Pemetrexed combined with platinum in treatment of patients with locally advanced or metastatic NSCLC with MET amplification after failure of the first-line EGFR inhibitor therapy.

Detailed description

This is a multicenter, randomized, controlled, open, phase III clinical study to evaluate the clinical efficacy and safety of Savolitinib combined with Osimertinib in treatment of patients with locally advanced or metastatic NSCLC with MET amplification after failure of EGFR inhibitor therapy.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Savolitinib + Osimertinib	Subjects will receive Savolitinib orally once per day (QD) + Osimertinib orally QD,21day cycles (every 3 weeks) until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
DRUG	Pemetrexed + Cisplatin /Carboplatin	Pemetrexed combined with platinumon on Day 1 of 21day cycles (every 3 weeks)

Timeline

• Start date: 2021-11-22
• Primary completion: 2025-12-15
• Completion: 2025-12-30
• First posted: 2021-08-20
• Last updated: 2025-05-23

Locations

1 site across 1 country: China