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

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.

Timeline

Start

2021-11-22

Primary completion

2025-08-22

Completion

2025-08-22

Outcome

Met primary endpoint

paper Median PFS was significantly prolonged with savolitinib-osimertinib versus chemotherapy PMID 41544643 ↗

paper hazard ratio 0·34 [0·21-0·56]; p<0·0001 PMID 41544643 ↗

release “Primary endpoint met in SACHI China Phase III interim analysis for 2L EGFRm NSCLC patients with MET amplification (NCT05015608).” hutch-med.com ↗

release “SACHI China Phase III trial met the primary endpoint of PFS during its interim analysis towards the end of 2024” hutch-med.com ↗

release “SACHI had met the pre-defined primary endpoint of progression-free survival (PFS) in a planned interim analysis.” hutch-med.com ↗

release “In January 2025, the Independent Data Monitoring Committee (IDMC) of SACHI considered that the study had met the pre-defined primary endpoint of progression-free survival” hutch-med.com ↗

release “SACHI: The SACHI China Phase III trial met the primary endpoint of progression free survival (PFS) during its interim analysis towards the end of 2024.” hutch-med.com ↗

release “IDMC) of SACHI has considered that the study has met the pre-defined primary endpoint of PFS in a planned interim analysis” hutch-med.com ↗

Publications

• Lu S, Wang J, Yang N, Lv D, Chen L, Wu L, Li X, Sun L, Yu Y, Jin B, Yang L, Guo Y, Xu H, Yi T, Zeng A, Dong X, Chen J, Wang Z, Niu H, Cheng Y, Pan P, Deng P, Pan H, Min X, Bai J, Liu L, Zhang T, Li J, Fan S, Shi MM, Mok T, Su W; SACHI Study Group. Savolitinib plus osimertinib versus chemotherapy for advanced, EGFR mutation-positive, MET-amplified non-small-cell lung cancer in China (SACHI): interim analysis of a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2026 Jan 24;407(10526):375-387. doi: 10.1016/S0140-6736(25)01811-2. Epub 2026 Jan 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Carboplatin	Small molecule	—	Intravenous
Comparator	Cisplatin	Other / unclassified	—	Intravenous
Subject	Osimertinib	Small molecule	—	Oral
Comparator	Pemetrexed	Small molecule	—	Intravenous
Subject	Savolitinib	Small molecule	—	Oral

Indications