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Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC

NCT05009836 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 412

Last updated 2026-06-10

No results posted yet for this study

Summary

A Phase III Clinical Study on Savolitinib Combined with Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer

Conditions

Interventions

DRUG

Savolitinib

Subjects will receive Savolitinib 600 mg or 400 mg daily (including 600/400 mg QD or 300/200 mg BID) orally, 21day cycles (every 3 weeks) until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.

DRUG

Placebo

Subjects will receive Placebo 600 mg or 400 mg daily (including 600/400 mg QD or 300/200 mg BID) orally, 21day cycles (every 3 weeks) until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.

Sponsors & Collaborators

  • Hutchison Medipharma Limited

    lead INDUSTRY

Principal Investigators

  • Yilong Wu, MD · Guangdong Provincial People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
28 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-06
Primary Completion
2028-05-30
Completion
2028-05-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05009836 on ClinicalTrials.gov