Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT05009836

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

A Multicenter, Randomized, Double-blind, Phase III Clinical Study to Evaluate the Efficacy and Safety of Savolitinib + Osimertinib Versus Placebo + Osimertinib as the First Line Therapy for Patients With EGFRm+/MET+ NSCLC

Status
Active Not Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
320 (estimated)
Sponsor
Hutchison Medipharma Limited · Industry
Sex
All
Age
28 Years
Healthy volunteers
Not accepted

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

Detailed description

A Multicenter, Randomized, Double-blind, Phase III Clinical Study to Evaluate the Efficacy and Safety of Savolitinib Combined with Osimertinib versus Placebo Combined with Osimertinib as the First-line Therapy for Patients with EGFRm+/MET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer

Conditions

Interventions

TypeNameDescription
DRUGSavolitinibSubjects 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.
DRUGPlaceboSubjects will receive placebo orally once per day (QD) + Osimertinib orally QD,21day cycles (every 3 weeks) until disease progression, death, adverse

Timeline

Start date
2021-09-06
Primary completion
2026-08-30
Completion
2026-08-30
First posted
2021-08-18
Last updated
2025-08-29

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05009836. Inclusion in this directory is not an endorsement.