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
| Type | Name | Description |
|---|---|---|
| DRUG | Savolitinib | 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 | Placebo | Subjects 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.