Aumolertinib Versus Osimertinib As First-line Therapy for Patients with EGFR Mutated Locally Advanced or Metastatic Non-small-cell Lung Cancer
NCT06752408 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 316
Last updated 2024-12-30
Summary
This is a multicenter, randomized, open-label, non-inferiority real world study. The study is designed to evaluate the efficacy and safety of Aumolertinib versus Osimertinib in the first-line treatment of patients with EGFR mutated locally advanced or metastatic non-small-cell lung cancer.
Conditions
- Non Small Cell Lung Cancer
Interventions
- DRUG
-
Aumolertinib
Aumolertinib will be administered orally at a dose of 110 mg per time, Q.D.
- DRUG
-
Osimertinib will be administered orally at a dose of 80 mg per time, Q.D.
Sponsors & Collaborators
-
Peking University People's Hospital
collaborator OTHER -
China-Japan Friendship Hospital
collaborator OTHER -
Peking Union Medical College Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-17
- Primary Completion
- 2027-01-16
- Completion
- 2028-01-16
Countries
- China
Study Locations
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