Aumolertinib Versus Osimertinib As First-line Therapy for Patients with EGFR Mutated Locally Advanced or Metastatic Non-small-cell Lung Cancer

Sponsor
Peking Union Medical College Hospital
Study ID
NCT06752408
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Aumolertinib — DRUG
    Aumolertinib will be administered orally at a dose of 110 mg per time, Q.D.
  • Osimertinib — DRUG
    Osimertinib will be administered orally at a dose of 80 mg per time, Q.D.

Study Details

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.

Key Dates

Start date
Dec 17, 2024
Status verified
Dec 2024
Primary completion
Jan 16, 2027
Completion
Jan 16, 2028

Study Design

Enrollment
316 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Aumolertinib
  • Active Comparator: Osimertinib

Primary Outcome Measure

Progression Free Survival (PFS) as Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 3 years ]

Central Contacts

Related Studies