Almonertinib Versus Osimertinib in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases

Sponsor
Shanghai Chest Hospital
Study ID
NCT04870190
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Almonertinib — DRUG
    Almonertinib will be administered orally at a dose of 165 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 controlled, double-blind clinical trial. The study is designed to evaluate the efficacy and safety of high-dose Almonertinib versus Osimertinib in the second-line treatment of patients with EGFR mutations in advanced NSCLC with brain metastases.

Key Dates

Start date
Jun 1, 2021
Status verified
Apr 2021
Primary completion
Jun 1, 2024
Completion
Jun 1, 2024

Study Design

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

Arms

  • Experimental: Almonertinib
    Almonertinib will be administered orally at a dose of 165 mg per time, Q.D.
  • Active Comparator: Osimertinib
    Osimertinib will be administered orally at a dose of 80 mg per time, Q.D.

Primary Outcome Measure

Intracranial progression-free survival (IPFS) in patients with advanced NSCLC with brain metastases treated with high-dose Almonertinib versus Osimertinib in second-line treatment with positive EGFR T790M mutation. [ Time Frame: 36 months ]

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