NCT04870190

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

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: a Multicenter, Randomized Controlled, Double-Blind Clinical Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 232 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a multicenter, randomized controlled, double-blind clinical study which will recruit about 232 patients in China. 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. Target Patient Population:Age 18 years or older with histologically or cytologically proven advanced NSCLC with brain parenchymal (BM) metastases.The patient was laboratory confirmed to be EGFR T790M mutation positive at or after progression of 1/2 generation EGFR-TKI therapy. Test Drug, Dosage and Medication Regimen:Almonertinib will be administered orally at a dose of 165 mg per time, Q.D.If a patient cannot tolerate a dose of 165mg due to adverse reactions, when the adverse reactions restore to level 1 (CTCAE 5.0) or below, the dosage could be adjusted to 110mg per day, Q.D. Osimertinib will be administered orally at a dose of 80 mg per time, Q.D. If a patient cannot tolerate a dose of 40mg due to adverse reactions, when the adverse reactions restore to level 1 (CTCAE 5.0) or below, the dosage could be adjusted to 40mg per day, Q.D.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Almonertinib	Almonertinib will be administered orally at a dose of 165 mg per time, Q.D.
DRUG	Osimertinib	Osimertinib will be administered orally at a dose of 80 mg per time, Q.D.

Timeline

• Start date: 2021-06-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2021-05-03
• Last updated: 2021-05-03