NCT03856697

Abivertinib Maleate Versus Geifitinib in Patients With Advanced Non-small Cell Lung Cancer With Sensitive EGFR Mutation

A Randomized Controlled, Double-blind, Multicenter, Phase III Clinical Study to Compare Efficacy and Safety of Abivertinib Maleate Versus First-line Standard Therapy EGFR-TKI in Patients With Advanced NSCLC With Sensitive EGFR Mutation

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 406 (estimated)
• Sponsor: Hangzhou ACEA Pharmaceutical Research Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To compare efficacy and safety of Abivertinib maleate alone versus standard first-line EGFR-TKIs for the treatment of patients with advanced non-small cell lung cancer with sensitive EGFR mutation

Detailed description

This is a randomized controlled, double-blind, multicenter, phase III clinical study to compare efficacy and safety of Abivertinib maleate versus first-line standard therapy EGFR-TKI for the treatment of patients with advanced non-small cell lung cancer with sensitive EGFR mutation

Conditions

• Advanced Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Abivertinib Maleate Capsules	patients receive the test drug (Abivertinib maleate Capsules) since the first day of cycle 1. One cycle is defined as 21 days. The patient shall take the study drugs twice a day. The first dose is 3 capsules, and the second dose is 3 capsules. The drugs should be administered with water before or after meals.
DRUG	Placebo Gefitinib Tablets	patients receive the test drug (Placebo Gefitinib Tablets) since the first day of cycle 1. One cycle is defined as 21 days. The patient shall take the study drugs twice a day. The first dose is 1 tablet. The drugs should be administered with water before or after meals.
DRUG	Gefitinib Tablets	patients receive the control drug (Gefitinib Tablets) since the first day of cycle 1. One cycle is defined as 21 days. The patient shall take the study drugs twice a day. The first dose is 1 tablet. The drugs should be administered with water before or after meals.
DRUG	Placebo Abivertinib Maleate Capsules	patients receive the control drug (Placebo Abivertinib Maleate Capsules) since the first day of cycle 1. One cycle is defined as 21 days. The patient shall take the study drugs twice a day. The first dose is 3 capsules, and the second dose is 3 capsules. The drugs should be administered with water before or after meals.

Timeline

• Start date: 2019-03-01
• Primary completion: 2022-03-01
• Completion: 2024-03-01
• First posted: 2019-02-27
• Last updated: 2019-02-27

Locations

1 site across 1 country: China