At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Abivertinib Maleate Capsules, Placebo Gefitinib Tablets, and 2 other interventions for Advanced Non-small Cell Lung Cancer. Targeting 406 participants across 1 site.
Detailed 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
Study Details
Timeline
Interventions
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.
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.
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.
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.