Alflutinib Mesylate Versus Gefitinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLAG)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

358

Participants

Timeline

Start Date

May 30, 2019

Primary Completion Date

September 15, 2021

Study Completion Date

March 31, 2026

Conditions
Locally Advanced or Metastatic EGFR Sensitising Mutation Positive Non-small Cell Lung Cancer
Interventions
DRUG

Alflutinib Mesylate (AST2818) 80mg//40 mg+ placebo

"The initial dose of AST2818 80 mg once daily can be reduced to 40 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment.~Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria."

DRUG

Placebo Gefitinib 250 mg

The initial dose of Placebo Gefitinib 250 mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.

DRUG

Gefitinib 250 mg

"The initial dose of Gefitinib 250mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment.~Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria."

DRUG

Placebo AST2818 80mg//40 mg

The initial dose of Placebo AST2818 80 mg once daily can be reduced to Placebo AST2818 40 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.

Trial Locations (1)

Unknown

cancer hospital Chinese academy of medical sciences, Beijing

Sponsors
All Listed Sponsors
lead

Allist Pharmaceuticals, Inc.

INDUSTRY

NCT03787992 - Alflutinib Mesylate Versus Gefitinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLAG) | Biotech Hunter | Biotech Hunter