A Study to Evaluate Safety and Efficacy of HS-10296 as First-Line Treatment in Patients

PHASE3UnknownINTERVENTIONAL
Enrollment

429

Participants

Timeline

Start Date

February 1, 2019

Primary Completion Date

January 15, 2021

Study Completion Date

June 30, 2023

Conditions
Non Small Cell Lung Cancer
Interventions
DRUG

HS-10296

Drug: HS-10296 110 mg/55 mg + placebo The initial dose of HS-10296 110 mg once daily can be reduced to 55 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

Gefitinib

Drug: Gefitinib 250 mg + placebo The initial dose of 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.

Trial Locations (1)

Unknown

Beijing Cancer Hospital, Beijing

All Listed Sponsors
lead

Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY

NCT03849768 - A Study to Evaluate Safety and Efficacy of HS-10296 as First-Line Treatment in Patients | Biotech Hunter | Biotech Hunter