429
Participants
Start Date
February 1, 2019
Primary Completion Date
January 15, 2021
Study Completion Date
June 30, 2023
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.
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.
Beijing Cancer Hospital, Beijing
Lead Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
INDUSTRY