ASK120067 Versus Gefitinib as First-line Treatment for EGFRm Locally Advanced or Metastatic NSCLC

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

337

Participants

Timeline

Start Date

July 23, 2019

Primary Completion Date

March 31, 2024

Study Completion Date

September 30, 2026

Conditions
Locally Advanced or Metastatic NSCLC
Interventions
DRUG

ASK120067

ASK120067 (80 mg orally twice daily) . 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 according to RECIST 1.1, 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 according to RECIST 1.1, as judged by the Investigator, and in the absence of discontinuation criteria.

DRUG

Gefitinib

Gefitinib (250 mg orally, once daily) , 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 acording to RECIST 1.1, as judged by the Investigator, and in the absence of discontinuation criteria.

DRUG

Placebo ASK120067

Placebo ASK120067orally 80mg twice daily . 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 according to RECIST 1.1, as judged by the Investigator, and in the absence of discontinuation criteria.

Trial Locations (3)

100021

Chinese Academy of Medical Sciences, Beijing

101149

Beijing Chest Hospital,Capital Medical University, Beijing

Unknown

Jiangsu Cancer Hospital, Nanjing

All Listed Sponsors
lead

Jiangsu Aosaikang Pharmaceutical Co., Ltd.

INDUSTRY