Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLETEO)

PHASE3RecruitingINTERVENTIONAL
Enrollment

680

Participants

Timeline

Start Date

June 8, 2022

Primary Completion Date

May 31, 2025

Study Completion Date

December 31, 2027

Conditions
NSCLCEGFR Activating Mutation
Interventions
DRUG

TY-9591

"The dose of TY-9591 is 160 mg 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, as judged by the Investigator, and in the absence of discontinuation criteria."

DRUG

placebo Osimertinib

"The dose of placebo Osimertinib is 80 mg 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, as judged by the Investigator, and in the absence of discontinuation criteria."

DRUG

Osimertinib

"The dose of Osimertinib is 80 mg 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, as judged by the Investigator, and in the absence of discontinuation criteria."

DRUG

placebo TY-9591

"The dose of placebo TY-9591 is 160 mg 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, as judged by the Investigator, and in the absence of discontinuation criteria."

Trial Locations (2)

201203

RECRUITING

Shanghai Chest Hospital, Shanghai

410013

RECRUITING

Hunan Provincial Tumor Hospital, Changsha

All Listed Sponsors
lead

TYK Medicines, Inc

INDUSTRY