A Study Comparing Ensatinib Versus Platinum-Based Chemotherapy as Adjuvant Treatment for Stage II-IIIA ALK -Positive Non-Small Cell Lung Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

152

Participants

Timeline

Start Date

January 1, 2022

Primary Completion Date

December 15, 2025

Study Completion Date

December 20, 2028

Conditions
ALK Fusion Protein ExpressionAdjuvant TherapyNon-Small Cell Lung Cancer
Interventions
DRUG

Ensatinib

225 mg administered once daily orally for two years.

DRUG

chemotherapy

"Pemetrexed : Participants will receive 500 mg/m\^2, day 1 , Q21D , until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.~Cisplatin :Participants will receive 75 mg/m\^2, day 1 , 21 days/cycle, Q21D , until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.~Paclitaxel: Participants will receive 175 mg/ m\^2, day 1 , 21 days/cycle, Q21D , until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.~carboplatin AUC= 5 mg/ mL/min, intravenously guttae, day 1 ,Q21D ,until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first."

Sponsors
All Listed Sponsors
collaborator

Betta Pharmaceuticals Co., Ltd.

INDUSTRY

lead

Sichuan University

OTHER