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NOT YET RECRUITING
NCT05186506
PHASE2

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

Sponsor: Sichuan University

View on ClinicalTrials.gov

Summary

This randomized, active-controlled, multicenter, open-label, Phase II study is designed to evaluate the efficacy and safety of ensatinib compared with Platinum-Based Chemotherapy as adjuvant treatment in ALK fusion positive II-IIIA stage non-small cell lung cancer after surgical resection

Official title: A Phase II, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Ensatinib Versus Platinum-Based Chemotherapy as Adjuvant Treatment for Stage II-IIIA ALK -Positive Non-Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - 73 Years

Study Type

INTERVENTIONAL

Enrollment

152

Start Date

2022-01-01

Completion Date

2028-12-20

Last Updated

2022-01-11

Healthy Volunteers

No

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.