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Clinical Trial 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


Clinical Trial Description

Participants in the experimental arm will receive Ensatinib at 225 mg orally once a day (QD) taken with food for 2 years. Participants in the control arm will receive one of the protocol specified platinum based chemotherapy regimens for 4 cycles. Treatments will continue until disease recurrence, meeting one of treatment discontinuation criteria (eg, patient decision, adverse event, pregnancy), or achieving a maximum treatment duration of 2 years. At the time of disease recurrence, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05186506
Study type Interventional
Source Sichuan University
Contact You Lu, MD
Phone +8618980601763
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date January 1, 2022
Completion date December 20, 2028

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