Ensartinib as Adjuvant Treatment in Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer

Recruiting Phase 3 Interventional Study
Non-small Cell Lung Cancer
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
202 (estimated)
Sponsor
Betta Pharmaceuticals Co., Ltd. · Industry
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About This Trial

This double-blind, randomized, placebo-controlled, multicenter, Phase III study is designed to evaluate the efficacy and safety of ensatinib compared with placebo as adjuvant treatment in ALK positive stage II-IIIB non-small cell lung cancer after surgical resection with or without chemotherapy.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Histologically confirmed diagnosis of primary non-small cell carcinoma of the lung. * Patients must be classified post-operatively as Stage IB-IIIB(T3N2M0) on the basis of pathologic criteria after complete surgical resection(R0). * Complete recovery from surgery and standard …
Contacts

Chang Li Wang, Ph.D

86-22-23340123

wangchangli@tjmuch.com

CONTACT