Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer

Recruiting Phase 2 Interventional Study
Non-small Cell Lung Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. 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 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
Hebei Medical University Fourth Hospital · Other
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About This Trial
This is a prospective, multi-center, single-arm, phase 2 study aiming to assess the efficacy and safety of adjuvant use of Ensartinib in stage IB-IIIA non-small cell lung cancer (NSCLC) with positive ALK-fusion. Enrolled patients will take Ensatinib for 3 years or until recurrence of the disease or intolerable toxicity, following complete tumour resection with or without adjuvant standard chemothe…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Completely resected pathological stage IB-IIIA NSCLC with ALK-fusion positive (confirmed by FISH, IHC or NGS). * Males or females aged ≥18 years, ≤75 years. * ECOG performance status 0-2. * Completely recovered from surgery or standard postoperative chemotherapy before receivi…
Contacts

Junfeng Liu, PhD

13931152296

liujf@hbmu.edu

CONTACT