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

StatusRecruiting
PhasePhase 2
Started2022-05-01
View on ClinicalTrials.gov ↗

Amendment history

2023-10-06
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-02→confirmed 2022-05-01
Study sitesdetails revised at 1 of 1 site
2022-02-06
minor
Original filing
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 chemotherapy.
Trial Details
NCT Number NCT05241028
Lead Sponsor Hebei Medical University Fourth Hospital
Conditions Non-small Cell Lung Cancer
Enrollment 80 participants
Start Date 2022-05-01
Primary Completion 2027-02 (estimated)
Study Completion 2029-02 (estimated)
Updated on ClinicalTrials.gov 2023-10-10