OncoMatch/Clinical Trials/NCT05241028
Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer
Is NCT05241028 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Ensartinib for non-small cell lung cancer.
Treatment: Ensartinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ALK fusion
Disease stage
Required: Stage IB, IIA, IIB, IIIA
Completely resected pathological stage IB-IIIA NSCLC
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: surgery — curative
Completely resected pathological stage IB-IIIA NSCLC
Cannot have received: targeted therapy
Having targeted medication therapy (including tyrosine kinase inhibitor or monoclonal antibody) and experimental therapy for NSCLC in the past
Cannot have received: radiation therapy
Having local radiotherapy of NSCLC
Lab requirements
Blood counts
hemoglobin concentration ≥ 100 g/l (permit to maintain hematologic criteria by blood transfusion); absolute neutrophil count (anc) ≥1.5×10^9/l; platelet count ≥100×10^9/l
Kidney function
cr ≤1.5xuln, and ccr ≥60ml/min
Liver function
tbil ≤2xuln; alt and ast ≤2.5xuln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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