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 (Jun 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
Treatments studied
Targeted therapy
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)
Demographics
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.
Frequently asked questions
Is NCT05241028 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior targeted therapy, radiation therapy disqualifies patients from enrollment.
Does this trial require ALK?
Yes, ALK fusion is a required biomarker for enrollment.
What disease stage is eligible?
Stage IB or IIA or IIB or IIIA is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages