OncoMatch/Clinical Trials/NCT05341583
Ensartinib as Adjuvant Treatment in Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer
Is NCT05341583 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Ensartinib for non-small cell lung cancer.
Treatment: Ensartinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ALK positive
Disease stage
Required: Stage IB, IIA, IIB, IIIA, IIIB(T3N2M0)
Patients must be classified post-operatively as Stage IB-IIIB(T3N2M0) on the basis of pathologic criteria after complete surgical resection(R0).
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: platinum based chemotherapy for adjuvant therapy
Prior treatment with other anti-cancer treatments for NSCLC including chemotherapy, radiotherapy, targeted therapy (such as small molecule tyrosine kinase inhibitors targeting EGFR, VEGFR or other pathways, monoclonal antibodies, etc.), immunotherapy, investigational therapy, etc. but except platinum based chemotherapy for adjuvant therapy.
Cannot have received: radiotherapy
Prior treatment with other anti-cancer treatments for NSCLC including chemotherapy, radiotherapy, targeted therapy (such as small molecule tyrosine kinase inhibitors targeting EGFR, VEGFR or other pathways, monoclonal antibodies, etc.), immunotherapy, investigational therapy, etc. but except platinum based chemotherapy for adjuvant therapy.
Cannot have received: targeted therapy
Prior treatment with other anti-cancer treatments for NSCLC including chemotherapy, radiotherapy, targeted therapy (such as small molecule tyrosine kinase inhibitors targeting EGFR, VEGFR or other pathways, monoclonal antibodies, etc.), immunotherapy, investigational therapy, etc. but except platinum based chemotherapy for adjuvant therapy.
Cannot have received: immunotherapy
Prior treatment with other anti-cancer treatments for NSCLC including chemotherapy, radiotherapy, targeted therapy (such as small molecule tyrosine kinase inhibitors targeting EGFR, VEGFR or other pathways, monoclonal antibodies, etc.), immunotherapy, investigational therapy, etc. but except platinum based chemotherapy for adjuvant therapy.
Cannot have received: investigational therapy
Prior treatment with other anti-cancer treatments for NSCLC including chemotherapy, radiotherapy, targeted therapy (such as small molecule tyrosine kinase inhibitors targeting EGFR, VEGFR or other pathways, monoclonal antibodies, etc.), immunotherapy, investigational therapy, etc. but except platinum based chemotherapy for adjuvant therapy.
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5 x 10^9/L, Platelets ≥ 100 x 10^9/L, hemoglobin ≥9g/dL
Kidney function
Creatinine≤ 1.5 x institutional upper limit of normal, if not, Creatinine Clearance ≥ 50 ml/min
Liver function
Total bilirubin≤ 1.5 x institutional upper limit of normal, AST and ALT≤ 2.5 x institutional upper limit of normal
The laboratory test values should meet the following requirements: 1. Absolute neutrophil count ≥ 1.5 x 10^9/L , Platelets ≥ 100 x 10^9/L ，hemoglobin ≥9g/dL 2. Total bilirubin≤ 1.5 x institutional upper limit of normal,AST and ALT≤ 2.5 x institutional upper limit of normal 3. Creatinine≤ 1.5 x institutional upper limit of normal ,if not, Creatinine Clearance ≥ 50 ml/min 4. International normalized ratio (INR) and prothrombin time ≤1.5 x institutional upper limit of normal; and activated partial thromboplastin time (aPTT) ≤1.5 x institutional upper limit of normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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