Clinical trial · Interventional
Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer
Adjuvant Therapy of Ensatinib in Patients With Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer: a Prospective, Multi-center, Single-arm Exploratory Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ensartinib | Drug | Ensartinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ensartinib
- description
- Ensartinib 225mg oral daily for 3 years or until recurrence of the disease or intolerable toxicity
- interventionNames
- Drug: Ensartinib
Primary outcomes (1)
- measure
- 3-year disease free survival rate (DFSR)
- timeFrame
- 3 years
- description
- Defined as the percentage of patients alive and disease free at 3 years
Secondary outcomes (4)
- measure
- 5-year overall survival rate
- timeFrame
- 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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 receiving adjuvant ensatinib treatment. (When starting the study treatment, the patient must have recovered from all toxicities greater than CTCAE Grade 1 caused by the previous treatment, except for hair loss and Grade 2 neuropathy related to previous platinum-based treatments). * Clinical examinations before treatment report no signs of disease recurrance. * With enough tumor histology specimens (non-cytology) for molecular marker analysis. * 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. * Liver Function: TBil ≤2xULN; ALT and AST ≤2.5xULN; * Renal Function: Cr ≤1.5xULN, and Ccr ≥60ml/min; * Signed inform consent form by patient or his/her legal representative. * Comply with study protocol and procedure, and be able to take oral medication. * Female patients of childbearing potential must have a negative urine pregnancy test within 7 days before study treatment. * Eligible patients of reproductive potential (both sexes) must agree to use a reliable method of birth control before enrollment, during the study period and for at least 8 weeks after their last dose of study therapy. Exclusion Criteria: * Having targeted medication therapy (including tyrosine kinase inhibitor or monoclonal antibody) and experimental therapy for NSCLC in the past. * Having local radiotherapy of NSCLC. * Known allergy to Ensatinib or any of the ingredients in this product. * Previously suffering from interstitial lung disease, drug-induced interstitial disease, radiation pneumonia that requires hormone therapy, or any clinically evidenced active interstitial lung disease; CT scan at baseline revealed the presence of idiopathic pulmonary fibrosis. * Any unstable systemic disease, including: active infection, uncontrolled high blood pressure, unstable angina pectoris, angina pectoris that started within the last 3 months, congestive heart failure (≥ New York Heart Association \[NYHA\] II Grade), myocardial infarction (6 months before enrollment), severe arrhythmia requiring medical treatment; liver, kidney or metabolic diseases. * Women who are pregnant or breastfeeding. * Having history of neurological or psychiatric disorders, including epilepsy or dementia. * Other conditions investigators evaluate that patient is not eligible to this study.
References
Publications (0)
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