Recruiting NCT05241028
Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ensartinib.
- Who it may be relevant to
- Registry conditions: Non-small Cell Lung Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug Ensartinib
Ensartinib 225mg oral daily for 3 years or until recurrence of the disease or intolerable toxicity
Primary outcome measures
- 3-year disease free survival rate (DFSR) [Time frame: 3 years]
Secondary outcome measures (4)
- 5-year overall survival rate [Time frame: 5 years]
- disease free survival (DFS) [Time frame: Up to 5 years]
- overall survival (OS) [Time frame: Up to 5 years]
- Adverse Events [Time frame: Up to 3 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Jun Feng Liu — Shijiazhuang
Identifiers
NCT: NCT05241028 · BD-EN-IV006