Actively Recruiting
Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer
Led by Hebei Medical University Fourth Hospital · Updated on 2023-10-10
80
Participants Needed
1
Research Sites
352 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Completely resected pathological stage IB-IIIA NSCLC with ALK-fusion positive confirmed by FISH, IHC or NGS
- Male or female aged 18 to 75 years
- ECOG performance status 0-2
- Fully recovered from surgery or standard postoperative chemotherapy before starting adjuvant Ensartinib (all toxicities greater than CTCAE Grade 1 resolved except hair loss and Grade 2 neuropathy related to platinum treatment)
- Clinical examinations before treatment show no signs of disease recurrence
- Sufficient tumor tissue samples available for molecular marker analysis
- Hemoglobin concentration at least 100 g/L (blood transfusion allowed to maintain this)
- Absolute neutrophil count at least 1.5 x 10^9/L
- Platelet count at least 100 x 10^9/L
- Liver function tests within specified limits: total bilirubin ≤ 2x upper limit of normal; ALT and AST ≤ 2.5x upper limit of normal
- Renal function tests within specified limits: creatinine ≤ 1.5x upper limit of normal, creatinine clearance ≥ 60 ml/min
- Signed informed consent
- Able to follow study procedures and take oral medication
- Female patients of childbearing potential must have a negative urine pregnancy test within 7 days before treatment
- Patients of reproductive potential must agree to use reliable birth control before enrollment, during the study, and for at least 8 weeks after last dose
You will not qualify if you...
- Prior targeted therapy (including tyrosine kinase inhibitors or monoclonal antibodies) or experimental therapy for NSCLC
- Previous local radiotherapy for NSCLC
- Known allergy to Ensartinib or any ingredients in the product
- History of interstitial lung disease, drug-induced interstitial disease, or radiation pneumonia requiring hormone therapy
- Active interstitial lung disease or idiopathic pulmonary fibrosis seen on baseline CT scan
- Unstable systemic diseases such as active infection, uncontrolled high blood pressure, unstable angina within last 3 months, congestive heart failure (NYHA II or higher), myocardial infarction within 6 months, or severe arrhythmia requiring treatment
- Liver, kidney, or metabolic diseases
- Pregnant or breastfeeding women
- History of neurological or psychiatric disorders including epilepsy or dementia
- Any other conditions judged by investigators to make the patient ineligible for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Jun Feng Liu
Shijiazhuang, Hebei, China, 050011
Actively Recruiting
Research Team
J
Junfeng Liu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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