Status:
RECRUITING
Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer
Lead Sponsor:
Hebei Medical University Fourth Hospital
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2029
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05241028
Start Date
May 1 2022
End Date
February 1 2029
Last Update
October 10 2023
Active Locations (1)
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1
Jun Feng Liu
Shijiazhuang, Hebei, China, 050011