Clinical trial NCT05241028: Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Ensartinib
adjuvant therapy
ALK
Tyrosine kinase inhibitor
Lead sponsor: Hebei Medical University Fourth Hospital
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


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.

Primary outcomes:
measure: 3-year disease free survival rate (DFSR)
timeFrame: 3 years
Secondary outcomes:
measure: 5-year overall survival rate
timeFrame: 5 years
measure: disease free survival (DFS)
timeFrame: Up to 5 years
measure: overall survival (OS)
timeFrame: Up to 5 years
measure: Adverse Events
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Jun Feng Liu
state: Hebei
Study officials:
References: