Using Ensartinib for treating early-stage ALK-positive lung cancer after surgery

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

This study is testing if the drug Ensartinib can help people with early-stage ALK-positive lung cancer stay cancer-free after surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hebei Medical University Fourth Hospital (Academic / other)
• Drugs / interventions: ensatinib, chemotherapy, radiation, Ensartinib
• Locations: 1 site (Shijiazhuang, Hebei)
• Trial ID: NCT05241028 on ClinicalTrials.gov

What this trial studies

This phase 2 clinical trial evaluates the safety and effectiveness of Ensartinib as an adjuvant therapy in patients with stage IB-IIIA non-small cell lung cancer (NSCLC) that is positive for ALK-fusion. Participants will receive Ensartinib for three years or until disease recurrence or intolerable side effects occur, following complete surgical resection of their tumors. The study aims to determine if this targeted therapy can improve outcomes for patients who have undergone surgery and may also have received standard chemotherapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with completely resected stage IB-IIIA ALK-positive NSCLC.

Not a fit: Patients with unresectable disease or those who have not recovered from prior treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve disease-free survival rates for patients with ALK-positive NSCLC after surgery.

How similar studies have performed: Previous studies have shown promising results with targeted therapies in similar patient populations, indicating potential for success in this approach.

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.

Where this trial is running

Shijiazhuang, Hebei

• Jun Feng Liu — Shijiazhuang, Hebei, China (Recruiting)

Study contacts

• Study coordinator: Junfeng Liu, PhD

Conditions Non-small Cell Lung Cancer; Ensartinib; adjuvant therapy; ALK; Tyrosine kinase inhibitor