Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer

NCT05241028 | Recruiting Phase 2

• 1 other identifier: BD-EN-IV006
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Ensartinib; adjuvant therapy; ALK; Tyrosine kinase inhibitor

Outcome Measures

Primary Outcomes (1)

• 3-year disease free survival rate (DFSR)

  Defined as the percentage of patients alive and disease free at 3 years

  3 years

Secondary Outcomes (4)

• 5-year overall survival rate

  5 years

• disease free survival (DFS)

  Up to 5 years

• overall survival (OS)

  Up to 5 years

• Adverse Events

  Up to 3 years

Study Arms (1)

Ensartinib

EXPERIMENTAL

Ensartinib 225mg oral daily for 3 years or until recurrence of the disease or intolerable toxicity

Drug: Ensartinib

Interventions

Ensartinib DRUG

Ensartinib 225mg oral daily for 3 years or until recurrence of the disease or intolerable toxicity

Also known as: X-396 capsule

Ensartinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

Jun Feng Liu

Shijiazhuang, Hebei, 050011, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

ensartinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Junfeng Liu, PhD

CONTACT

13931152296; liujf@hbmu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of thoracic surgery

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 15, 2022
• Study Start: May 1, 2022
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2029
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)