The Efficacy and Safety of Ensartinib As Adjuvant Therapy in Stage I ALK-positive NSCLC Patients with High Risk Factors

NCT06772610 | Not Yet Recruiting Phase 2

• 1 other identifier: 2024LY1286
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to evaluate the efficacy and safety of a 2-year adjuvant treatment with Ensartinib in stage I ALK-positive non-small cell lung cancer (NSCLC) patients with high-risk factors. The study population includes patients with ALK-positive NSCLC who have undergone R0 resection and have not received any postoperative treatment, with a TNM stage of I and high-risk factors for recurrence.

Conditions

NSCLC; ALK; Stage I; Adjuvant Treatment

Keywords

NSCLC; ALK positive; adjuvant treatment; high-risk factors

Outcome Measures

Primary Outcomes (1)

• 2 year disease-free survival rate

  2-year DFS rate refers to the percentage of patients who remain free of any signs or symptoms of the disease (in this case, cancer) for two years after receiving treatment.

  up to 2 year

Secondary Outcomes (2)

• 5 year overall survival rate.

  up to 5 year

• Disease-free survival

  up to 5 year

Study Arms (1)

Treatment group

EXPERIMENTAL

Ensartinib 200 mg, once daily, orally, for a continuous period of 2 years.

Drug: Ensartinib group

Interventions

Ensartinib group DRUG

Ensartinib 200 mg, once daily, orally, for a continuous period of 2 years.

Treatment group

Eligibility Criteria

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

You may qualify if:

• Aged 18-75 years;
• ECOG performance status 0-1;
• Postoperative histopathology confirms R0 resection with TNM stage I pulmonary adenocarcinoma;
• Confirmed ALK fusion-positive by FISH, IHC, or NGS;
• No prior systemic treatment after surgery;
• At least one high-risk recurrence factor: poorly differentiated tumor, vascular invasion, wedge resection, visceral pleura involvement, uncertain lymph node status, intrapulmonary dissemination;
• Able to start Ensartinib adjuvant therapy within 4-8 weeks after surgery;
• Hematological, biochemical, and organ function requirements met: Hemoglobin ≥100 g/L; Absolute neutrophil count ≥1.5×10\^9/L; Platelet count ≥100×10\^9/L; Total bilirubin ≤2 times the upper limit of normal; ALT and AST ≤2.5 times the upper limit of normal; Creatinine ≤1.5 times the upper limit of normal; Creatinine clearance ≥60 mL/min;
• Women of childbearing potential must have a negative urine pregnancy test - within 7 days prior to starting treatment;
• Informed consent obtained from the patient or their legal representative;
• Men and women of childbearing potential must agree to use reliable - contraception from enrollment in the study until 8 weeks after discontinuation of the study drug.

You may not qualify if:

• Previous systemic treatment for NSCLC;
• Previous local radiotherapy for NSCLC;
• Unable to take oral medications;
• Known allergy to Ensartinib or any component of this product;
• History of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring steroid treatment, or any clinically evident active interstitial lung disease; baseline CT scan showing idiopathic pulmonary fibrosis;
• Any unstable systemic diseases, including: active infections, uncontrolled hypertension, unstable angina, angina onset within the last 3 months, congestive heart failure (≥ NYHA class II), myocardial infarction (within 6 months prior to enrollment), severe arrhythmias requiring medication, liver, kidney, or metabolic diseases;
• Pregnant or breastfeeding women;
• History of definite neurological or psychiatric disorders, including epilepsy or dementia;
• Any other conditions that the investigator deems unsuitable for enrollment.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Central Study Contacts

Li Wang, MD

CONTACT

1817021997; leewang8023@126.com

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 Clinical Research Center, Shanghai Pulmonary Hospital

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 13, 2025
• Study Start: March 15, 2025
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2032
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share