Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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The experimental design is exploratory, single-arm, multi-center, real-world research. Ensatinib 225mg qd A prospective and exploratory real-world study of Ensatinib for ALK-positive advanced non-small cell lung cancer patients Test purposes Exploring the real world, Ensatinib is effective for the newly treated ALK+ advanced NSCLC Efficacy and safety; The relationship between molecular mechanism and curative effect; Ensatinib resistance mechanism;

Detailed Description
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Enrolled patients: stage IIIB or stage IV NSCLC Each center confirmed ALK+ by tissue samples (Abbott FISH, VENTANA ALK D5F3, NGS method confirmation); Without any ALK-TKI treatment; Study endpoint Primary endpoint: According to the RECIST1.1 standard, the progression-free survival (PFS) assessed by the investigator; Secondary endpoint: According to the RECIST1.1 standard, the objective response rate (ORR) evaluated by the investigator; the time to treatment failure (TTF); according to the RECIST1.1 standard, the ORR and PFS of patients with different ALK fusion subtypes evaluated by the investigator; total Lifetime (OS); safety; Exploratory endpoint: The correlation between the biomarkers in blood or/and tissue samples and the efficacy of Ensatinib; the resistance mechanism of Ensatinib; The sample size is determined: The plan is to analyze 60-80 patients with EML4-ALK fusion v1 and v3 subtypes. Based on the proportion of patients with both subtypes in ALK-positive patients, the proportion is about 40%. Based on the 20% dropout rate, the plan is to include ALK without distinction. 180 patients with fusion subtype; statistical methods:

Official Title
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Prospective Exploratory Real World Study of Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer

Conditions
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ALK Positive, NSCLC Stage IIIB, NSCLC Stage IV

Intervention / Treatment
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* Drug: Ensatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stage IIIB or stage IV NSCLC by histology or cytology; All centers confirmed ALK positive by tissue samples (Abbott FISH, VENTANA ALK D5F3, NGS method confirmation); Without any ALK-TKI treatment; Voluntarily and capable of following the trial and follow-up procedures; Able to understand the nature of the trial, and be able to complete the signing of a written informed consent form. Exclusion Criteria: 1. Pereceived any ALK-TKI treatment ; 2. Received any chemotherapy within 4 weeks, or underwent major surgery or radiotherapy within the last 14 days; 3. The investigator believes that the patient is not suitable for Ensatinib treatment. Had a stem cell or organ transplant. 4. Having serious cardiovascular disease, including but not limited to: 5.Sino - QTcF interval ≥450 ms or other significant ECG abnormalities. According to the study, researchers either ruled that hypertension was poorly controlled (systolic blood pressure >160 mmHg or diastolic blood pressure >100mmHg). 6. Dysphagia, active gastrointestinal disease, or other disease that significantly affects drug absorption, distribution, metabolism, and excretion. 7. Previous history of interstitial lung disease, drug-induced interstitial lung disease, radioactive pneumonia requiring steroid treatment, or any indication of clinically active interstitial lung disease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ensatinib for treated patients with ALK-positive advanced non-small cell lung cancer<br>Ensatinib 225mg QD Until the disease progresses or intolerance | Drug: Ensatinib<br>* Prospective, exploratory, single-arm, multi-center, real-world research<br>* Other names: BD-EN-IV002;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | 2021.09.27-2024.12.30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 2021.09.27-2024.12.30 | 
| Time-to-TreatmentFailure |  | 2021.09.27-2024.12.30 |