Overview
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;
Description
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:
Eligibility
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.