ALK Positive, NSCLC Stage IIIB, NSCLC Stage IV
Conditions
Brief summary
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 1. Efficacy and safety; 2. The relationship between molecular mechanism and curative effect; 3. Ensatinib resistance mechanism;
Detailed description
Enrolled patients: 1. stage IIIB or stage IV NSCLC 2. Each center confirmed ALK+ by tissue samples (Abbott FISH, VENTANA ALK D5F3, NGS method confirmation); 3. 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:
Interventions
DRUGEnsatinib
Prospective, exploratory, single-arm, multi-center, real-world research
Sponsors
Betta Pharmaceuticals Co., Ltd.
Peking University Cancer Hospital & Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. stage IIIB or stage IV NSCLC by histology or cytology; 2. All centers confirmed ALK positive by tissue samples (Abbott FISH, VENTANA ALK D5F3, NGS method confirmation); 3. Without any ALK-TKI treatment; 4. Voluntarily and capable of following the trial and follow-up procedures; 5. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival | 2021.09.27-2024.12.30 |
Secondary
| Measure | Time frame |
|---|---|
| overall survival | 2021.09.27-2024.12.30 |
| Time-to-TreatmentFailure | 2021.09.27-2024.12.30 |
Countries
China
Contacts
Primary ContactJun Zhao, PhD
Backup ContactXue Yang Yang
Outcome results
None listed