NSCLC Stage IV Clinical Trial
— EFLRWROfficial title:
Prospective Exploratory Real World Study of Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer
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;
Status | Recruiting |
Enrollment | 180 |
Est. completion date | October 30, 2024 |
Est. primary completion date | October 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Cancer Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Cancer Hospital | Betta Pharmaceuticals Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | progression-free survival | 2021.09.27-2024.12.30 | ||
Secondary | overall survival | 2021.09.27-2024.12.30 | ||
Secondary | Time-to-TreatmentFailure | 2021.09.27-2024.12.30 |
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