Clinical trial · Observational
Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer
Prospective Exploratory Real World Study of Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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;
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ALK Positive | — | UNRESOLVED | — |
| NSCLC Stage IIIB | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| NSCLC Stage IV | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ensatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ensatinib for treated patients with ALK-positive advanced non-small cell lung cancer
- description
- Ensatinib 225mg QD Until the disease progresses or intolerance
- interventionNames
- Drug: Ensatinib
Primary outcomes (1)
- measure
- progression-free survival
- timeFrame
- 2021.09.27-2024.12.30
Secondary outcomes (2)
- measure
- overall survival
- timeFrame
- 2021.09.27-2024.12.30
- measure
- Time-to-TreatmentFailure
- timeFrame
- 2021.09.27-2024.12.30
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available