Clinical trial · Observational
A Real World Study of Ensartinib in Advanced ALK-positive NSCLC
A Real World Study of Ensartinib in Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)
NCT05498064CI-TRIAL-00060272recruitingClinicalTrials.gov clinicaltrialsProvenance
- 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 primary objective of this study is to evaluate the efficacy and safety of Ensartinib in advanced ALK-positive non-small cell lung cancer, and the mechanisms of population pharmacokinetics and resistance to Ensartinib.
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 |
|---|---|---|---|
| Anaplastic Lymphoma Kinase I1171N | — | UNRESOLVED | — |
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Ensartinib | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ensartinib | Drug | Ensartinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression free survival (PFS)
- timeFrame
- 36 months
- description
- Defined as time from first dose of Ensartinib to disease progression or death due to any causes
Secondary outcomes (4)
- measure
- The objective response rate (ORR)
- timeFrame
- 36 months
- description
- ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR).
- measure
- Overall survival (OS)
- timeFrame
- 48 months
- description
- OS, defined as time from first dose of Ensartinib to death due to any cause
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed stage III b or IV NSCLC, according to the International Association for the Study of Lung Cancer staging manual in Thoracic Oncology, 8th edition. 2. Documented ALK-positive disease according to FISH , Ventana IHC ,RT-PCR or NGS; 3. Patients must have demonstrated progression during or after ALK-TKI treatment; 4. Eastern cooperative oncology group performance status (ECOG PS) of 0-2, overall survival\>3 months; 5. Patients need radiotherapy or can receive radiotherapy, such as bone metastatic lesions, intrapulmonary lesions, adrenal lesions, etc. 6. Initially general blood tests including complete blood count, biochemistry, electrolytes, and urine biochemistry were performed as a routine screening in order to identify any abnormalities. 7. Male and female patients must agree to abstain or to use two highly effective forms of contraception during the treatment period and for 90 days after the last dose of study medication. Exclusion Criteria: \-
References
Publications (0)
Data not yet available
No reference posted for this study.