Clinical trial · Interventional
X-396 (Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases
Efficacy and Safety of X-396 (Ensartinib) in ALK-Positive NSCLC Patients With Brain Metastases: A Phase Ⅱ, Open-Label, Single Arm, Multicenter Study
NCT04415320CI-TRIAL-00045388unknownPhase 2ClinicalTrials.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)
To assess efficacy and safety of oral X-396 (Ensartinib) capsule in Chinese ALK-positive NSCLC patients with brain metastases, eligible patients will be enrolled with objective responses being primary outcome measures.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | — | UNRESOLVED | — |
| Lung Cancer, Nonsmall Cell | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| X-396(Ensartinib) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- X-396(Ensartinib) Capsule
- interventionNames
- Drug: X-396(Ensartinib)
Primary outcomes (1)
- measure
- Intracranial objective response rate (iORR) based on investigator assessment according to RNAO-BM.
- timeFrame
- 12 weeks
- description
- iORR per RANO-BM calculated as the proportion of patients with a best intracranial overall response defined as complete response (CR) or partial response (PR), based on investigator assessment.
Secondary outcomes (14)
- measure
- Disease control rate based on intracranial response (iDCR) according to RANO-BM.
- timeFrame
- 12 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female or male, 18 years of age or older 2. Histologically or cytologically confirmed locally advance or recurrent/metastatic NSCLC that was positive for ALK mutations. 3. Contrast-enhanced MRI or CT confirmed parenchymal brain metastases with at least one measurable lesion (according to RANO and RECIST 1.1), which was not previously treated with radiotherapy. 4. At most once treated with chemotherapy, which must have been completed at least 4 weeks before the initiation of study treatment. Any adverse events related to previous chemotherapy treatment have disappeared. 5. A Karnofsky Performance Status score of at least 60. 6. An expected survival time of at least 12 weeks. 7. Adequate organ functions. 8. Drug related toxicities has been relieved to grade 1 (based on NCI CTCAE v4.03), except for hair loss. 9. Being willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures. 10. Signed and dated informed consent. Exclusion Criteria: 1. Currently under treatment of other systemic anti-cancer therapies. 2. Evidence of active malignancy within last 5 years. 3. Patients who participated in other clinical trials within last 4 weeks before the initiation of study treatment. 4. Patients who received surgery or immunotherapy within last 4 weeks before the initiation of study treatment. 5. Patients who need to receive drugs which are potent CYP3A4 inhibitors or inducers within last 2 weeks before the initiation of study treatment and during the study. 6. Patients who previously received organ transplantation or stem cell transplantation. 7. Patients with clinically significant cardiovascular diseases. 8. Patients with active gastrointestinal diseases or other conditions that will interfere significantly with the absorption, distribution, metabolism or excretion of study medication. 9. Patients with interstitial lung disease history or signs of active interstitial lung disease. 10. Patients with known allergy or delayed hypersensitivity reaction to study drug or its excipients. 11. Pregnant and lactating women. 12. Patients with other illness or medical conditions potentially interfering with the study treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.