Clinical trial · Interventional
X-396 Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib
A Phase II, Multicenter, Single-arm Study to Evaluate Safety and Efficacy of X-396 Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib
NCT03215693CI-TRIAL-00068846unknownPhase 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)
The main purpose of the study is to evaluate safety and efficacy of X-396(Ensartinib) capsule in patients with ALK-positive non-small cell lung cancer previously treated with crizotinib.While exploring the relationship between biomarkers and drug efficacy and safety.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| X-396 capsule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- X-396 capsule
- description
- 225mg once daily
- interventionNames
- Drug: X-396 capsule
Primary outcomes (1)
- measure
- Objective response rate (ORR) based on independent radiology review
- timeFrame
- 24 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).
Secondary outcomes (3)
- measure
- ORR based on investigator assessment
- timeFrame
- 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer. * Evidence of positive ALK. * Patients must have demonstrated progression during or after crizotinib treatment. * Age 18 years or older at the time of informed consent. * Eastern cooperative oncology group performance status (ECOG PS) of 0-2 * Measurable disease by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1). * Asymptomatic CNS metastases do not require the use of steroids or anticonvulsants. * Willingness and ability to comply with the trial and follow-up procedures. * Ability to understand the nature of this trial and give written informed consent. Exclusion Criteria: * Prior use of ALK TKIs with the exception of crizotinib. * Patients currently receiving cancer system therapy. * Use of an investigational drug within 4 weeks prior to the first dose of study drug. * Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications. * Patients with a known allergy or delayed hypersensitivity reaction to drugs.
References
Publications (1)
- DERIVEDYang Y, Zhou J, Zhou J, Feng J, Zhuang W, Chen J, Zhao J, Zhong W, Zhao Y, Zhang Y, Song Y, Hu Y, Yu Z, Gong Y, Chen Y, Ye F, Zhang S, Cao L, Fan Y, Wu G, Guo Y, Zhou C, Ma K, Fang J, Feng W, Liu Y, Zheng Z, Li G, Wu N, Song W, Liu X, Zhao S, Ding L, Mao L, Selvaggi G, Yuan X, Fu Y, Wang T, Xiao S, Zhang L. Efficacy, safety, and biomarker analysis of ensartinib in crizotinib-resistant, ALK-positive non-small-cell lung cancer: a multicentre, phase 2 trial. Lancet Respir Med. 2020 Jan;8(1):45-53. doi: 10.1016/S2213-2600(19)30252-8. Epub 2019 Oct 15. PMID 31628085