TriangleNCT03215693 · CITED IN SOURCE DOCUMENTS
X-396 Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE2
- Status at capture
- UNKNOWN
- Registry last update
- 2023-08-16
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility Criteria
- 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.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- 225mg once daily
- intervention Names
- Drug: X-396 capsule
- label
- X-396 capsule
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- X-396 capsule
- description
- 225mg once daily
- name
- X-396 capsule
- other Names
- Ensartinib
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 152
- type
- ESTIMATED
Registered outcome plans (not posted results)
- other Outcomes
- description
- OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who have measureable disease in the brain at baseline.
- measure
- Overall intracranial response rate (OIRR) by independent radiology review and investigator assessment
- time Frame
- 24 months
- description
- Time to deterioration (TTD) is defined at the time from date of randomization to a worsening of at least 10 points (on a 100 point scale) in each item score of the EORTC C30/LC13
- measure
- Patient reported time to deterioration (TTD) as measured by EORTC C30/LC13 QoL questionnaire
- time Frame
- 24 months
- primary Outcomes
- 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
- Objective response rate (ORR) based on independent radiology review
- time Frame
- 24 months
- secondary Outcomes
- 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
- ORR based on investigator assessment
- time Frame
- 24 months
- description
- PFS, defined as time from first dose of X-396 to progression or death due to any cause.
- measure
- Progression-free survival (PFS) as assessed by independent radiology review and investigator
- time Frame
- 36 months
- description
- OS, defined as time from first dose of X-396 to death due to any cause.
- measure
- Overall survival (OS)
- time Frame
- 36 months
Full study description
- brief Summary
- 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.
- detailed Description
- This is a phase II, multicenter, single-arm study in which the safety and efficacy of X-396(Ensartinib) will be assessed in adult Chinese patients with ALK-positive(rearrangement) non-small cell lung cancer previously treated with crizotinib. Approximately 144 patients with locally advanced or metastatic NSCLC which carry ALK -rearrangement will be enrolled in the study.
Source references
- references
- citation
- Yang 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
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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- occurrences
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- llowing trials: eXALT3 Study (N=143) [see Clinical Studies ( 14.1 ) ], Study 101 (NCT01625234, N=98), Study BTP-28311 (NCT02959619, N=35), and Study BTP-42322 (NCT03215693, N=182). Patients received ENSACOVE 225 mg orally once daily, with or without food, until disease progression or unacceptable toxicity. Among 458 patients who
- end
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Preserved source evidence · Not medical advice