Clinical trial NCT03215693: X-396 Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-07-12
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Objective response rate (ORR) based on independent radiology review
timeFrame: 24 months
Secondary outcomes:
measure: ORR based on investigator assessment
timeFrame: 24 months
measure: Progression-free survival (PFS) as assessed by independent radiology review and investigator
timeFrame: 36 months
measure: Overall survival (OS)
timeFrame: 36 months
Other outcomes:
measure: Overall intracranial response rate (OIRR) by independent radiology review and investigator assessment
timeFrame: 24 months
measure: Patient reported time to deterioration (TTD) as measured by EORTC C30/LC13 QoL questionnaire
timeFrame: 24 months
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Beijing Chest Hospital，Capital Medical University
city: Beijing
country: China
facility: Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Peking Union College Hospital
Study officials:
affiliation: Sun Yat-sen University
name: Li Zhang, MD
role: STUDY_CHAIR
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.