X-396 Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib

Phase 2

Active, not recruiting

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: X-396 capsule

• Registration Number: NCT03215693
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2017-07-11
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-12
• Study Start: 2017-09-28
• Primary Completion: 2020-03-09
• Status Verified: 2023-07
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-16
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 152

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
X-396 capsule	X-396 capsule	225mg once daily

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR) based on independent radiology review	24 months	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 Outcome Measures

Name	Time	Method
ORR based on investigator assessment	24 months	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).
Progression-free survival (PFS) as assessed by independent radiology review and investigator	36 months	PFS, defined as time from first dose of X-396 to progression or death due to any cause.
Overall survival (OS)	36 months	OS, defined as time from first dose of X-396 to death due to any cause.

Trial Locations

Locations (4)

Beijing Cancer Hospital; 🇨🇳 Beijing, China

Peking Union College Hospital; 🇨🇳 Beijing, China

Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China

Beijing Chest Hospital，Capital Medical University; 🇨🇳 Beijing, China