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
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Enrollment
- 152
- Locations
- 4
- Primary Endpoint
- Objective response rate (ORR) based on independent radiology review
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
X-396 capsule
225mg once daily
Intervention: X-396 capsule (Drug)
Outcomes
Primary Outcomes
Objective response rate (ORR) based on independent radiology review
Time Frame: 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 Outcomes
- ORR based on investigator assessment(24 months)
- Progression-free survival (PFS) as assessed by independent radiology review and investigator(36 months)
- Overall survival (OS)(36 months)