Non-Small Cell Lung Cancer
Conditions
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.
Interventions
DRUGX-396 capsule
225mg once daily
Sponsors
Betta Pharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall intracranial response rate (OIRR) by independent radiology review and investigator assessment | 24 months | OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who have measureable disease in the brain at baseline. |
| Patient reported time to deterioration (TTD) as measured by EORTC C30/LC13 QoL questionnaire | 24 months | 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 |
Countries
China
Outcome results
None listed