ALK-positive Non-small Cell Lung Cancer
Conditions
Brief summary
The main purpose of the study is to evaluate safety and efficacy of Alkotinib 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
The drug being tested in this study is called alkotinib. Alkotinib has been demonstrated to benefit people with ALK+ NSCLC. The study is a non-control study. The study will enroll approximately 104 participants. All participants will take alkotinib 300mg throughout the study. This multi-center trial will be conducted in China. The overall time to participate in this study is 3 years. Participants will make multiple visits to the site, and 28 days after last dose of study drug for a follow-up assessment.
Interventions
DRUGAlkotinib Capsules
Alkotinib 400mg QD
Sponsors
Suzhou Zelgen Biopharmaceuticals 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
* 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 * At least one measurable lesion by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1). * Willingness and ability to comply with the trial and follow-up procedures.
Exclusion criteria
* chemotherapy, radiation therapy, immunotherapy within 4 weeks. * Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications. * Uncontrolled mass of pleural effusion, pericardial effusion, and peritoneal effusion
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 |
|---|---|---|
| Progression-free survival (PFS) as assessed by independent radiology review and investigator | 36 months | PFS, defined as time from first dose of Alkotinib to progression or death due to any cause. |
| Overall survival (OS) | 36 months | OS, defined as time from first dose of Alkotinib to death due to any cause |
Countries
China
Outcome results
None listed