Phase I/II study of AF802 in patients with Non-Small Cell Lung Cancer harboring ALK fusion gene
Phase 1
- Conditions
- non-small-cell lung cancer
- Registration Number
- JPRN-jRCT2080221227
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Those patients who have been confirmed histologically or cytologically to have non-small cell lung cancer.
-Those patients whose tumor samples related to non-small cell lung cancer are confirmed to be positive for ALK fusion gene expression.
-Those patients who have received 2 or more chemotherapy regimens.(Phase1)
-Those patients who have received 1 or more chemotherapy regimens.(Phase2)
Exclusion Criteria
-Those patients who have been treated with an ALK inhibitor in the past.
-Those patients who are currently under other investigational treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety, PK parameters (Phase 1)<br>Response rate (Phase 2)
- Secondary Outcome Measures
Name Time Method Tumor regression effect (Phase 1)<br>Safety, Efficacy, PK parameters (Phase 2)