Status:
UNKNOWN
Study of KN046 With Chemotherapy in First Line Advanced NSCLC
Lead Sponsor:
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a phase II study of KN046 plus platinum-based doublet chemotherapy in previously untreated advanced non-squamous and squamous NSCLC subjects. The study will assess primarily the safety and ef...
Eligibility Criteria
Inclusion
- Key
- Has a histologically or cytologically confirmed diagnosis of stage IV NSCLC;
- Has not received prior systemic treatment for metastatic NSCLC;
- Has measurable disease based on RECIST 1.1.
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
- Has adequate organ function.
- Has provided tumor tissue from locations not radiated prior to biopsy.
- Key
Exclusion
- Previous immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways)
- Previously untreated or symptomatic central nervous system (CNS) metastases
- Has received a live-virus vaccination within 28 days of planned treatment start.
- Previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody and chemotherapy.
- Has or had active autoimmune disease.
Key Trial Info
Start Date :
September 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04054531
Start Date
September 4 2019
End Date
June 1 2021
Last Update
September 10 2019
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 51000