Study of KN046 With Chemotherapy in First Line Advanced NSCLC

An Open-label, Phase II Study of KN046 Evaluating the Efficacy and Safety of KN046 Plus Platinum-based Doublet Chemotherapy as First Line Therapy in Advanced Non-small Cell Lung Cancer Subjects.

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 efficacy of KN046 plus platinum-based doublet chemotherapy.

Key Inclusion Criteria:

• 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 Criteria:

• 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.