Study of KN046 With Chemotherapy in First Line Advanced NSCLC

• Status: Unknown status
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

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 efficacy of KN046 plus platinum-based doublet chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel; Pemetrexed

Criteria

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.