KN046 in Patients With Advanced Non-small Cell Lung Cancer
NCT03838848 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2023-03-02
Summary
This is a phase II, open label, multicenter study in subjects with advanced non-small cell lung cancer.
Conditions
- Stage IV Non-small Cell Lung Cancer
Interventions
- DRUG
-
KN046
3mg/kg, Q2W, intravenous injection (IV)
- DRUG
-
KN046
5mg/kg, Q2W, intravenous injection (IV)
- DRUG
-
KN046
5mg/kg, Q3W, intravenous injection (IV)
- DRUG
-
AUC 5 IV Q3W; total dose calculated according to the Calvert formula, with the highest dose not exceeding 750 mg; 4 cycles.
- DRUG
-
Pemetrexed
500 mg/m2, Q3W, intravenous injection (IV)
- DRUG
-
Ningetinib
Oral, QD
Sponsors & Collaborators
-
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
lead INDUSTRY
Principal Investigators
-
Caicun Zhou, MD · Shanghai Pulmonary Hospital, Shanghai, China
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-05-05
- Primary Completion
- 2022-07-30
- Completion
- 2022-07-30
Countries
- China
Study Locations
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