Pembrolizumab for Metastatic NSCLC Patients Expressing PD-L1 Who Have Their Own PDX
NCT03134456 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2024-12-03
Summary
This is a single center, open-label, single arm study in patients with metastatic non-small cell lung cancer (NSCLC) expressing PD-L1 after failure of platinum-based combination chemotherapy.
Patients will be treated with Pembrolizumab according to the dosage and administration in Product Information of Keytruda in Korea (2mg/kg) until it is changed to 200mg flat dose.
The patient should have their-own patient-derived xenograft (PDX) before enrollment of the study. The PDX will be used to set up their humanized CD34 PDX (Hu-CD34 PDX).
Conditions
- Metastatic Non-Small Cell Lung Carcinoma
Interventions
- DRUG
-
Pembrolizumab Injection
Pembrolizumab according to the dosage and administration in Product Information of Keytruda in Korea (2mg/kg) until it is changed to 200mg flat dose.
Sponsors & Collaborators
-
Samsung Medical Center
lead OTHER
Principal Investigators
-
sehoon lee, MD · Samsung Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-14
- Primary Completion
- 2019-07-08
- Completion
- 2023-07-13
Countries
- South Korea
Study Locations
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