Spots Global Cancer Trial Database for Pembrolizumab for Metastatic NSCLC Patients Expressing PD-L1 Who Have Their Own PDX

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Trial Identification

Brief Title: Pembrolizumab for Metastatic NSCLC Patients Expressing PD-L1 Who Have Their Own PDX

Official Title: Pembrolizumab for Metastatic Non-small Cell Lung Cancer (NSCLC) Patients Expressing PD-L1 Who Have Their Own Patient-derived Xenograft (PDX): Comparative Study of Clinical Response and In-vivo Antitumor Response Using Their Humanized CD34 PDX (Hu-CD34 PDX)

Study ID: NCT03134456

Conditions

Metastatic Non-Small Cell Lung Carcinoma

Interventions

Pembrolizumab Injection

Study Description

Brief 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).

Detailed Description: Part A: Clinical trial (single arm study) in patients with metastatic non-small cell lung cancer (NSCLC) expressing PD-L1 after failure of platinum-based combination chemotherapy. Part B: PDX experiment using Hu-CD34 PDX model in specific population selected from Part A (Clinical trial part) - responder and non-responder. In-vivo experiment using Hu-CD34 PDX will be done for about seven subjects, and thirty-two (32) Hu-CD34 PDX mice will be established from single patient to see in-vivo response. This research using PDX (Part B) will be conducted sequentially on clinical trial part in selected-population based on clinical response of Pembrolizumab.