Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT03134456
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.
Study:
NCT03134456
Study Brief:
Protocol Section:
NCT03134456