Ignite Creation Date:
2024-05-06 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03571360
Status:
UNKNOWN
Last Update Posted:
2020-06-11
First Post:
2018-06-12
Brief Title:
CTA ExpressionMethylation and Response to Pembrolizumab of NSCLC Patients
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
ExpressionDNA Methylation of Cancer Testis Antigens May Predict Response to Pembrolizumab in Non-small Cell Lung Cancer Patients
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pembrolizumab is a potent and highly selective humanized monoclonal antibody mAb of the IgG4kappa isotype designed to directly block the interaction between PD-1 and its ligands PD-L1 and PD-L2 KeytrudaTM pembrolizumab has been approved by the FDA and the EMA for the therapy of with chemotherapy pretreated NSCLC patients with PD-L1 expression TPS 1 on tumor cells In addition pembrolizumab was approved for the first line treatment of metastatic NSCLC patients with high PD-L1 expression TPS 50 on tumor cells Pembrolizumab will be given in a flat dose of 200 mg iv every 3 weeks until disease progression toxicity or patient withdrawal for a maximum of 2 years Patients with untreated advanced stage lung adenocarcinoma without an EGFR mutation or ALK translocation will be included
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None