NCT03571360

CTA Expression/Methylation and Response to Pembrolizumab of NSCLC Patients

Expression/DNA Methylation of Cancer Testis Antigens May Predict Response to Pembrolizumab in Non-small Cell Lung Cancer Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa 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 i.v. 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.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
OTHER	PD-L1 positive vs PD-L1 negative NSCLC patients	Genomic analyses of PD-L1 positive vs PD-L1 negative NSCLC patients

Timeline

• Start date: 2020-02-10
• Primary completion: 2021-01-14
• Completion: 2021-07-14
• First posted: 2018-06-27
• Last updated: 2020-06-11

Locations

1 site across 1 country: Austria