CTA Expression/Methylation and Response to Pembrolizumab of NSCLC Patients
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Other: PD-L1 positive vs PD-L1 negative NSCLC patients
- Registration Number
- NCT03571360
- Lead Sponsor
- Medical University of Vienna
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 42
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pembrolizumab PD-L1 positive vs PD-L1 negative NSCLC patients Pembrolizumab 200 mg i.v., every 3 weeks, maximum of 2 years
- Primary Outcome Measures
Name Time Method Response rate 6 months after start of treatment Complete and partial remission, stable disease; measured by computertomography; RECIST 1.1 criteria
PFS Time from start of treatment to radiologically confirmed progressive disease or death due to any cause, whichever came first, assessed up to 24 months. Distribution of PFS of patients
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Medical University of Vienna
🇦🇹Vienna, Austria