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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab | Other | Pembrolizumab 200 mg i.v., every 3 weeks, maximum of 2 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-L1 positive vs PD-L1 negative NSCLC patients | Other | Genomic analyses of PD-L1 positive vs PD-L1 negative NSCLC patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | Complete and partial remission, stable disease; measured by computertomography; RECIST 1.1 criteria | 6 months after start of treatment |
| PFS | Distribution of PFS of patients | Time from start of treatment to radiologically confirmed progressive disease or death due to any cause, whichever came first, assessed up to 24 months. |
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Subject inclusion criteria:
Subject exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sabine Zöchbauer-Müller, MD | Contact | +43 1 40400 | 44290 | sabine.zoechbauer-mueller@meduniwien.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Sabine Zöchbauer-Müller, MD | Medical University of Vienna, Vienna, Austria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |