This observational study explores associations between drug trough-levels and clinical outcomes in Non Small Cell Lung Cancer (NSCLC) patients treated with immunotherapy (pembrolizumab) either alone or combined with chemotherapy. Through-levels of pembrolizumab will be examined in blood samples collected during the first-line treatment period. In addition T-cell responses in peripheral blood and anti-drug antibodies will be monitored. Results of drug trough-levels and T-cell responses will be linked to clinical outcome. 250 patients with NSCLC will be enrolled in this trial.
Study Type
OBSERVATIONAL
Enrollment
80
Drug trough-level will be measured in patients on Pembrolizumab with or without additional chemotherapy in routine care.
St Olavs University Hospital
Trondheim, Norway
Objective response
Radiological response (Partial response/stable disease/Complete response)
Time frame: 3 months
Adverse events
Adverse events \>= 3
Time frame: 2 years
PD-1 Expression on CD-8 T-cells
Proliferation of PD-1 Expression CD-8 T-cells
Time frame: First 3 months
Overall survival
Overall survival related to drug trough-level
Time frame: 5 years observation
Progression-Free survival
Radiological evaluation
Time frame: 1 year
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