Drug Concentration Monitoring of Pembrolizumab in Non-Small Cell Lung Cancer Patients

Drug Concentration Monitoring of Pembrolizumab in Treatment-naive Non-Small Cell Lung Cancer Patients

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.

Inclusion Criteria:

• Subjects must be > 18 years and must voluntary sign an informed consent
• Treatment-naïve patients with advanced NSCLC receiving immunotherapy alone (pembrolizumab) or combined with chemotherapy

Exclusion Criteria:

• Any anti-cancer therapy < 6 months prior to study start
• Radio- or chemotherapy against lung cancer <2 years before study start
• Previous treatment with immunotherapy
• Patients with mutations with specific treatment (i.e. EGFR, ALK, Ros1)