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

University of Oslo (UIO)

Status: Terminated

Conditions: NSCLC

Treatments: Drug: Pembrolizumab

Study type: Observational

Funder types: Other

Identifiers

NCT04557007

2017/9660

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

80 participants in 1 patient group

Treatment-naive NSCLC patients

Description:

Treatment-naive NSCLC patients receiving immunotherapy (pembrolizumab) alone or in combination With chemotherapy divided in groups based on treatment administered. Clinical information will be gathered at start of treatment and at evaluations every 3rd month.

Treatment:

Drug: Pembrolizumab