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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04557007

Acronym

Oncomabs

Enrollment

Registered

2020-09-21

Start date

2020-09-01

Completion date

2022-10-01

Last updated

2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC

Brief summary

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.

Interventions

DRUGPembrolizumab

Drug trough-level will be measured in patients on Pembrolizumab with or without additional chemotherapy in routine care.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
Objective response	3 months	Radiological response (Partial response/stable disease/Complete response)

Secondary

Measure	Time frame	Description
Adverse events	2 years	Adverse events \>= 3
PD-1 Expression on CD-8 T-cells	First 3 months	Proliferation of PD-1 Expression CD-8 T-cells
Overall survival	5 years observation	Overall survival related to drug trough-level
Progression-Free survival	1 year	Radiological evaluation

Countries

Norway

Contacts

PRINCIPAL_INVESTIGATORRagnhild Nome, MD

Oslo University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026