MedTrace Logo

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

NCT04557007 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2026-01-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Pembrolizumab

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

Sponsors & Collaborators

  • St. Olavs Hospital

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Ragnhild Nome, MD · Oslo University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-10-01
Completion
2022-10-01
FDA Drug
Yes

Countries

  • Norway

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04557007 on ClinicalTrials.gov