Trials / Terminated
TerminatedNCT04557007
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 80 (actual)
- Sponsor
- Oslo University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Pembrolizumab | Drug trough-level will be measured in patients on Pembrolizumab with or without additional chemotherapy in routine care. |
Timeline
- Start date
- 2020-09-01
- Primary completion
- 2022-10-01
- Completion
- 2022-10-01
- First posted
- 2020-09-21
- Last updated
- 2026-01-29
Locations
1 site across 1 country: Norway
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04557007. Inclusion in this directory is not an endorsement.