Pembrolizumab drug monitoring to help treat non‑small cell lung cancer
PEMBRO-K : Evaluation of Pembrolizumab Therapeutic Pharmacological Monitoring Benefit in Non-small Cell Bronchopulmonary Cancer (NSCLC)
This observational project will test whether measuring pembrolizumab levels in adults with non‑small cell lung cancer helps guide treatment decisions or predict side effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Angers Government |
| Drugs / interventions | pembrolizumab |
| Locations | 2 sites (Angers and 1 other locations) |
| Trial ID | NCT06195527 on ClinicalTrials.gov |
What this trial studies
This observational study will follow adults with NSCLC who are receiving pembrolizumab (as monotherapy or in combination) at two French hospitals. Blood samples will be taken via the patient's existing peripheral catheter, PICC, or implantable port to measure pembrolizumab concentrations and potentially related biomarkers. Investigators will correlate drug levels with clinical outcomes such as tumor response and treatment-related toxicity without altering standard care. No experimental treatments are given and treatment decisions remain with the treating physician.
Who should consider this trial
Good fit: Adults (18+) with non‑small cell lung cancer who are receiving pembrolizumab and have an existing peripheral catheter, PICC, or implanted port are ideal candidates.
Not a fit: People not receiving pembrolizumab, patients with small cell lung cancer, or those who cannot provide blood samples via an existing catheter are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, drug-level monitoring could help personalize pembrolizumab dosing to improve treatment effectiveness and reduce side effects.
How similar studies have performed: Therapeutic drug monitoring for immune checkpoint inhibitors is an emerging area with small, mixed studies so far and is not yet standard practice.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or more * patient with NSCLC * pembrolizumab treatment (monotherapy or not) with a placed line (peripheral catheter, PICC or implantable port) Exclusion Criteria: * objection to participate in the study * patient under judicial protection
Where this trial is running
Angers and 1 other locations
- Angers University Hospital — Angers, France (Recruiting)
- CH Le Mans — Le Mans, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Guillaume DREVIN, Doctor
- Email: Guillaume.Drevin@chu-angers.fr
- Phone: 0241354551
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.