Monitoring drug levels of pembrolizumab in lung cancer patients
Drug Concentration Monitoring of Pembrolizumab in Treatment-naive Non-Small Cell Lung Cancer Patients
This study looks at how the levels of the lung cancer drug pembrolizumab in the blood affect the health outcomes of patients with Non-Small Cell Lung Cancer who are just starting treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Drugs / interventions | pembrolizumab, chemotherapy, immunotherapy |
| Locations | 1 site (Trondheim) |
| Trial ID | NCT04557007 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between drug trough-levels of pembrolizumab and clinical outcomes in patients with Non-Small Cell Lung Cancer (NSCLC). It will involve collecting blood samples from 250 treatment-naïve patients receiving pembrolizumab, either alone or in combination with chemotherapy, during their first-line treatment. The study will also monitor T-cell responses and anti-drug antibodies to correlate these findings with patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are treatment-naïve adults over 18 years old with advanced NSCLC who are starting immunotherapy with pembrolizumab.
Not a fit: Patients who have received any anti-cancer therapy within the last six months will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help optimize pembrolizumab treatment by identifying the ideal drug levels associated with better clinical outcomes.
How similar studies have performed: While the approach of monitoring drug levels in relation to outcomes is common, this specific study's focus on pembrolizumab in NSCLC is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 inclusion
Where this trial is running
Trondheim
- St Olavs University Hospital — Trondheim, Norway (Recruiting)
Study contacts
- Principal investigator: Ragnhild Nome, MD — Oslo University Hospital
- Study coordinator: Ragnhild Nome, MD
- Email: ragnom@ous-hf.no
- Phone: +4798602658
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.