Drug Concentration Monitoring of Pembrolizumab in Treatment-naive Non-Small Cell Lung Cancer Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Objective response
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Treatment-naive NSCLC patients
Treatment-naive NSCLC patients receiving immunotherapy (pembrolizumab) alone or in combination With chemotherapy divided in groups based on treatment administered. Clinical information will be gathered at start of treatment and at evaluations every 3rd month.
Intervention: Pembrolizumab (Drug)
Outcomes
Primary Outcomes
Objective response
Time Frame: 3 months
Radiological response (Partial response/stable disease/Complete response)
Secondary Outcomes
- Overall survival(5 years observation)
- Adverse events(2 years)
- PD-1 Expression on CD-8 T-cells(First 3 months)
- Progression-Free survival(1 year)
Investigators
Ragnhild Nome
Principal Investigator
Oslo University Hospital