Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty recruiting
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Treatment-naive NSCLC patients
- description
- 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.
- interventionNames
- Drug: Pembrolizumab
Primary outcomes (1)
- measure
- Objective response
- timeFrame
- 3 months
- description
- Radiological response (Partial response/stable disease/Complete response)
Secondary outcomes (4)
- measure
- Adverse events
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available