Observational studyBMC cancer2026
Evaluation of the exposure-response relationship of pembrolizumab in non-small cell lung cancer: observational study protocol in real-world clinical practice.
Observational study in BMC cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPembrolizumab is a monoclonal antibody used in various oncological indications. This antibody is directed against programmed cell death receptor type 1. The expression of this receptor is used as a marker of treatment efficacy. In the search for response biomarkers, several authors have studied the relationship between plasma concentrations of pembrolizumab and response to treatment. However, these results are contradictory, and greater knowledge of the exposure-response association of these drugs is needed to predict response based on blood concentrations. The two primary objectives are to study the relationship between the pembrolizumab minimum steady-state concentration and (1) progression-free survival and (2) the clinical benefit rate, in patients with metastatic non-small cell lung cancer.
methodWe designed a prospective, longitudinal, observational study at a single center. Patients with metastatic non-small cell lung cancer undergoing treatment with pembrolizumab are being included. Peripheral blood samples will be collected from enrolled patients at treatment initiation and, once steady state is reached, at each treatment reassessment, coinciding with routine blood tests. Once plasma is obtained from the samples, it will be frozen until analysis. The plasma drug concentration will be measured using specific commercial ELISA test kits. Demographic, clinical, and treatment data will be collected in a data collection form. DISCUSSION: With this project, we want to advance personalized cancer medicine by providing real-world data. Because resources are limited, establishing guidelines that reduce costs while maintaining the same efficacy would allow us to be more efficient. The limitations of this project stem from its single-center nature, which limits the number of patients and blood samples.
trial registrationThis project is registered in the Spanish Clinical Studies Registry of the Spanish Agency of Medicines and Medical Devices under the title: “NIPE-TDM Study: Evaluation of the concentration–response relationship of immunotherapy in oncology patients: real-world clinical experience,” code: NIPE-TDM, identifier: 0131-2024-OBS, AEMPS No.: 24-00145.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.