Drug Concentration Monitoring of Pembrolizumab in Non-Small Cell Lung Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2025-10-01

Brief Summary

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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.

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Detailed Description

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Conditions

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NSCLC

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Pembrolizumab

Intervention Type DRUG

Drug trough-level will be measured in patients on Pembrolizumab with or without additional chemotherapy in routine care.

Interventions

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Pembrolizumab

Drug trough-level will be measured in patients on Pembrolizumab with or without additional chemotherapy in routine care.

Intervention Type DRUG

Eligibility Criteria

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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