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

Recruiting

• Conditions: NSCLC
• Interventions: Drug: Pembrolizumab

• Registration Number: NCT04557007
• Lead Sponsor: Oslo University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study Start: 2020-09-01
• Study First Submitted: 2020-09-02
• Study First Submitted QC: 2020-09-15
• Last Update Submitted: 2020-09-15
• Study First Posted: 2020-09-21
• Last Update Posted: 2020-09-21
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

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Exclusion Criteria

• Any anti-cancer therapy < 6 months prior to inclusion

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment-naive NSCLC patients	Pembrolizumab	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.

Primary Outcome Measures

Name	Time	Method
Objective response	3 months	Radiological response (Partial response/stable disease/Complete response)

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years observation	Overall survival related to drug trough-level
Adverse events	2 years	Adverse events \>= 3
PD-1 Expression on CD-8 T-cells	First 3 months	Proliferation of PD-1 Expression CD-8 T-cells
Progression-Free survival	1 year	Radiological evaluation

Trial Locations

Locations (1)

St Olavs University Hospital; 🇳🇴 Trondheim, Norway