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

NSCLC Clinical Trial

— Oncomabs  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04557007
• Other study ID #: 2017/9660
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: October 1, 2025

Study information

• Verified date: September 2020
• Source: Oslo University Hospital
• Contact: Ragnhild Nome, MD
• Phone: +4798602658
• Email: ragnom[@]ous-hf.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 inclusion

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

Intervention

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

Locations

Country	Name	City	State
Norway	St Olavs University Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pembrolizumab clearance	mg/L	3 months
Primary	Objective response	Radiological response (Partial response/stable disease/Complete response)	3 months
Secondary	Adverse events	Adverse events >= 3	2 years
Secondary	PD-1 Expression on CD-8 T-cells	Proliferation of PD-1 Expression CD-8 T-cells	First 3 months
Secondary	Overall survival	Overall survival related to drug trough-level	5 years observation
Secondary	Progression-Free survival	Radiological evaluation	1 year