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

September 15, 2020 updated by: Ragnhild Nome, Oslo University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Norway
      • Trondheim, Norway
        • Recruiting
        • St Olavs University Hospital
        • Contact:
          • Arne Kildahl-Andersen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

NSCLC patients With Advanced disease elligible for routine treatment With immunotherapy alone or in combination With chemotherapy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Pembrolizumab
Drug trough-level will be measured in patients on Pembrolizumab with or without additional chemotherapy in routine care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response
Time Frame: 3 months
Radiological response (Partial response/stable disease/Complete response)
3 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pembrolizumab clearance
Time Frame: 3 months
mg/L
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

St. Olavs Hospital

Investigators

  • Principal Investigator: Ragnhild Nome, MD, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Anticipated)

October 1, 2025

Study Completion (Anticipated)

October 1, 2025

Study Registration Dates

First Submitted

September 2, 2020

First Submitted That Met QC Criteria

September 15, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Actual)

September 21, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/9660

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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