Predictive Gene Profiles and Dynamic Measurement of Treatment Response in Metastatic Non-small Cell Lung Cancer

February 3, 2023 updated by: Zealand University Hospital

The study aims include:

  • Exploring potential predictive molecular profiles to immunotherapy/chemotherapy
  • Investigating the role of circulating tumor DNA as a dynamic biomarker during immunotherapy/chemotherapy
  • Identifying possible resistance mechanisms to immunotherapy/chemotherapy

Materials and methods:

Approximately 150 patients diagnosed with metastatic NSCLC assigned for immunotherapy or chemotherapy will be candidates for inclusion during a 1-2 years period.

A comprehensive molecular profiling will be made from the diagnostic biopsy. Before every treatment-cycle a blood sample will be taken to quantify ctDNA. At time of progressive disease during/after first line treatment, patients will be asked to participate in a new biopsy and a comprehensive molecular profiling will be performed.

The tissue and blood samples collected will be stored in a biobank. Clinical data will be collected to perform a comprehensive database.

Analysis:

Potentially predictive molecular profiles for immunotherapy/chemotherapy will be found by comparison of treatment outcome for patients with specific molecular characteristics.

Through quantification of ctDNA during treatment and upon progression, the role of ctDNA as a dynamic biomarker will be further strengthened.

Differences in molecular profiles pre- and post-treatment may reveal resistance mechanisms to treatment. Molecular profiling on progression can be valuable in second-line treatment guidance.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

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

Study Locations

  • Denmark
    • Zealand
      • Naestved, Zealand, Denmark
        • Department of Oncology

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

Non-Probability Sample

Study Population

Metastatic non-small cell lung cancer.

Description

Inclusion Criteria:

  • Age > 18 years
  • Able to understand and read Danish
  • WHO Performance status 0-2
  • Acceptable organ function (liver/kidney/heart) for treatment
  • The disease has to be:

evaluable or measurable according to RECIST/iRECIST accessible for biopsy metastatic or not suitable for curative intended treatment

Exclusion Criteria:

  • Other active cancers
  • Contraindications for systemic therapy
  • ALK-positive, ROS-1 or EGFR mutations

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive gene profiles
Time Frame: until progression or death, an average of 3 years
Concordance between specific gene profiles and treatment outcomes
until progression or death, an average of 3 years
Resistance mechanisms toward chemotherapy and immunotherapy
Time Frame: until progression or death, an average of 3 years
Differences in molecular profiles pre- and post-treatment
until progression or death, an average of 3 years
ctDNA as a dynamic biomarker
Time Frame: until progression or death, an average of 3 years
Quantification of ctDNA during treatment linked to treatment outcome
until progression or death, an average of 3 years

Collaborators and Investigators

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

Sponsor

Zealand University Hospital

Investigators

  • Principal Investigator: Frank S Malene, MD, Region Zeland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 29, 2018

Primary Completion (ACTUAL)

November 6, 2022

Study Completion (ACTUAL)

November 6, 2022

Study Registration Dates

First Submitted

March 26, 2018

First Submitted That Met QC Criteria

April 30, 2018

First Posted (ACTUAL)

May 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

February 3, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REG-006-2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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