Circulating Tumor DNA Guided Treatment Monitoring in Advanced Lung Cancer (PRELUCA)

January 6, 2026 updated by: Malene Støchel Frank, Zealand University Hospital

Circulating Tumor DNA Guided Treatment Monitoring in Advanced Lung Cancer - a Randomized Interventional Study

The study is a prospective randomized interventional study including patients with advanced non-small cell lung cancer, receiving immunotherapy, with the aim of optimizing treatment monitoring. The study aims to investigate the clinical utility of liquid biopsy monitoring in order to reduce the numbers of inefficient treatments and needless toxicity - and to explore the cost-effectiveness and cost-utility of introducing liquid biopsy monitoring in daily clinical practice.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Lung cancer is the leading cause of cancer-related death worldwide with Non-Small Cell Lung Cancer (NSCLC) being the most common subtype. Performance status deterioration due to progressive symptoms and toxicity by treatments are major challenges in managing advanced NSCLC patients. Moreover, standard treatment monitoring by radiologic scans is often imprecise. This technology has limited sensitivity as only a visible increase or decrease in tumor mass can be evaluated, making interpretation challenging and conclusions of whether patients benefit from treatment indefinite. Interpretation of radiologic scans has been further challenged after implementation of immunotherapy, causing immunotherapy-induced recruitment of immune cells resembling increment in tumor size, called "pseudo-progression." More sensitive methods are highly needed to reduce ineffective treatments and needless toxicity. Liquid biopsy has the potential to overcome these challenges by measuring molecular changes with high precision in a dynamic manner. Recent studies have demonstrated its promising potential as a biomarker predictive of treatment efficacy and overall survival. In a recent real-life study, investigators found that ctDNA measurements could reduce 33% of likely inefficient treatments and clarify 79% of non-conclusive CT-scans, highlighting the clinical potential. A randomized interventional multicenter study will be performed, investigating the true clinical potenial of liquid biopsy compared to standard monitoring by radiological scans. A total of 350 patients with advanced NSCLC will be included in the study from three Departments of Clinical Oncology. In the interventional arm, liquid biopsy monitoring will be the basis for treatment discontinuation before the standard two years of immunotherapy in patients reaching a complete molecular response in plasma. Thus clarifying the question if treatment duration can be reduced for the benefit of patients and health cost.

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Not Applicable

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
      • Aalborg, Denmark
        • Not yet recruiting
        • Department of Oncology
        • Contact:
          • Weronika Maria Szejniuk, MD, PhD
      • Vejle, Denmark
        • Not yet recruiting
        • Department of Oncology
        • Contact:
          • Christa Haugaard Nyhus, MD
        • Contact:
          • Torben Frøstrup Hansen, Professor
    • Region H
    • Region Sjælland
      • Næstved, Region Sjælland, Denmark
      • Roskilde, Region Sjælland, Denmark

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Newly diagnosed, histologically verified, Non-Small Cell Lung Cancer (NSCLC)
  • Advanced or locally advanced disease without curative intended treatment options
  • Age > 18 years
  • Eastern Cooperative Oncology Group (ECOG) score of Performance Status (PS) 0-1
  • Measurable disease according to the iRECIST criteria version 1.1.
  • Eligible to first line immunotherapy (monotherapy)
  • Signed informed consent

Exclusion Criteria:

  • Targetable alterations in EGFR, ALK or ROS-1
  • Other active cancers

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ctDNA monitoring
Treatment monitoring by longitudinal circulating tumor DNA measurements and Quality of Life assessments
Other: Circulating tumor DNA treatment monitoring
A comparison of treatment monitoring by circulating tumor DNA and CT scans (standard) in patients with newly diagnosed advanced Non-Small Cell Lung Cancer (NSCLC)
Other Names:
  • Quality of Life assessments
No Intervention: CT scan monitoring
Treatment monitoring by longitudinal CT scans (standard) and Quality of Life Assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: through study completion, an average of 3 years
Overall Survival
through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physicians Global Assessment to measure quality of life
Time Frame: through study completion, an average of 3 years
Physicians Global Assessment to measure quality of life
through study completion, an average of 3 years
Common Terminology Criteria for Adverse Events
Time Frame: through study completion, an average of 3 years
Common Terminology Criteria for Adverse Events
through study completion, an average of 3 years
Number of Treatments
Time Frame: From randomization to first detection of progressive disease, an average of 3 years
Number of treatments given and not given
From randomization to first detection of progressive disease, an average of 3 years
Health Cost/Utility
Time Frame: From randomization to first detection of progressive disease, an average of 3 years
A health cost and utility analysis of patients in both arms
From randomization to first detection of progressive disease, 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

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)

July 28, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2032

Study Registration Dates

First Submitted

May 8, 2023

First Submitted That Met QC Criteria

May 25, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJ-1011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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