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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 28, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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