Non-small Cell Lung Cancer MetastaticPRELUCANCT05889247
Circulating Tumor DNA Guided Treatment Monitoring in Advanced Lung Cancer
A study testing Circulating tumor DNA treatment monitoring in people with Non-small Cell Lung Cancer Metastatic, run by Zealand University Hospital at 5 sites in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-small Cell Lung Cancer Metastatic
- What is being tested?
- Circulating tumor DNA treatment monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 5 sitesDenmark
- Study dates
- 28 Jul 2023to Jun 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Targetable alterations in EGFR, ALK or ROS-1
- Other active cancers
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Denmark5 sites, 5 recruiting
- Not yet recruiting
Department of Oncology
Aalborg
Weronika Maria Szejniuk, MD, PhD
- Recruiting
Department of Clinical Oncology
Hillerød, Region H
Stine Wahlstrøm, Medical Oncologist, +45 48296103, stine.wahlstroem.03@regionh.dk
Malene S Frank, Medical Oncologist, malf@regionsjaelland.dk
- Recruiting
Department of Clinical Oncology and Palliative Care
Næstved, Region Sjælland
Malene Støchkel Frank, MD, PhD, 56513279 ext. 45, malf@regionsjaelland.dk
Michael Elmkvist Andersen, MD, mielan@regionsjaelland.dk
- Recruiting
Department of Clinical Oncology and Palliative Care
Roskilde, Region Sjælland
Malene Støchkel Frank, MD, PhD, 56513279 ext. 45, malf@regionsjaelland.dk
Michael Elmkvist Andersen, MD, mielan@regionsjaelland.dk
- Not yet recruiting
Department of Oncology
Vejle
Christa Haugaard Nyhus, MD
Torben Frøstrup Hansen, Professor
About this study
Official title: 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.
Read the 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.
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Being tested
- Circulating tumor DNA treatment monitoring
- Keywords
- liquid biopsy, treatment monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating tumor DNA treatment monitoringOther
Also called Quality of Life assessments
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)
| Study group | Role | What they receive |
|---|---|---|
| ctDNA monitoring | Experimental | Treatment monitoring by longitudinal circulating tumor DNA measurements and Quality of Life assessments Receives: Other: Circulating tumor DNA treatment monitoring |
| CT scan monitoring | No intervention | Treatment monitoring by longitudinal CT scans (standard) and Quality of Life Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall Survival
Measured: through study completion, an average of 3 years
Secondary outcomes (4)
Physicians Global Assessment to measure quality of life
Physicians Global Assessment to measure quality of life
Measured: through study completion, an average of 3 years
Common Terminology Criteria for Adverse Events
Common Terminology Criteria for Adverse Events
Measured: through study completion, an average of 3 years
Number of Treatments
Number of treatments given and not given
Measured: From randomization to first detection of progressive disease, an average of 3 years
Health Cost/Utility
A health cost and utility analysis of patients in both arms
Measured: From randomization to first detection of progressive disease, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start28 Jul 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malene Støchel Frank, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889247
- Sponsor's protocol ID
- SJ-1011
- Acronym
- PRELUCA
- Status last verified
- Jan 2026
- First submitted
- 8 May 2023
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andersen ME, Nyhus CH, Szejniuk WM, Wahlstrom S, Timm S, Pallisgaard N, Madsen MG, Mikkelsen MD, Ahlborn LB, Gehl J, Frank MS. ctDNA guided immunotherapy in patients with advanced non-small cell lung cancer: a nationwide Danish, randomised, intervention study (PRELUCA-PRediction in LUng CAncer Treatment) - study protocol. BMJ Open. 2026 Feb 2;16(2):e100311. doi: 10.1136/bmjopen-2025-100311.
PubMed 41628935
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA Guided Treatment Monitoring in Advanced Lung Cancer - a Randomized Interventional Study
- ClinicalTrials.gov ID
- NCT05889247
- Acronym / sponsor ID
- PRELUCA / SJ-1011
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Keywords
- liquid biopsy, treatment monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2032 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ctDNA monitoring | Experimental | Other: Circulating tumor DNA treatment monitoringTreatment monitoring by longitudinal circulating tumor DNA measurements and Quality of Life assessments |
| CT scan monitoring | No intervention | –Treatment monitoring by longitudinal CT scans (standard) and Quality of Life Assessments |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- Targetable alterations in EGFR, ALK or ROS-1
- Other active cancers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circulating tumor DNA treatment monitoringAlso: Quality of Life assessmentsA 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 | ctDNA monitoring |
Primary outcome
Overall Survival
Time frame: through study completion, an average of 3 years
Overall Survival
4 secondary outcomes
Physicians Global Assessment to measure quality of life
Time frame: through study completion, an average of 3 years
Common Terminology Criteria for Adverse Events
Time frame: 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
Health Cost/Utility
Time frame: From randomization to first detection of progressive disease, an average of 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Derived from this study: PubMed 41628935Andersen ME, Nyhus CH, Szejniuk WM, Wahlstrom S, Timm S, Pallisgaard N, Madsen MG, Mikkelsen MD, Ahlborn LB, Gehl J, Frank MS. ctDNA guided immunotherapy in patients with advanced non-small cell lung cancer: a nationwide Danish, randomised, intervention study (PRELUCA-PRediction in LUng CAncer Treatment) - study protocol. BMJ Open. 2026 Feb 2;16(2):e100311. doi: 10.1136/bmjopen-2025-100311.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Department of Clinical Oncology and Palliative Care
Næstved, Denmark
Department of Clinical Oncology and Palliative Care
Roskilde, Denmark
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circulating tumor DNA treatment monitoring in people with Non-small Cell Lung Cancer Metastatic, run by Zealand University Hospital at 5 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05889247, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.