NCT05889247

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
74mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Jul 2023Jun 2032

First Submitted

Initial submission to the registry

May 8, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 28, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2032

Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

3.8 years

First QC Date

May 8, 2023

Last Update Submit

January 6, 2026

Conditions

Non-small Cell Lung Cancer Metastatic

Keywords

liquid biopsytreatment monitoring

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    Overall Survival

    through study completion, an average of 3 years

Secondary Outcomes (4)

  • Physicians Global Assessment to measure quality of life

    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

    From randomization to first detection of progressive disease, an average of 3 years

  • Health Cost/Utility

    From randomization to first detection of progressive disease, an average of 3 years

Study Arms (2)

ctDNA monitoring

EXPERIMENTAL

Treatment monitoring by longitudinal circulating tumor DNA measurements and Quality of Life assessments

Other: Circulating tumor DNA treatment monitoring

CT scan monitoring

NO INTERVENTION

Treatment monitoring by longitudinal CT scans (standard) and Quality of Life Assessments

Interventions

Circulating tumor DNA treatment monitoringOTHER

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)

Also known as: Quality of Life assessments
ctDNA monitoring

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Department of Clinical Oncology

Hillerød, Region H, Denmark

RECRUITING

Department of Clinical Oncology and Palliative Care

Næstved, Region Sjælland, Denmark

RECRUITING

Department of Clinical Oncology and Palliative Care

Roskilde, Region Sjælland, Denmark

RECRUITING

Department of Oncology

Aalborg, Denmark

NOT YET RECRUITING

Department of Oncology

Vejle, Denmark

NOT YET RECRUITING

Related Publications (1)

  • 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.

    PMID: 41628935DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Oncologist, PhD

Study Record Dates

First Submitted

May 8, 2023

First Posted

June 5, 2023

Study Start

July 28, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2032

Last Updated

January 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(5)