Clinical trial · Interventional
Circulating Tumor DNA Guided Treatment Monitoring in Advanced Lung Cancer
Circulating Tumor DNA Guided Treatment Monitoring in Advanced Lung Cancer - a Randomized Interventional Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Circulating tumor DNA treatment monitoring | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ctDNA monitoring
- description
- Treatment monitoring by longitudinal circulating tumor DNA measurements and Quality of Life assessments
- interventionNames
- Other: Circulating tumor DNA treatment monitoring
- type
- NO_INTERVENTION
- label
- CT scan monitoring
- description
- Treatment monitoring by longitudinal CT scans (standard) and Quality of Life Assessments
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- through study completion, an average of 3 years
- description
- Overall Survival
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAndersen 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 41628935