Clinical trial Recruiting at 3 sites Interventional

Monitoring treatment in advanced lung cancer using liquid biopsy

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

Run by Zealand University Hospital · NCT05889247 · Data updated 2026-11-12

This study is testing if a blood test can help doctors better track treatment progress in people with advanced lung cancer who are receiving immunotherapy, compared to regular scans.

Quick facts

Study typeInterventional
SexAll
Enrollment350 (estimated)
SponsorZealand University Hospital
Academic / other
Drugs / interventionsimmunotherapy
Locations5 sites (Hillerød, Region H and 4 other locations)
StatusRecruiting
StartedJuly 28, 2023
Main results expectedJune 2027
Study endsJune 2032
Registry record updatedJanuary 9, 2026
Trial IDNCT05889247 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 with newly diagnosed, histologically verified advanced non-small cell lung cancer who are eligible for first-line immunotherapy.

Probably not a fit

Patients with targetable alterations in EGFR, ALK, or ROS-1 or those with other active cancers may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the use of liquid biopsy to monitor treatment in patients with advanced non-small cell lung cancer (NSCLC) receiving immunotherapy. It aims to optimize treatment monitoring by reducing ineffective treatments and minimizing unnecessary toxicity. The study will compare the clinical utility of circulating tumor DNA (ctDNA) measurements against traditional radiologic scans, which can be imprecise and challenging to interpret, especially after immunotherapy. By employing a randomized interventional multicenter approach, the study seeks to establish the cost-effectiveness and utility of liquid biopsy in everyday clinical practice.

Why it matters

Potential benefit: If successful, this approach could lead to more effective treatment monitoring and improved outcomes for patients with advanced lung cancer.

How similar studies have gone: Previous studies have shown promising results with liquid biopsy approaches, indicating potential success for this novel methodology.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Amivantamab with platinum chemotherapy for metastatic EGFR‑mutant non‑small cell lung cancer

    This study will try giving amivantamab together with platinum chemotherapy to adults with metastatic NSCLC who have specific EGFR mutations to see how long their cancer stays controlled and how safe the treatment is.

    Recruiting at 11 sites Groupe Francais De Pneumo-Cancerologie · Aix-en-Provence and 15 other locations · NCT07563205

  • OM-RCA-01 (anti-FGFR1 antibody) for metastatic tumors that express FGFR1

    This trial will try OM-RCA-01, an IV antibody given every two weeks, in adults with metastatic cancers whose tumors test positive for FGFR1 and who have progressed after standard treatments.

    Recruiting at 4 sites Phase 1/2 Kidney Cancer Research Bureau · Kazan' and 4 other locations · NCT07292168

  • Proteomic-guided, risk-adapted therapy for advanced non-small cell lung cancer

    This trial tests whether using a proteomic test plus a toxicity risk tool to pick immune checkpoint inhibitor–based treatment can improve 12-month progression-free survival for people with previously untreated advanced non-small cell lung cancer.

    Recruiting at 4 sites Phase 2 University of California, Davis · Chico, California and 3 other locations · NCT07250477

  • First-line nivolumab plus ipilimumab with short-course chemotherapy for metastatic non-small cell lung cancer

    This project will collect real-world data to see if nivolumab plus ipilimumab combined with a short course of platinum chemotherapy works well as first-line treatment for adults with metastatic non-small cell lung cancer who do not have EGFR or ALK alterations.

    Recruiting Fondazione IRCCS Policlinico San Matteo di Pavia · Pavia, Lombardy · NCT07190677

  • PF-08046054 (SGN-PDL1V) versus docetaxel for PD-L1–positive advanced non-small cell lung cancer

    This test compares PF-08046054 (SGN-PDL1V) with docetaxel for adults whose PD-L1–positive advanced NSCLC progressed after PD-1/PD-L1 inhibitors, platinum chemotherapy, and targeted treatments when appropriate.

    Recruiting at 454 sites Phase 3 Pfizer · Alabaster, Alabama and 468 other locations · NCT07144280

  • Cemiplimab guided by ctDNA levels (PALACE)

    This study will see if starting adults with advanced (stage IIIB/C or IV) non-small cell lung cancer and PD-L1 ≥50% on cemiplimab, then using ctDNA and early scans to decide whether to add chemotherapy, can improve overall survival.

    Recruiting at 19 sites Phase 2 Fundación GECP · Alicante, Alicante and 19 other locations · NCT06917573

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.