Circulating Tumor DNA Guided Treatment Monitoring in Advanced Lung Cancer

NCT ID: NCT05889247

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-28
• Study Completion Date: 2032-06-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ctDNA monitoring

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

Group Type: EXPERIMENTAL

Circulating tumor DNA treatment monitoring

Intervention Type: OTHER

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)

CT scan monitoring

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)

Intervention Type: OTHER

Other Intervention Names

Quality of Life assessments

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zealand University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Malene Støchel Frank

Medical Oncologist, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Clinical Oncology

Hillerød, Region H, Denmark

Site Status: RECRUITING

Department of Clinical Oncology and Palliative Care

Næstved, Region Sjælland, Denmark

Site Status: RECRUITING

Department of Clinical Oncology and Palliative Care

Roskilde, Region Sjælland, Denmark

Site Status: RECRUITING

Department of Oncology

Aalborg, , Denmark

Site Status: NOT_YET_RECRUITING

Department of Oncology

Vejle, , Denmark

Site Status: NOT_YET_RECRUITING

Countries

Denmark

Facility Contacts

Stine Wahlstrøm, Medical Oncologist

Role: primary

stine.wahlstroem.03@regionh.dk

+45 48296103

Malene S Frank, Medical Oncologist

Role: backup

malf@regionsjaelland.dk

Malene Støchkel Frank, MD, PhD

Role: primary

malf@regionsjaelland.dk

56513279 ext. 45

Michael Elmkvist Andersen, MD

Role: backup

mielan@regionsjaelland.dk

Malene Støchkel Frank, MD, PhD

Role: primary

malf@regionsjaelland.dk

56513279 ext. 45

Michael Elmkvist Andersen, MD

Role: backup

mielan@regionsjaelland.dk

Weronika Maria Szejniuk, MD, PhD

Role: primary

Christa Haugaard Nyhus, MD

Role: primary

Torben Frøstrup Hansen, Professor

Role: backup

Other Identifiers

SJ-1011

Identifier Type: -

Identifier Source: org_study_id