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Trial Title:
Circulating Tumor DNA Guided Treatment Monitoring in Advanced Lung Cancer
NCT ID:
NCT05889247
Condition:
Non-small Cell Lung Cancer Metastatic
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
liquid biopsy
treatment monitoring
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
Circulating tumor DNA treatment monitoring
Description:
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)
Arm group label:
ctDNA monitoring
Other name:
Quality of Life assessments
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.
Criteria for 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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Clinical Oncology and Palliative Care
Address:
City:
Naestved
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Malene Støchkel Frank, MD, PhD
Phone:
56513279
Phone ext:
45
Email:
malf@regionsjaelland.dk
Contact backup:
Last name:
Michael Elmkvist Andersen, MD
Email:
milan@regionsjaelland.dk
Facility:
Name:
Department of Oncology
Address:
City:
Aalborg
Country:
Denmark
Status:
Not yet recruiting
Contact:
Last name:
Weronika Maria Szejniuk, MD, PhD
Facility:
Name:
Department of Oncology
Address:
City:
Vejle
Country:
Denmark
Status:
Not yet recruiting
Contact:
Last name:
Christa Haugaard Nyhus, MD
Contact backup:
Last name:
Torben Frøstrup Hansen, Professor
Start date:
July 28, 2023
Completion date:
June 2032
Lead sponsor:
Agency:
Zealand University Hospital
Agency class:
Other
Source:
Zealand University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05889247
