Circulating Tumor DNA Guided Treatment Monitoring in Advanced Lung Cancer

Non-small Cell Lung Cancer Metastatic Clinical Trial

— PRELUCA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05889247
• Other study ID #: SJ-1011
• Status: Recruiting
• Phase: N/A
• Start date: July 28, 2023
• Est. completion date: June 2032

Study information

• Verified date: July 2023
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: June 2032
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Non-small Cell Lung Cancer Metastatic

Intervention

Other:
• 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)

Locations

Country	Name	City	State
Denmark	Department of Oncology	Aalborg
Denmark	Department of Clinical Oncology and Palliative Care	Naestved	Zealand
Denmark	Department of Oncology	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Overall Survival	through study completion, an average of 3 years
Secondary	Physicians Global Assessment to measure quality of life	Physicians Global Assessment to measure quality of life	through study completion, an average of 3 years
Secondary	Common Terminology Criteria for Adverse Events	Common Terminology Criteria for Adverse Events	through study completion, an average of 3 years