RecruitingNot ApplicableNCT05889247

Circulating Tumor DNA Guided Treatment Monitoring in Advanced Lung Cancer

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

Sponsor

Zealand University Hospital

Enrollment

350 participants

Start Date

Jul 28, 2023

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer Metastatic

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.

Eligibility

Inclusion Criteria7

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 Criteria2

Targetable alterations in EGFR, ALK or ROS-1
Other active cancers

Interventions

OTHERCirculating 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)