NCT03926260

Early Assessment of Response to Treatment of Metastatic LUng Tumors Based on CIrculating Tumor DNA

Non-controlled Prospective Pilot Study Assessing Prognostic Performance of Circulating Tumour DNA Kinetic Analysis for Monitoring Response to Treatment of Metastatic Non-small Cell Lung Cancers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Centre Hospitalier Departemental Vendee · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In patients with locally advanced or metastatic tumors, first-line therapeutic management is based on the use of targeted therapies (EGFR, BRAF ALK and ROS1 inhibitors), immunotherapies (anti-PD1/ anti-PDL1-antibodies or chemotherapy. Despite patient selection based on histo-pathological and molecular criteria, not all patients respond to treatment. There are currently no markers to definitively guarantee a patient's response. An alternative is to identify early patient response to treatment. The investigator hypothesize that change in circulating tumor DNA concentration (ctDNA) allow to early identify patients' therapeutic response (and non-response) of patients, regardless of the type of treatment used in the first line setting.

Detailed description

The primary objective is to determine whether early evolution (between baseline and week 3) of circulating tumor DNA concentration predicts the radiological response to first-line treatment of advanced or metastatic NSCLC patients, regardless of treatment

Conditions

• Metastatic Non-small Cell Lung Cancer

Interventions

Type	Name	Description
OTHER	ctDNA analysis	blood sample at Baseline, 3weeks, 9 weeks after treatment, at progression if applicable

Timeline

• Start date: 2019-06-27
• Primary completion: 2021-07-30
• Completion: 2022-05-23
• First posted: 2019-04-24
• Last updated: 2025-12-04

Locations

2 sites across 1 country: France