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

Not Applicable

Completed

• Conditions: Metastatic Non-small Cell Lung Cancer
• Interventions: Other: ctDNA analysis

• Registration Number: NCT03926260
• Lead Sponsor: Centre Hospitalier Departemental Vendee

Brief 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

Study Timeline

• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2019-04-23
• Study First Posted: 2019-04-24
• Study Start: 2019-06-27
• Primary Completion: 2021-07-30
• Study Completion: 2022-05-23
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-28
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Metastatic or locally advanced non-small cell lung cancer (stage III or IV)
• At least one measurable target according to RECIST criteria
• Identification of at least one molecular alteration in the tissue sample analyzed in the framework of patient management
• Performance Status 0 to 2
• Affiliated to a social security system
• Patient who can be followed under the protocol
• Patient agreed to participate in the study and gave his/her express consent

Exclusion Criteria

• Minor
• Small cell or mixed bronchial cancer
• Radiotherapy (except radiotherapy for antalgic purposes) during the last 7 days
• Patient who has already started a first line of treatment
• Patient already included in an interventional research protocol that may have an impact on the results of the ELUCID study
• History of cancer (with the exception of non-melanoma skin, cervical cancer in situ, adequately treated) with sign of illness during the last 5 years
• Patient which, does present a substantial risk of recurrence.
• Major under guardianship, curators or deprived of liberty
• Pregnant or lactating woman, or of childbearing age without effective contraception
• Not affiliated to a social security system
• Inability to understand the protocol and / or to give express consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ctDNA analysis	ctDNA analysis	additional blood sample of 20 ml

Primary Outcome Measures

Name	Time	Method
Biological response at week 3	week 3 after patient's recruitment date (baseline)	Changes of the amount of ctDNA between baseline and week 3 will make it possible to determine the biological response: increase, stability or decrease in ctDNA.

Secondary Outcome Measures

Name	Time	Method
Biological response and progression-free survival (radiological assessment) according to the therapeutic management: targeted therapies, immunotherapy, chemotherapy	week 3 after baseline	Radiological assessment, based on RECIST criteria v1.1, will be: complete response or partial response. Biological response will be: increase, stability or decrease in ctDNA.
Progression-free survival (radiological assessment) and biological response at week 3.	week 3 after baseline	Radiological assessment, based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria v1.1, will be: complete response, partial response, progression or stabilization. Biological response will be: increase, stability or decrease in ctDNA.
biological progression and radiological progression	progression	Biological progression will be: increase in ctDNA - Radiological progression will be defined according to RECIST criteria v1.1 will be: progression
biological response and radiological response	progression	Biological response will be: increase, stability or decrease in ctDNA and Radiological response will be defined according to RECIST criteria v1.1 will be: complete or partial response

Trial Locations

Locations (2)

Marie MARCQ; 🇫🇷 La Roche-sur-Yon, France

Jaafar BENNOUNA; 🇫🇷 Nantes, France