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

Metastatic Non-small Cell Lung Cancer Clinical Trial

— ELUCID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03926260
• Other study ID #: CHD 160-18
• Status: Completed
• Phase: N/A
• Start date: June 27, 2019
• Est. completion date: May 23, 2022

Study information

• Verified date: June 2022
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 23, 2022
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Metastatic Non-small Cell Lung Cancer

Intervention

Other:
• ctDNA analysis
blood sample at Baseline, 3weeks, 9 weeks after treatment, at progression if applicable

Locations

Country	Name	City	State
France	Marie MARCQ	La Roche-sur-Yon
France	Jaafar BENNOUNA	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biological response at week 3	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.	week 3 after patient's recruitment date (baseline)
Secondary	Progression-free survival (radiological assessment) and biological response at week 3.	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.	week 3 after baseline
Secondary	biological progression and radiological progression	Biological progression will be: increase in ctDNA - Radiological progression will be defined according to RECIST criteria v1.1 will be: progression	progression
Secondary	biological response and radiological response	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	progression
Secondary	Biological response and progression-free survival (radiological assessment) according to the therapeutic management: targeted therapies, immunotherapy, chemotherapy	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.	week 3 after baseline