LIquid BIopsies in Patients Presenting Non-small Cell Lung Cancer

  • STATUS
    Recruiting
  • End date
    Dec 13, 2026
  • participants needed
    900
  • sponsor
    Centre Leon Berard
Updated on 13 October 2021
carcinoma
growth factor
BRAF
epidermal growth factor receptor
ROS1
RET
HER2
EGFR
erbb2
epidermal growth factor
liquid biopsy
lung carcinoma
proto-oncogene tyrosine-protein kinase ros

Summary

The goal of this project is to characterize the genetic profile of patients with advanced stage IIIB/IV non-small cell lung cancer (NSCLC) using liquid biopsies

Description

Lung cancers are the first cause of death by cancer in the world. The majority of these patients are diagnosed at a late stage, non-eligible to a curative treatment. Due to tumoral genomic identification, it has been possible to classify NSCLC in molecular subtypes according to molecular abnormalities detection called "drivers" which can be targeted using an appropriate treatment. This change modifies the standard treatments from the very first line of treatment particularly for patients having an EGFR mutation or an ALK or ROS1 rearrangement, with a significant benefit of progression free survival. The French NCI (INCa) recommends to identify genomic alterations of a genes panel including EGFR, KRAS, BRAF, HER2, ALK and ROS1 as well as mutations in MET exon 14. However, all the patients who benefit from a targeted therapy develop resistance after a mean duration of 10-12 months after starting the treatment. In case of progression, the tumour genetic analysis through new biopsies, enables to identify these mechanisms and then to determine if the patient can benefit or not from a third generation molecule active on these mechanisms, and to have a better understanding of the disease evolution.

The detection of these alterations is routinely performed using tissular biopsies but in 10 to 20% of the cases, it is not possible.

The detection of these molecular abnormalities in the plasma, called " liquid biopsy " is a valuable non-invasive complementary approach for these patients. It is presently used in routine for detecting the EGFR mutations at diagnosis as well as for searching EGFR T790M mutation for resistant patients.

The liquid biopsies enable to detect circulating tumoral DNA.

Details
Condition Non-Small Cell Lung Cancer
Clinical Study IdentifierNCT02511288
SponsorCentre Leon Berard
Last Modified on13 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with histologically confirmed advanced non-small-cell lung carcinoma (stage IIIB/IV) with one of the following molecular anomalies: Epidermal Growth Factor Receptor (EGFR), B-Raf proto oncogene (BRAF) or Human Epidermal Growth Factor Receptor-2 (HER2) mutations, Anaplatsic Lymphoma Kinase (ALK) or ROS porto-oncogene 1 (ROS1) translocation, Mesenchymal-epithelial transition factor (MET) amplification, RET rearrangement
Inclusion at the time of diagnosis
Realization of tumor biopsy at the institution (Centre Lon Brard) or outside the institution with an available histopathological report
Age 18 years
Covered by a health insurance
Signed consent
COHORT 3 Inclusion criteria
Patients with histologically confirmed advanced non-small-cell lung carcinoma (stage IIIB/IV) whatever the mutational or PD-L1 status
Inclusion at the time of immunotherapy treatment initiation (1st or 2nd line)
Realization of tumor biopsy at the institution (Centre Lon Brard) or outside the institution with an available histopathological report
Age 18 years
Covered by a health insurance
Signed consent

Exclusion Criteria

Initiation of immunotherpy before their liquid biopsy
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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