Official Title
Liquid Biopsies in Patients With Advanced Non-small Cell Lung Cancer
Brief Title
LIquid BIopsies in Patients Presenting Non-small Cell Lung Cancer
Protocol ID
NCT02511288
Lead Sponsor
Centre Leon Berard
Brief 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
Detailed 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.
Enrollment Count
900 participants
Eligibility Criteria
COHORT 1
Inclusion Criteria:
- Patients with histologically confirmed advanced non-small-cell lung carcinoma (stage
IIIB/IV) regardless of the mutation status
- Inclusion at the time of diagnostic
- Realization of tumor biopsy at the institution (Centre Léon Bérard) or outside the
institution with an available histopathological report
- Age ≥ 18 years
- Covered by a health insurance
- Signed consent
Exclusion Criteria:
- Patients treated before their liquid biopsy
COHORT 2 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 Léon Bérard) 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 Léon Bérard) 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
Filters
Carcinoma, Non-Small-Cell Lung
RECRUITING
ADULT
OLDER_ADULT