150
Participants
Start Date
April 9, 2019
Primary Completion Date
January 31, 2025
Study Completion Date
January 31, 2025
TAGRISSO® 80mg (Osimertinib)
Oral administration of TAGRISSO® 80mg (Osimertinib) as a single daily dose until disease progression or unacceptable toxicity.
Tumor biopsies
"Tumor biopsies performed at baseline and clinical progression will be processed (fixed) on site, and sent to Nantes University Hospital for analysis.~The following analysis will be performed:~1. Analyses performed on a regular basis, in order to allow subsequent inclusion in other clinical trials :~ * C797S testing (digital PCR)~ * MET amplification (dPCR/FISH)~ * Histological examination of the tissue sample (to identify small cell transformation)~ * Expression of proteins by immunohistochemistry: PD-L1 (Ventana SP263 antibody); CD73 ; CD4; CD8.~2. At the end of inclusions, deep sequencing analysis to identify acquired mutations and copy number variations (amplifications)."
ctDNA analysis
"ctDNA analysis by Collection of plasma (two 10-ml Streck tubes) at each time point indicated in the trial.~These samples will be sent at room temperature by courier to the central laboratory (Nantes University Hospital). There they will be centrifuged, and plasma will be frozen (-80°C).~Analyses :~* Detection of the EGFR activating mutation in plasma at baseline By dPCR (characterization of patients enrolled)~* Detection of the EGFR activating mutation at d7 and m1 by dPCR (early detection of response to osimertinib)~* Analysis of the plasma samples collected at clinical progression in order to identify acquired mechanisms of resistance by NGS (and comparison with analysis of the biopsies).~* Kinetics studies of the alterations"
AP-HM Hôpital Nord Marseille, Marseille
Crlcc Francois Baclesse, Caen
Chru Pontchaillou, Rennes
Chu Tours, Tours
Chu Grenoble, La Tronche
CHU de Nantes, Nantes
CHU d'ANGERS, Angers
CH de Cholet, Cholet
Hôpital Calmette CHRU de Lille, Lille
Chru Strasbourg, Strasbourg
CH DU MOENCHSBERG - Hôpital Emile Muller, Mulhouse
CH Le Mans, Le Mans
Institut Curie, Paris
AP-HP Hôpital Tenon, Paris
Chits Ch Sainte Musse, Toulon
CHD Vendée, La Roche-sur-Yon
C H I Créteil, Créteil
Collaborators (1)
AstraZeneca
INDUSTRY
Nantes University Hospital
OTHER