MEchanisms of Resistance in EGFR Mutated Nonpretreated Advanced Lung Cancer Receiving OSimErtib

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

April 9, 2019

Primary Completion Date

January 31, 2025

Study Completion Date

January 31, 2025

Conditions
Non-small Cell Lung Cancer
Interventions
DRUG

TAGRISSO® 80mg (Osimertinib)

Oral administration of TAGRISSO® 80mg (Osimertinib) as a single daily dose until disease progression or unacceptable toxicity.

GENETIC

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)."

GENETIC

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"

Trial Locations (17)

13915

AP-HM Hôpital Nord Marseille, Marseille

14000

Crlcc Francois Baclesse, Caen

35033

Chru Pontchaillou, Rennes

37044

Chu Tours, Tours

38700

Chu Grenoble, La Tronche

44000

CHU de Nantes, Nantes

49033

CHU d'ANGERS, Angers

49300

CH de Cholet, Cholet

59037

Hôpital Calmette CHRU de Lille, Lille

67091

Chru Strasbourg, Strasbourg

68051

CH DU MOENCHSBERG - Hôpital Emile Muller, Mulhouse

72000

CH Le Mans, Le Mans

75005

Institut Curie, Paris

75970

AP-HP Hôpital Tenon, Paris

83056

Chits Ch Sainte Musse, Toulon

85925

CHD Vendée, La Roche-sur-Yon

94000

C H I Créteil, Créteil

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

lead

Nantes University Hospital

OTHER

NCT03865511 - MEchanisms of Resistance in EGFR Mutated Nonpretreated Advanced Lung Cancer Receiving OSimErtib | Biotech Hunter | Biotech Hunter