Spots Global Cancer Trial Database for Mechanisms of Resistance to Amivantamab in Patients With NSCLC With EGFR Exon 20 Insertion
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Trial Identification
Brief Title: Mechanisms of Resistance to Amivantamab in Patients With NSCLC With EGFR Exon 20 Insertion
Official Title: Mechanisms of Resistance to Amivantamab in Patients With NSCLC With EGFR Exon 20 Insertion
Study ID: NCT06247826
Interventions
Study Description
Brief Summary: The goal of this prospective, interventional study is to evaluate the mechanisms of acquired resistance to amivantamab monotherapy in patients with advanced NSCLC with EGFR ins20. The main question it aims to answer is: What are the mechanisms of acquired resistance to amivantamab monotherapy in this population of patients ? How anticipate the efficacy of subsequent systemic therapies ? After this information session, the participant will be asked to sign the study informed consent. A blood samples (2\*10 mL on ethylenediaminetetraacetic acid (EDTA)) will be taken at time of disease progression and will be sent for central liquid biopsy ctDNA analysis. If available, tumor tissue will also be sent for DNA NGS analysis.
Detailed Description: RESAMEX is a prospective study evaluating the mechanisms of acquired resistance to amivantamab monotherapy in patients with advanced NSCLC with EGFR ins20. Biological analysis will be performed on circulating tumor deoxyribonucleic acid (ctDNA) at the time of disease progression and on tumor tissue at the time of disease progression when available. * ctDNA : The extraction of the ctDNA will be performed in an automated way with the Promega RSC LV cfDNA kit on Maxwell platform. Sequencing will be performed on NextSeq500 platform with a panel of 208 genes (including 190 genes with full coverage of coding regions, and 11 genes with coverage of introns involved in translocations) covering 800 kpb and at a target depth of 8000 X. * Tissue : Deoxyribonucleic acid (DNA) next generation sequencing (NGS) will be performed on tumor biopsy (10 slides of 5 microns) . Samples will be sent for centralized analysis to Centre de Recherche en Cancérologie de Marseille (CRCM), 27 Bd Lei Roure, 13009 Marseille (Prof. Tomasini and Gwenaël Lumet), and will be stored at Centre de Ressources Biologiques de l'Assistance Publique Hôpitaux de Marseille (CRB AP-HM), 264 Rue Saint-Pierre, 13005 Marseille.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Oncologie Polyclinique Bordeaux Nord Aquitaine, Bordeaux, , France
Centre Hospitalier du Morvan, Brest, , France
Pneumologie Centre Hospitalier Intercommunal de Créteil, Creteil, , France
Oncologie, CLCC Dijon, Dijon, , France
Pneumologie, CHU Grenoble, Grenoble, , France
Pneumologie CH, Le Mans, , France
Oncologie thoracique Hôpital Nord, Marseille, , France
Oncologie, Centre Antoine Lacassagne, Nice, , France
Oncologie Institut Curie, Paris, , France
Hôpital Cochin, Paris, , France
Pneumologie, Hôpital Tenon, Paris, , France
Pneumologie Centre Hospitalier, Pau, , France
Pneumologie CHI Cornouaille, Quimper, , France
Hôpital Charles Nicolle, Rouen, , France
CHU La Réunion Site Nord, Saint-Denis, , France
CHU Hôpital Nord, Saint-Étienne, , France
CH Bretagne Atlantique, Vannes, , France
Pneumologie, Hôpital Mutualiste Resamut, Villeurbanne, , France
Contact Details
Name: Pascale Tomasini
Affiliation: Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques Hôpital Nord-APHM
Role: PRINCIPAL_INVESTIGATOR
Name: Maude Dupé-Pelletier
Affiliation: Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques Hôpital Nord-APHM
Role: PRINCIPAL_INVESTIGATOR
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