Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06247826
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-01-11
Brief Title:
Mechanisms of Resistance to Amivantamab in Patients With NSCLC With EGFR Exon 20 Insertion
Sponsor:
Groupe Francais De Pneumo-Cancerologie
Organization:
Groupe Francais De Pneumo-Cancerologie
Study Overview
Official Title:
Mechanisms of Resistance to Amivantamab in Patients With NSCLC With EGFR Exon 20 Insertion
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESAMEX
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 210 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
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 210 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 lAssistance Publique Hôpitaux de Marseille CRB AP-HM 264 Rue Saint-Pierre 13005 Marseille
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 lAssistance Publique Hôpitaux de Marseille CRB AP-HM 264 Rue Saint-Pierre 13005 Marseille
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None