Mechanisms of Resistance to Amivantamab in Patients With NSCLC With EGFR Exon 20 Insertion

NCT06247826 | Recruiting

• 1 other identifier: GFPC 06-2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 18

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.

Conditions

Non-small Cell Lung Cancer; EGFR Exon 20 Insertion Mutation

Outcome Measures

Primary Outcomes (1)

• Percentage of molecular alterations

  Percentage of molecular alterations found at the time of disease progression on amivantamab monotherapy in patients with advanced NSCLC with EGFR ins20.

  At disease progression on a period up to 18 months at maximum

Secondary Outcomes (1)

• Progression Free Survival

  From the date of first dose of treatment received until the date of the first documented disease progression according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 or to death from any cause, whichever came first, assessed up to 18 months

Study Arms (1)

Experimental arm

EXPERIMENTAL

Patients presenting advanced NSCLC with EGFR ins20 already treated with amivantamab as monotherapy in France under Temporary Use Authorisation or Early Access Program who will accept to provide blood samples at disease progression.

Procedure: Blood sampling

Interventions

Blood sampling PROCEDURE

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.

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with advanced NSCLC with EGFR ins20 receiving amivantamab as monotherapy in France under ATU or EAP;
• Age ≥ 18 years;
• Histologically confirmed advanced NSCLC (metastatic or locally advanced unresectable and not suitable for definitive radiotherapy) with EGFR ins20;
• Patients included will be required to sign an informed consent form to collect blood samples (liquid biopsy) and tissue biopsy when available at progression on amivantamab;
• Confirmed progression on amivantamab according to RECIST 1.1;
• Patient enrolled in the french National Health Insurance program or with a third- party payer.

You may not qualify if:

• Patients receiving amivantamab in combination with another therapy;
• Patients who do not consent to liquid biopsy at progression.

Sponsors & Collaborators

• Groupe Francais De Pneumo-Cancerologie: lead

Study Sites (18)

Oncologie Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33000, France

NOT YET RECRUITING

Centre Hospitalier du Morvan

Brest, 29200, France

RECRUITING

Pneumologie Centre Hospitalier Intercommunal de Créteil

Créteil, 94010, France

RECRUITING

Oncologie, CLCC Dijon

Dijon, 21000, France

NOT YET RECRUITING

Pneumologie, CHU Grenoble

Grenoble, 38043, France

RECRUITING

Pneumologie CH

Le Mans, 72000, France

NOT YET RECRUITING

Oncologie thoracique Hôpital Nord

Marseille, 13915, France

RECRUITING

Oncologie, Centre Antoine Lacassagne

Nice, 06149, France

WITHDRAWN

Oncologie Institut Curie

Paris, 75005, France

NOT YET RECRUITING

Hôpital Cochin

Paris, 75014, France

RECRUITING

Pneumologie, Hôpital Tenon

Paris, 75970, France

RECRUITING

Pneumologie Centre Hospitalier

Pau, 64000, France

NOT YET RECRUITING

Pneumologie CHI Cornouaille

Quimper, 02900, France

NOT YET RECRUITING

Hôpital Charles Nicolle

Rouen, 76031, France

RECRUITING

CHU La Réunion Site Nord

Saint-Denis, 97411, France

RECRUITING

CHU Hôpital Nord

Saint-Etienne, 42055, France

RECRUITING

CH Bretagne Atlantique

Vannes, 56017, France

RECRUITING

Pneumologie, Hôpital Mutualiste Resamut

Villeurbanne, 69100, France

NOT YET RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Pascale Tomasini

  Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques Hôpital Nord-APHM

  PRINCIPAL INVESTIGATOR

• Maude Dupé-Pelletier

  Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques Hôpital Nord-APHM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent GRELLIER

CONTACT

+33 (0)4 91 96 59 01; laurent.greillier@ap-hm.fr

Soizic Ferlandin

CONTACT

soizic_ferlandin@yahoo.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: February 8, 2024
• Study Start: January 15, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

FR (18)