Non-small Cell Lung CancerRESAMEXNCT06247826
Mechanisms of Resistance to Amivantamab in Patients With NSCLC With EGFR Exon 20 Insertion
A study testing Blood sampling in people with Non-small Cell Lung Cancer and EGFR Exon 20 Insertion Mutation, run by Groupe Francais De Pneumo-Cancerologie at 18 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, EGFR Exon 20 Insertion Mutation
- What is being tested?
- Blood sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 18 sitesFrance
- Study dates
- 15 Jan 2024to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients receiving amivantamab in combination with another therapy;
- Patients who do not consent to liquid biopsy at progression.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Soizic Ferlandin contact
18 sites in 1 country
France18 sites, 17 recruiting
- Not yet recruiting
Oncologie Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33000
Camille MAZZA, c.mazza@bordeauxnord.com
- Recruiting
Centre Hospitalier du Morvan
Brest, 29200
Renaud DESCOURT, PhD, +33 298223827, renaud.descourt@chu-brest.fr
Renaud DESCOURT, PhD
- Recruiting
Pneumologie Centre Hospitalier Intercommunal de Créteil
Créteil, 94010
Jean-Bernard AULIAC, jean-bernard.auliac@chicreteil.fr
Jean-Bernard AULIAC
- Not yet recruiting
Oncologie, CLCC Dijon
Dijon, 21000
Loick GALLAND, lgalland@cgfl.fr
- Recruiting
Pneumologie, CHU Grenoble
Grenoble, 38043
Anne Claire TOFFART, atoffart@chu-grenoble.fr
- Not yet recruiting
Pneumologie CH
Le Mans, 72000
Olivier MOLINIER, omolinier@ch-lemans.fr
- Recruiting
Oncologie thoracique Hôpital Nord
Marseille, 13915
Pascale Tomasini, pascale.tomasini@ap-hm.fr
- Withdrawn
Oncologie, Centre Antoine Lacassagne
Nice, 06149
- Not yet recruiting
Oncologie Institut Curie
Paris, 75005
Elisa Gobbini, elisa.gobbini@curie.fr
- Recruiting
Hôpital Cochin
Paris, 75014
Marie WISLEZ, marie.wislez@aphp.fr
- Recruiting
Pneumologie, Hôpital Tenon
Paris, 75970
Antony CANELLAS, anthony.canellas@aphp.fr
- Not yet recruiting
Pneumologie Centre Hospitalier
Pau, 64000
Aldo RENAULT, also.renault@ch-pau.fr
- Not yet recruiting
Pneumologie CHI Cornouaille
Quimper, 02900
Michel ANDRE, michel.andré@ch-cornouaille.fr
- Recruiting
Hôpital Charles Nicolle
Rouen, 76031
Florian GUISIER, florian.guisier@chu-rouen.fr
Florian GUISIER
- Recruiting
CHU La Réunion Site Nord
Saint-Denis, 97411
Diane MOREAU, diane.moreau@chu-reunion.fr
Diane MOREAU
- Recruiting
CHU Hôpital Nord
Saint-Etienne, 42055
Sophie BAYLE-BLEUEZ, sophie.bayle@chu-st-etienne.fr
Sophie BAYLE-BLEUEZ
- Recruiting
CH Bretagne Atlantique
Vannes, 56017
Gonzague DE CHABOT, gonzague.dechabot@ch-bretagne-atlantique.fr
- Not yet recruiting
Pneumologie, Hôpital Mutualiste Resamut
Villeurbanne, 69100
Jean-Marc DOT, j.dot@resamut.fr
About this study
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.
Read the 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.
- Being tested
- Blood sampling
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At disease progression on a period up to 18 months at maximum
Secondary outcomes (1)
Progression Free Survival
Progression free survival with the first subsequent therapy after amivatamab, defined as the time from first dose to first documentation of objective disease progression according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 or to death from any cause.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start15 Jan 2024
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Francais De Pneumo-Cancerologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascale Tomasini, Principal investigator, Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques Hôpital Nord-APHMMaude Dupé-Pelletier, Principal investigator, Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques Hôpital Nord-APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247826
- Sponsor's protocol ID
- GFPC 06-2023
- Acronym
- RESAMEX
- Status last verified
- Apr 2026
- First submitted
- 11 Jan 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Resistance to Amivantamab in Patients With NSCLC With EGFR Exon 20 Insertion
- ClinicalTrials.gov ID
- NCT06247826
- Acronym / sponsor ID
- RESAMEX / GFPC 06-2023
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Groupe Francais De Pneumo-CancerologieUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Procedure: Blood samplingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (2 listed)
- Patients receiving amivantamab in combination with another therapy;
- Patients who do not consent to liquid biopsy at progression.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood 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. | Procedure or surgery | Experimental arm |
Primary outcome
Percentage of molecular alterations
Time frame: At disease progression on a period up to 18 months at maximum
Percentage of molecular alterations found at the time of disease progression on amivantamab monotherapy in patients with advanced NSCLC with EGFR ins20.
1 secondary outcome
Progression Free Survival
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Soizic Ferlandin contact
Pascale Tomasini principal investigator
Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques Hôpital Nord-APHM
Maude Dupé-Pelletier principal investigator
Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques Hôpital Nord-APHM
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Non-small Cell Lung Cancer and EGFR Exon 20 Insertion Mutation, run by Groupe Francais De Pneumo-Cancerologie at 18 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurent GRELLIER (+33 (0)4 91 96 59 01, laurent.greillier@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of molecular alterations (time frame: At disease progression on a period up to 18 months at maximum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.