ClinicalTrials.gg
RecruitingNCT06247826RESAMEXUpdated Apr 29, 2026

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

An interventional study of Blood sampling in Non-small Cell Lung Cancer and EGFR Exon 20 Insertion Mutation, sponsored by Groupe Francais De Pneumo-Cancerologie. Recruiting at 18 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by Groupe Francais De Pneumo-Cancerologie · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 872 studies in Carcinoma, Non-Small-Cell Lung with a site in France — 170 open to participants now, 328 under way, 106 of them phase 3. Carcinoma, Non-Small-Cell Lung · France.

Planned enrollment
687th of 759
30 · median 190
Started
2024
with 62 others
No phase
58 of 872
14 open now
Primary completion
2026-07
later than 93 of 325 live
Registered
731st of 872
by date

Among the 872 studies in Carcinoma, Non-Small-Cell Lung with a site in France, this one is the 687th largest by planned enrollment of the 759 interventional ones, is one of 63 that started in 2024, is one of 58 with no phase, reaches primary completion later than 93 of the 325 other live ones, and was the 731st registered.

By phase

872 studies; the count open now beside each. This study's row is marked.

Phase 2241 · 25 open
Phase 3236 · 42 open
Phase 1125 · 26 open
Observational104 · 26 open
Phase 1/280 · 27 open
No phasethis study58 · 14 open
Phase 2/316 · 5 open
Phase 49 · 3 open
Other kind3 · 2 open

By the year they started

First in 1994; this study’s year is marked. 63 started in 2024.

Size and results

Median enrollment 190 across the 759 interventional studies, 151 across the 104 observational. Of the 512 that completed or were terminated, 257 (50%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 872 studies in Carcinoma, Non-Small-Cell Lung with a site in France, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Non-small Cell Lung Cancer
  • EGFR Exon 20 Insertion Mutation
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients receiving amivantamab in combination with another therapy;
  • Patients who do not consent to liquid at progression.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Experimental arm

    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

  • ProcedureBlood sampling

    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.

06

What researchers measure

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.

    Time frame: 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.

    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

07

Study locations

10 of 18 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2024 (actual). Primary completion is estimated for Jul 2026, 30 months after the start.

Of 343 non-industry interventional studies with no phase under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 98. This study's planned 30 months is below that.

Counting every sponsor, half of 359 studies reached it within 51 months; a quarter within 26 and three quarters within 97.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 11, 2024
First posted
Feb 8, 2024
StartActual
Jan 15, 2024
Primary completionEst.
Jul 30, 2026
CompletionEst.
Jul 30, 2026
Last update
Apr 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06247826
Lead sponsor
Groupe Francais De Pneumo-Cancerologie
Responsible party
Sponsor
First posted
Feb 8, 2024
Start date
Jan 15, 2024
Primary completion
Jul 30, 2026 (estimated)
Completion
Jul 30, 2026 (estimated)
Last update
Apr 29, 2026

Study contacts

Laurent GRELLIER
Contact
laurent.greillier@ap-hm.fr
+33 (0)4 91 96 59 01
Soizic Ferlandin
Contact
soizic_ferlandin@yahoo.fr
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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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