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Observational Multicenter Study in Patients Receiving Chemotherapy and Amivantamab for Metastatic Non-small Cell Lung Cancer (OMAE)

24 avril 2026 mis à jour par: GFPC Investigation

Observational Multicenter Study in Patients Receiving Chemotherapy and Amivantamab for Metastatic Non-small Cell Lung Cancer as Part of an Early Access Program

The purpose of this observational study is to understand how well a treatment combining chemotherapy and amivantamab works in real life, and how safe it is, in adults with metastatic non-small cell lung cancer (NSCLC) who have certain EGFR gene mutations.

The study includes two groups of people:

  • Group A: people with an EGFR exon 20 insertion who receive amivantamab together with platinum-based chemotherapy as their first treatment, through an early access program.
  • Group B: people with an EGFR exon 19 or exon 21 mutation who receive amivantamab with platinum-based chemotherapy after having been treated with osimertinib (with or without chemotherapy), also through an early access program.

The main question the study wants to answer is:

How long can the combination of amivantamab and chemotherapy keep the cancer from coming back or getting worse in these two groups of people?

People already receiving amivantamab and chemotherapy for NSCLC through an early access program may be included. They will continue to be followed by their usual oncologist as part of their normal medical care. The study will simply collect their medical information from March 21, 2024 to October 21, 2025.

No extra tests or procedures are required. This is an observational study, carried out by the GFPC and partner centers in France.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Type d'étude

Observationnel

Inscription (Estimé)

100

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • France
      • Aix-en-Provence, France, 13616
        • Recrutement
        • CH du Pays d Aix - Service des Maladies Respiratoires
        • Contact:
      • Bobigny, France, 93000
      • Bron, France, 69500
        • Actif, ne recrute pas
        • Hopital Louis Pradel
      • Caen, France, 14000
        • Actif, ne recrute pas
        • Pneumologie Centre François Baclesse
      • Créteil, France, 94010
      • Le Chesnay, France, 78157
      • Lille, France, 59000
      • Lyon, France, 69373
      • Lyon, France, 69085
        • Recrutement
        • Pneumologie Hôpital privé Jean Mermoz
        • Contact:
      • Marseille, France, 13915
      • Nancy, France, 54000
        • Actif, ne recrute pas
        • CHRU de Nancy
      • Nice, France, 06149
        • Actif, ne recrute pas
        • Centre Antoine Lacassagne
      • Paris, France, 75005
        • Actif, ne recrute pas
        • Institut Curie
      • Pringy, France, 74374
      • Saint-Etienne, France, 42270
      • Saint-Pierre, France, 97410

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

Principal investigator of GFPC or partner centers will identify consecutive patients eligible for the inclusion from the patient population of their center (public hospital or private clinics).

La description

Inclusion Criteria:

  • Patient over 18 years old
  • Cohort A: Patient with metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion treated with amivantamab-platimum based chemotherapy via an early access program in first line setting.
  • Cohort B: Patient with metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 19 or 21 treated with amivantamab-platimum based chemotherapy post osimertinib (with or without chemotherapy) via an early access program.
  • Patient covered by the French National Health Insurance system or by an approved third-party payer
  • Patient who does not object to the collection of their personal data for research purposes (an information sheet will be provided to all living participants; for deceased participants, documented non-opposition in the medical record is not required)

Exclusion Criteria:

  • Patient placed under legal guardianship or subject to a protective legal measure
  • Patient who explicitly refuses the collection or use of their personal data for research purposes
  • Patient not enrolled, managed, or followed at the investigating site by a qualified site investigator

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Cohort A
People with an EGFR exon 20 insertion who receive amivantamab together with platinum-based chemotherapy as their first treatment, through an early access program.
Cohort B
People with an EGFR exon 19 or exon 21 mutation who receive amivantamab with platinum-based chemotherapy after having been treated with osimertinib (with or without chemotherapy), also through an early access program.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Investigator Progression Free Survival (Investigator PFS)
Délai: From the date of first dose of combination treatment received until the date of the first documented disease progression or to death from any cause, whichever comes first, assessed for a 2-year-period maximum

The Investigator Progression Free Survival is defined as the time between chemotherapy and amivantamab combination treatment initiation date and date of first documentation of disease progression defined by the Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 progression or death for any cause, whichever comes first.

Disease progression will be evaluated according to (RECIST) 1.1 assessed locally. Frequency of this assessment is let at the investigator 's discretion as per local practices.

The participants will be followed until disease progression or death for any cause. Patients without an event at the time of analysis will be censored at the date of their last tumor assessment.
From the date of first dose of combination treatment received until the date of the first documented disease progression or to death from any cause, whichever comes first, assessed for a 2-year-period maximum
Independent Panel Progression Free Survival (Independent Panel PFS)
Délai: From the date of first dose of treatment received until the date of the first documented disease progression or to death from any cause, whichever comes first, assessed for a 2-year-period maximum

The Independent Panel Progression Free Survival is defined as the time between chemotherapy and amivantamab combination treatment initiation date and date of first documentation of disease progressionnt defined by the Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 progression or death for any cause, whichever comes first.

Disease progression will be evaluated according to (RECIST) 1.1 centrally by an independent panel based on images provided by the site.

The participants will be followed until disease progression or death for any cause. Patients without an event at the time of analysis will be censored at the date of their last tumor assessment.
From the date of first dose of treatment received until the date of the first documented disease progression or to death from any cause, whichever comes first, assessed for a 2-year-period maximum

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Baseline Clinical Characteristics
Délai: At Baseline visit, on a maximum period of 12 months
Baseline Clinical Characteristics as defined by baseline patient clinical characteristics (e.g. medical history, comorbidity, potential professional exposure, past history of cancer or auto-immune disease, smoking status, NSCLC or SCLC characteristics)
At Baseline visit, on a maximum period of 12 months
Overall Survival (OS)
Délai: Continuously from treatment start until death, withdrawal of consent, loss to follow up, or end of study, whichever occurs first, for a 2-year-period maximum
OS is defined as the time from date of initiation of treatment combination initiation to date of death from any cause. Patients alive (or lost to follow up) at the time of analysis will be censored at the date they were last known to be alive.
Continuously from treatment start until death, withdrawal of consent, loss to follow up, or end of study, whichever occurs first, for a 2-year-period maximum
Investigator Objective Response Rate (Investigator ORR)
Délai: From the date of first dose of treatment combination received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum
ORR is defined as the proportion of patients with complete response (CR) or partial response (PR) as the best response during the study according to RECIST 1.1 criteria based on tumoral assessment performed by the investigator using thorax-abdominal-pelvic and brain CT scans. The frequency of the tumor assessments will follow the site practices.
From the date of first dose of treatment combination received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum
Independent Panel Objective Response Rate (Independent Panel ORR)
Délai: From the date of first dose of treatment combination received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum
ORR is defined as the proportion of patients with complete response (CR) or partial response (PR) as the best response during the study according to RECIST 1.1 criteria based on tumoral assessment performed by the independent panel based on thorax-abdominal-pelvic and brain CT scans provided by the sites.
From the date of first dose of treatment combination received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum
Adverse events
Délai: From the combination treatment start date up to a 2-year-period maximum
All adverse events experienced by the participants, whatever the grades of toxicity, will be collected according to CTCAE v5.0 (common terminology criteria for adverse events).
From the combination treatment start date up to a 2-year-period maximum
Treatment duration
Délai: From the combination treatment start date up to a 2-year-period maximum
Treatment duration as defined from the date of the first dose of of chemotherapy and amivantamab combination up to the date of the last dose of the combination received by the patient.
From the combination treatment start date up to a 2-year-period maximum
Reasons for discontinuation
Délai: From the combination treatment start date up to a 2-year-period maximum
Reason for discontinuation is defined by the reason for permanent discontinuation of combination treatment as recorded by the investigator (e.g. : disease progression, adverse event, lack of efficacy, patient decision, physician decision, other)
From the combination treatment start date up to a 2-year-period maximum
Site of progression after treatment combination administration
Délai: Assessed at each tumor evaluation scheduled as per local practice, from first dose of combination therapy until end of treatment or study completion, whichever occurs first for a 2-year-period maximum
Site of disease progression after combination therapy is defined as the anatomical site(s) of first documented disease progression occurring after initiation of the combination treatment, as assessed by the investigator according to the study specified response criteria (e.g., RECIST, disease specific criteria). The site of progression will be categorized (e.g., target lesions, non target lesions, new lesions; organ specific sites such as lung, liver, bone, CNS, lymph nodes, primary tumor, etc.).
Assessed at each tumor evaluation scheduled as per local practice, from first dose of combination therapy until end of treatment or study completion, whichever occurs first for a 2-year-period maximum
Description of Post-progression type of treatments
Délai: From date of first lung cancer treatment administration for a 2-year-period maximum
Post-progression treatments received after documented disease progression will be collected and categorized. Data will include the type of therapy administered (e.g., systemic anticancer therapy, radiotherapy, surgery, supportive or palliative care). This measure describes subsequent lines of treatment and supports interpretation of survival outcomes.
From date of first lung cancer treatment administration for a 2-year-period maximum
Post-progression Progression Free Survival (ppPFS)
Délai: Assessed at each site visit scheduled as per local practice, from initiation of the first post-progression treatment until documented progression, death, end of treatment, or study completion, whichever occurs first, for a 2-year-period maximum
Post progression Progression Free Survival is defined as the time from the initiation date of the first post progression systemic anti cancer treatment to the date of the first documented disease progression (per local practice/standard criteria) or death from any cause, whichever occurs first.
Assessed at each site visit scheduled as per local practice, from initiation of the first post-progression treatment until documented progression, death, end of treatment, or study completion, whichever occurs first, for a 2-year-period maximum
Treatment outcomes by patients' baseline and disease characteristics
Délai: Assessed at each site visit scheduled as per local practice, from first dose of combination therapy until end of treatment or study completion, whichever occurs first for a 2-year-period maximum

Treatment outcomes by patients' baseline and disease characteristics defined as the comparison of :

  • Efficacy outcomes (PFS)
  • Safety outcomes (incidence and grade of adverse events under treatment) across predefined patient subgroups (e.g., age, performance status, metastatic sites, prior lines of therapy, biomarkers).
Assessed at each site visit scheduled as per local practice, from first dose of combination therapy until end of treatment or study completion, whichever occurs first for a 2-year-period maximum
Investigator Central Nervous System Objective Response Rate (Investigator CNS ORR)
Délai: From the date of first dose of treatment combination received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum
Investigator ORR CNS is defined as the proportion of patients with complete response (CR) or partial response (PR) as the best response during the study according to RECIST 1.1 criteria assessed by the investigator based preferentially on tumoral assessment performed by cerebral imaging every 12 weeks on patients with brain metastasis at diagnostic.
From the date of first dose of treatment combination received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum
Independent Panel Central Nervous System Objective Response Rate (Independent Panel CNS ORR)
Délai: From the date of first dose of treatment combination received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum
Independent Panel ORR CNS is defined as the proportion of patients with complete response (CR) or partial response (PR) as the best response during the study according to RECIST 1.1 criteria assessed by the independent panel based on tumoral assessments performed by the site on patients with brain metastasis at diagnostic.
From the date of first dose of treatment combination received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum
Investigator Central Nervous System Progression Free Survival (Investigator CNS PFS)
Délai: From the date of first dose of treatment received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum

Investigator PFS CNS is defined as the time between chemotherapy and amivantamab combination treatment initiation date and date of first documentation of disease progression date defined by the Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 progression or death for any cause, whichever comes first.

Disease progression will be evaluated according to (RECIST) 1.1 assessed by the investigator based preferentially on tumoral assessment performed by cerebral imaging every 12 weeks on patients with brain metastasis at diagnostic.
From the date of first dose of treatment received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum
Independent Panel Central Nervous System Progression Free Survival (Independent Panel CNS PFS)
Délai: From the date of first dose of treatment received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum

Independent Panel PFS CNS is defined as the time between chemotherapy and amivantamab combination treatment initiation date and date of first documentation of disease progression defined by the Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 progression or death for any cause, whichever comes first.

Disease progression will be evaluated according to (RECIST) 1.1 assessed by the independent panel based preferentially on tumoral assessment performed by cerebral imaging every 12 weeks on patients with brain metastasis at diagnostic.
From the date of first dose of treatment received until the date of the first documented disease progression according to RECIST 1.1 or to death from any cause, whichever comes first, assessed for a 2-year-period maximum
Central Nervous System Overall Survival (CNS OS)
Délai: Continuously from treatment start until death, withdrawal of consent, loss to follow up, or end of study, whichever occurs first, for a 2-year-period maximum
OS CNS is defined as the time from date of initiation of treatment combination initiation to date of death from any cause on patients with brain metastasis at diagnostic.
Continuously from treatment start until death, withdrawal of consent, loss to follow up, or end of study, whichever occurs first, for a 2-year-period maximum
Performance status
Délai: At Baseline visit, on a maximum period of 12 months
Performance status will be assessed at baseline using the validated scale called Eastern Cooperative Oncology Group [ECOG] Performance Status. The measure captures the participant's level of functional impairment and ability to carry out daily activities. Scores will be recorded as defined by the selected scale.
At Baseline visit, on a maximum period of 12 months
Age of the patient at Baseline
Délai: At Baseline visit, on a maximum period of 12 months
Age of participants will be recorded at baseline. Age will be collected in years. This measure characterizes the study population and supports demographic and subgroup analyses.
At Baseline visit, on a maximum period of 12 months
Body weight at Baseline
Délai: At Baseline visit, on a maximum period of 12 months
Body weight will be collected at baseline. Weight will be recorded in kilograms using a calibrated scale. This measure characterizes the study population and may support safety, dosing, or subgroup analyses.
At Baseline visit, on a maximum period of 12 months
Body mass index at Baseline
Délai: At Baseline visit, on a maximum period of 12 months
Body Mass Index (BMI) will be calculated at baseline using measured weight and height. BMI will be expressed in kg/m². This measure characterizes the study population and may support safety, or subgroup analyses.
At Baseline visit, on a maximum period of 12 months
Description of the number of cycles per post-progression treatments
Délai: From date of first lung cancer treatment administration for a 2-year-period maximum
The number of treatment cycles administered after documented disease progression will be collected for each participant. This measure captures the extent of post-progression therapy and supports interpretation of subsequent treatment exposure.
From date of first lung cancer treatment administration for a 2-year-period maximum
Description of the duration of each post-progression treatment
Délai: From date of the first lung cancer treatment administration for a 2-year-period maximum
The duration of each post-progression treatment will be recorded from the start date to the end date of the administered therapy. This measure characterizes the length of exposure to subsequent treatments following documented disease progression.
From date of the first lung cancer treatment administration for a 2-year-period maximum

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

GFPC Investigation

Les enquêteurs

  • Chercheur principal: Prof. Jean-Bernard Auliac, Service de Pneumologie - Centre Hospitalier Intercommunal de Créteil
  • Chercheur principal: Dr Thomas Pierret, Service de Pneumologie - Hôpital Louis Pradel GH Est-HCL
  • Chaise d'étude: Prof. Christos Chouaïd, Service de Pneumologie - Centre Hospitalier Intercommunal de Créteil

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

19 novembre 2025

Achèvement primaire (Estimé)

19 novembre 2027

Achèvement de l'étude (Estimé)

19 novembre 2027

Dates d'inscription aux études

Première soumission

20 avril 2026

Première soumission répondant aux critères de contrôle qualité

24 avril 2026

Première publication (Réel)

1 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 avril 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • OMAE GFPC 02-2024
  • CNRIPH National number (Autre identifiant: 2024-A01205-42)
  • CPP (Autre identifiant: 25.03484.000555)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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