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

2026. április 24. frissítette: 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.

A tanulmány áttekintése

Állapot

Toborzás

Körülmények

Tanulmány típusa

Megfigyelő

Beiratkozás (Becsült)

100

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányozza a kapcsolattartók biztonsági mentését

Tanulmányi helyek

  • Franciaország
      • Aix-en-Provence, Franciaország, 13616
        • Toborzás
        • CH du Pays d Aix - Service des Maladies Respiratoires
        • Kapcsolatba lépni:
      • Bobigny, Franciaország, 93000
      • Bron, Franciaország, 69500
        • Aktív, nem toborzó
        • Hopital Louis Pradel
      • Caen, Franciaország, 14000
        • Aktív, nem toborzó
        • Pneumologie Centre François Baclesse
      • Créteil, Franciaország, 94010
      • Le Chesnay, Franciaország, 78157
        • Toborzás
        • Hôpital A. Mignot
        • Kapcsolatba lépni:
      • Lille, Franciaország, 59000
      • Lyon, Franciaország, 69373
      • Lyon, Franciaország, 69085
        • Toborzás
        • Pneumologie Hôpital privé Jean Mermoz
        • Kapcsolatba lépni:
      • Marseille, Franciaország, 13915
      • Nancy, Franciaország, 54000
        • Aktív, nem toborzó
        • CHRU de Nancy
      • Nice, Franciaország, 06149
        • Aktív, nem toborzó
        • Centre Antoine Lacassagne
      • Paris, Franciaország, 75005
        • Aktív, nem toborzó
        • Institut Curie
      • Pringy, Franciaország, 74374
      • Saint-Etienne, Franciaország, 42270
      • Saint-Pierre, Franciaország, 97410

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Felnőtt
  • Idősebb felnőtt

Egészséges önkénteseket fogad

Nem

Mintavételi módszer

Valószínűségi minta

Tanulmányi populáció

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).

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Kohorszok és beavatkozások

Csoport / Kohorsz
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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Investigator Progression Free Survival (Investigator PFS)
Időkeret: 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)
Időkeret: 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

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Baseline Clinical Characteristics
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

GFPC Investigation

Nyomozók

  • Kutatásvezető: Prof. Jean-Bernard Auliac, Service de Pneumologie - Centre Hospitalier Intercommunal de Créteil
  • Kutatásvezető: Dr Thomas Pierret, Service de Pneumologie - Hôpital Louis Pradel GH Est-HCL
  • Tanulmányi szék: Prof. Christos Chouaïd, Service de Pneumologie - Centre Hospitalier Intercommunal de Créteil

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2025. november 19.

Elsődleges befejezés (Becsült)

2027. november 19.

A tanulmány befejezése (Becsült)

2027. november 19.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. április 20.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. április 24.

Első közzététel (Tényleges)

2026. május 1.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. május 1.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. április 24.

Utolsó ellenőrzés

2026. április 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

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

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