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Aktiv, aber nicht rekrutierendPHASE3INTERVENTIONELL

Eine Studie zu Lazertinib mit subkutanem Amivantamab im Vergleich zu intravenösem Amivantamab bei Teilnehmern mit epidermalem Wachstumsfaktor-Rezeptor (EGFR)-mutiertem fortgeschrittenem oder metastasiertem nicht-kleinzelligem Lungenkrebs

This study is looking at people with a type of advanced lung cancer called non-small cell lung cancer, which has specific genetic changes (EGFR mutations). We are comparing two ways to give a medicine called amivantamab. One way is the standard intravenous (into a vein) drip. The other is a new version of amivantamab given as an injection under the skin. The main goal is to see if this new injection is simpler and quicker to give, making it a better experience for patients and medical staff. We want to understand if it works just as well and is safe.

Auf einen Blick

Status
Aktiv, aber nicht rekrutierend
Phase
PHASE3
Sponsor
Janssen Research & Development, LLC
Einschreibeziel
418
Starten
05 Aug 2022
Geschätzte Fertigstellung
30. Juni 2027
Fortgeschrittener oder metastasierter nicht-kleinzelliger Lungenkrebs

Ergebnisse

Ergebnisse dieser Studie

Veröffentlicht February 2026

Die Ergebnisse dieser Studie wurden veröffentlicht.

Hauptausgang
For All Regions Other Than the European Union (EU) and Others Accepting Cycle 2 Day 1: Observed Serum Concentration (Ctrough) of Amivantamab at Steady State
Ctrough was the observed serum concentration of Amivantamab at steady state immediately prior to the next drug administration.
Vollständige Ergebnisse im Register

Worum geht es in dieser Studie?

This research study is about a type of advanced lung cancer called non-small cell lung cancer. Specifically, it's for people whose cancer has certain genetic changes, known as EGFR mutations. We're interested in improving how a vital medicine called amivantamab is given.

Currently, amivantamab is usually given to patients through a drip into a vein. This can take a while and sometimes isn't the most convenient for patients or doctors. The aim of this study is to test a new version of the medicine that can be given as an injection just under the skin. This new injection is designed to be much simpler and quicker to administer.

By comparing the injection with the current drip method, we want to find out if the new injection works just as well, is safe, and makes the treatment experience better for patients. We hope it can offer a more comfortable and efficient way for people to receive their treatment.

Wichtige Erkenntnisse

  • This study compares two ways to give advanced lung cancer medicine: drip vs. injection.
  • It's for people with a specific type of EGFR-mutated non-small cell lung cancer.
  • The goal is to find a simpler, quicker, and patient-friendly way to give treatment.
  • Participation includes regular clinic visits, blood tests, and scans.
  • You will receive either the drip or the experimental injection plus lazertinib.

Wer könnte berechtigt sein?

To join this study, you need to have a specific type of advanced non-small cell lung cancer that has certain genetic changes (called EGFR Exon 19 deletion or Exon 21 L858R mutation). Your cancer must have gotten worse after you've already had certain treatments, including osimertinib (or a similar medicine) and platinum-based chemotherapy.

You also need to be generally well enough to take part, meaning you can mostly look after yourself. The medical team will check if there's at least one part of your cancer that can be measured to see how well the treatment is working. Any side effects from previous treatments must have mostly cleared up.

Könnte diese Studie für Sie geeignet sein?

Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.

  1. Do you have advanced non-small cell lung cancer with specific EGFR mutations?
  2. Has your cancer progressed after treatments like osimertinib and chemotherapy?
  3. Are you generally well and able to mostly look after yourself (ECOG 0-1)?
  4. Have your previous treatment side effects mostly cleared up?
  5. Is there at least one area of your cancer that can be measured by scans?
Beantworten Sie jede Frage, um Ihr Ergebnis zu sehen.

Was beinhaltet die Teilnahme?

If you join this study, you will either receive the standard amivantamab medicine through a drip into your vein OR the new amivantamab injection under your skin, along with another medicine called lazertinib. You won't get to choose which group you are in; it will be decided randomly.

Throughout the study, you'll have regular hospital visits for your treatment, blood tests, scans (like CT scans) to check your progress, and health checks by doctors and nurses. These appointments will help the research team see how the treatment is working and if you have any side effects. The total length of your participation will depend on how you respond to the treatment and what the study doctors advise.

Potenzielle Risiken und Vorteile

Taking part in a study like this means you might receive a new way of taking a medicine that could be more convenient, but there's no guarantee the treatment will work for you or be better than what you've had before. There are also potential risks involved with any treatment; for example, you might experience side effects from the medicines, which the study team will discuss in detail with you. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (187)

  • City of Hope Duarte
    Verifizierte Postleitzahl
    Duarte, Vereinigte Staaten
  • City of Hope Orange County Lennar Foundation Cancer Center
    Verifizierte Postleitzahl
    Irvine, Vereinigte Staaten
  • City of Hope Long Beach Elm
    Verifizierte Postleitzahl
    Long Beach, Vereinigte Staaten
  • National Jewish Health
    Verifizierte Postleitzahl
    Denver, Vereinigte Staaten
  • Baptist Lynn Cancer Institute
    Verifizierte Postleitzahl
    Boca Raton, Vereinigte Staaten
  • Orlando Health
    Verifizierte Postleitzahl
    Orlando, Vereinigte Staaten
  • University of Kansas
    Verifizierte Postleitzahl
    Kansas City, Vereinigte Staaten
  • Universität von Michigan
    Verifizierte Postleitzahl
    Ann Arbor, Vereinigte Staaten
  • Astera Cancer Care
    Verifizierte Postleitzahl
    East Brunswick, United States
  • Rutgers Cancer Institute of New Jersey
    Verifizierte Postleitzahl
    New Brunswick, United States
  • NYU Langone Health Laura and Isaac Perlmutter Cancer Center
    Verifizierte Postleitzahl
    New York, Vereinigte Staaten
  • Montefiore Medical Center
    Verifizierte Postleitzahl
    The Bronx, United States

Häufige Fragen

What is EGFR-mutated lung cancer?

It's a type of lung cancer where the cancer cells have specific changes in a gene called EGFR, which can sometimes make the cancer grow.

What is amivantamab?

It's a medicine used to treat this type of lung cancer, designed to block the signals that make cancer cells grow.

What does 'subcutaneous' mean?

It means the medicine is given as an injection just under your skin, rather than directly into a vein.

What is 'lazertinib'?

Lazertinib is another medicine that researchers are studying alongside amivantamab for this type of lung cancer.

Wie lange wird die Studie dauern?

The length of your participation will depend on your individual response to the treatment and your doctor's advice.

Wie Sie mehr erfahren können

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