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Attivo ma non reclutanteFASE3INTERVENTISTICO

A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer

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.

A colpo d'occhio

Stato
Attivo ma non reclutante
Fase
FASE3
Sponsor
Janssen Ricerca & Sviluppo, LLC
Obiettivo di iscrizione
418
Inizio
05 Aug 2022
Completamento stimato
30 Giugno 2027

Risultati

Risultati di questo studio

Pubblicato February 2026

I risultati di questo studio sono stati pubblicati.

Risultato principale
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.
Risultati completi nel registro

Di cosa tratta questo studio?

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.

Punti chiave

  • 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.

Chi può essere idoneo?

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.

Questo studio potrebbe fare al caso tuo?

Rispondi a queste domande rapide per vedere se potresti essere idoneo. Questo è solo una guida — il team di ricerca prende la decisione finale.

  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?
Rispondi a ogni domanda per vedere il tuo risultato.

Cosa comporta la partecipazione?

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.

Rischi e benefici potenziali

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
    Codice postale verificato
    Duarte, Stati Uniti
  • City of Hope Orange County Lennar Foundation Cancer Center
    Codice postale verificato
    Irvine, Stati Uniti
  • City of Hope Long Beach Elm
    Codice postale verificato
    Long Beach, Stati Uniti
  • Salute Ebraica Nazionale
    Codice postale verificato
    Denver, Stati Uniti
  • Baptist Lynn Cancer Institute
    Codice postale verificato
    Boca Raton, United States
  • Orlando Health
    Codice postale verificato
    Orlando, Stati Uniti
  • University of Kansas
    Codice postale verificato
    Kansas City, Stati Uniti
  • Università del Michigan
    Codice postale verificato
    Ann Arbor, Stati Uniti
  • Astera Cancer Care
    Codice postale verificato
    East Brunswick, United States
  • Rutgers Cancer Institute of New Jersey
    Codice postale verificato
    New Brunswick, United States
  • NYU Langone Health Laura and Isaac Perlmutter Cancer Center
    Codice postale verificato
    New York, Stati Uniti
  • Centro Medico Montefiore
    Codice postale verificato
    Il Bronx, Stati Uniti

Domande comuni

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.

Quanto durerà lo studio?

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

Come saperne di più

Parla sempre con il tuo medico di base o specialista prima di decidere di partecipare a uno studio.

Discussione

Discussione della comunità

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