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Aktiv men inte rekryterandeFAS3INTERVENTIONELL

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.

Överblick

Status
Aktiv men inte rekryterande
Fas
FAS3
Sponsor
Janssen Forskning & Utveckling, LLC
Inskrivningsmål
418
Starta
05 Aug 2022
Beräknad slutförande
30 jun 2027

Resultat

Resultat från denna studie

Publicerad Februari 2026

Resultaten har publicerats för denna studie.

Primärt resultat
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.
Fullständiga resultat i registret

Vad handlar denna studie om?

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.

Viktiga punkter

  • 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.

Vem kan vara berättigad?

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.

Kan denna studie passa dig?

Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.

  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?
Svara på varje fråga för att se ditt resultat.

Vad innebär deltagande?

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.

Potentiella risker och fördelar

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
    Verifierat postnummer
    Duarte, USA
  • City of Hope Orange County Lennar Foundation Cancer Center
    Verifierat postnummer
    Irvine, USA
  • City of Hope Long Beach Elm
    Verifierat postnummer
    Long Beach, USA
  • National Jewish Health
    Verifierat postnummer
    Denver, USA
  • Baptist Lynn Cancer Institute
    Verifierat postnummer
    Boca Raton, Förenta staterna
  • Orlando Hälsa
    Verifierat postnummer
    Orlando, USA
  • University of Kansas
    Verifierat postnummer
    Kansas City, USA
  • University of Michigan
    Verifierat postnummer
    Ann Arbor, USA
  • Astera Cancer Care
    Verifierat postnummer
    East Brunswick, USA
  • Rutgers Cancer Institute of New Jersey
    Verifierat postnummer
    New Brunswick, USA
  • NYU Langone Health Laura and Isaac Perlmutter Cancer Center
    Verifierat postnummer
    New York, USA
  • Montefiore medicinska centrum
    Verifierat postnummer
    The Bronx, USA

Vanliga frågor

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.

Hur länge kommer studien att pågå?

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

Hur du får reda på mer

Prata alltid med din läkare eller specialist innan du bestämmer dig för att delta i en studie.

Diskussion

Gemenskapsdiskussion

Drivs av vårt forum på community.patient.info. Var vänlig och respektfull — detta är inte medicinsk rådgivning.