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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.

במבט חטוף

סטטוס
פעיל אך לא מגייס
שלב
שלב 3
נותן חסות
יאנסן מחקר ופיתוח, LLC
יעד הרשמה
418
התחל
05 Aug 2022
השלמה משוערת
30 יוני 2027

תוצאות

תוצאות ממחקר זה

פורסם February 2026

תוצאות המחקר פורסמו.

תוצאה ראשית
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.
תוצאות מלאות ברישום

על מה המחקר הזה?

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.

נקודות עיקריות

  • 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.

מי עשוי להיות זכאי?

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.

האם מחקר זה יכול להתאים לך?

ענה על השאלות המהירות הללו כדי לבדוק אם אתה עשוי להיות זכאי. זהו מדריך בלבד — צוות המחקר מקבל את ההחלטה הסופית.

  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?
ענה על כל שאלה כדי לראות את התוצאה שלך.

מה כרוך בהשתתפות?

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.

סיכונים ותועלות פוטנציאליים

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
    מיקוד מאומת
    דוארטה, ארצות הברית
  • City of Hope Orange County Lennar Foundation Cancer Center
    מיקוד מאומת
    אירוויין, ארצות הברית
  • City of Hope Long Beach Elm
    מיקוד מאומת
    לונג ביץ', ארצות הברית
  • National Jewish Health
    מיקוד מאומת
    דנוור, ארצות הברית
  • Baptist Lynn Cancer Institute
    מיקוד מאומת
    בוקה רטון, ארצות הברית
  • Orlando Health
    מיקוד מאומת
    אורלנדו, ארצות הברית
  • University of Kansas
    מיקוד מאומת
    קנזס סיטי, ארצות הברית
  • אוניברסיטת מישיגן
    מיקוד מאומת
    אן ארבור, ארצות הברית
  • Astera Cancer Care
    מיקוד מאומת
    East Brunswick, United States
  • Rutgers Cancer Institute of New Jersey
    מיקוד מאומת
    New Brunswick, United States
  • NYU Langone Health Laura and Isaac Perlmutter Cancer Center
    מיקוד מאומת
    ניו יורק, ארצות הברית
  • מרכז רפואי מונטיפיורי
    מיקוד מאומת
    הברונקס, ארצות הברית

שאלות נפוצות

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.

כמה זמן יימשך המחקר?

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

כיצד לגלות עוד

תמיד התייעץ עם רופא המשפחה או המומחה שלך לפני שתחליט להשתתף במחקר.

דיון

דיון קהילתי

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