A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions
This research study is about a kind of lung cancer that has spread, called non-small cell lung cancer, specifically if it has a particular genetic change called an 'EGFR Exon 20 insertion'. Doctors want to find out if adding a new drug, amivantamab, to the usual chemotherapy (carboplatin and pemetrexed) works better than chemotherapy by itself. The main goal is to see if the cancer can be stopped from growing for longer. This is a Phase 3 study, meaning it's a large trial comparing the new approach to the standard treatment to see if it's more effective and safe for patients.
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Resultados
Resultados de este estudio
Publicado May 2024Se han publicado los resultados de este estudio.
¿De qué trata este estudio?
This study is for people who have advanced or metastatic non-small cell lung cancer (NSCLC). This means the cancer has grown into nearby tissues or spread to other parts of the body. Doctors are particularly interested in NSCLC that has a specific genetic change, or 'mutation', called an EGFR Exon 20 insertion. This mutation can make the cancer behave differently and sometimes respond less well to common treatments.
The main aim of this study is to compare two treatment approaches. One group of patients will receive a combination of a new drug called amivantamab along with standard chemotherapy (carboplatin and pemetrexed). The other group will receive the standard chemotherapy alone. By comparing these two groups, researchers want to see if adding amivantamab helps to stop the cancer from growing for a longer period.
This is a 'Phase 3' study, which is a big step in testing new treatments. It means the treatment has already been tested in smaller groups and shown some promise. Now, it's being compared to the best available treatment to see if it's better overall. The results of studies like this help doctors understand which treatments are most effective for different types of cancer.
Puntos clave
- This study compares a new drug combination to standard chemotherapy for specific lung cancer.
- It's for advanced non-small cell lung cancer with a particular genetic change (EGFR Exon 20 insertion).
- The main goal is to see if the new combination stops cancer growth for longer.
- Participation involves regular hospital visits, treatments, and tests.
- You might receive the new combination or standard chemotherapy.
¿Quién puede ser elegible?
To join this study, you would need to have been diagnosed with advanced or metastatic non-small cell lung cancer that has a specific genetic change called an EGFR Exon 20 insertion. Doctors would need to confirm this from a tissue sample. You also need to have cancer that can be measured and tracked by scans.
Your general health and how well you can do daily activities are also important. For instance, your doctor will check your 'performance status', which is a way of saying you're generally well enough to take part. Women who could become pregnant would need to have regular pregnancy tests and use effective birth control throughout the study.
There are also reasons why you might not be able to join. For example, if you have other types of lung cancer at the same time, or if your cancer has spread to your brain in a way that isn't stable. Certain existing lung conditions, like interstitial lung disease, or allergies to the study drugs or related medications (like Vitamin B12 or folic acid) would also mean you couldn't take part.
¿Podría este estudio ser adecuado para ti?
Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.
- Do I have advanced or metastatic non-small cell lung cancer?
- Has my cancer been tested for an 'EGFR Exon 20 insertion' mutation, and does it have one?
- Is my cancer measurable on scans?
- Am I generally well enough for treatment, as assessed by my doctor?
- Do I have any other major lung conditions or allergies to the study drugs?
¿En qué consiste la participación?
If you join this study, you would receive either the new drug combination or standard chemotherapy. This would involve regular visits to the hospital for treatment, which is given through a drip (intravenous infusion). During these visits, you'll have blood tests, physical exams, and side effect checks. You would also have regular scans (like CT scans) to see how the cancer is responding to treatment. Researchers would also take blood samples to look for changes in your cancer over time. This study does not specify an exact duration, but participants are followed closely while receiving treatment and likely continue to be monitored afterwards. The total length of your participation would depend on how your cancer responds to treatment and overall health status.
Riesgos y beneficios potenciales
Locations (232)
- City of Hope 2Código postal verificadoDuarte, Estados Unidos
- Universidad de California en IrvineCódigo postal verificadoOrange, Estados Unidos
- UCLACódigo postal verificadoSanta Mónica, Estados Unidos
- Georgetown University HospitalCódigo postal verificadoWashington D.C., Estados Unidos
- H. Lee Moffitt Cancer & Research InstituteCódigo postal verificadoTampa, Estados Unidos
- University Cancer And Blood Center LLCCódigo postal verificadoAthens, United States
- Henry Ford HospitalCódigo postal verificadoDetroit, Estados Unidos
- Washington University Medical CenterCódigo postal verificadoSan Luis, Estados Unidos
- Regional Cancer Care Associates LLCCódigo postal verificadoEast Brunswick, United States
- Langone Health at NYC University, NYU School of MedicineCódigo postal verificadoNueva York, Estados Unidos
- Columbia University Medical CenterCódigo postal verificadoNueva York, Estados Unidos
- Providence Portland Medical CenterCódigo postal verificadoPortland, Estados Unidos
Preguntas comunes
What is an 'EGFR Exon 20 insertion'?
It's a specific genetic change, or 'mutation', found in some lung cancers. It helps doctors choose the best treatment.
What is amivantamab?
Amivantamab is a newer type of drug designed to target specific features of cancer cells, which researchers hope will help treat this particular type of lung cancer.
¿Definitivamente recibiré el nuevo medicamento?
No, this is a comparison study. You will either receive the new drug with chemotherapy or chemotherapy alone. It's decided randomly, like flipping a coin.
What are the main side effects of chemotherapy?
Common side effects can include feeling tired, sickness, hair loss, and a higher risk of infection. Your doctor will discuss all potential side effects with you.
How long will I be on the study?
The length of time you're on the study can vary. You'll receive treatment as long as it's helping and you're not having severe side effects. You'll also have follow-up appointments.
Cómo obtener más información
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
Discusión
Discusión comunitaria
Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.