RecruitingPHASE2INTERVENTIONAL

Preoperative Amivantamab or Amivantamab and Carboplatin/Pemetrexed Treatment in Patients With Resectable Non-small-cell Lung Cancer Harboring Oncogenic EGFR Mutations (NEOpredict-EGFR)

This study, called NEOpredict-EGFR, is investigating a new way to treat non-small cell lung cancer (NSCLC) that has specific genetic changes (called EGFR mutations). For patients who can have surgery, researchers want to see if giving a drug called amivantamab before the operation is a good idea. Some patients will receive amivantamab on its own, and others will get it combined with standard chemotherapy drugs (carboplatin and pemetrexed). After this pre-surgery treatment, patients will have their usual surgery. If needed, they might also receive standard follow-up treatments like chemotherapy or radiotherapy. The main goal is to find out if giving amivantamab before surgery is practical and beneficial for these patients.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University Hospital, Essen

Enrolment target

Start

06 Nov 2024

Estimated completion

31 Dec 2027

Lung Cancer (NSCLC)

What is this study about?

This study is looking into a new treatment approach for specific types of lung cancer. Doctors are trying to find the best ways to treat non-small cell lung cancer (NSCLC), especially when it has certain genetic changes, known as EGFR mutations. These mutations can make cancer grow and respond differently to treatments.

Traditionally, surgery is a main treatment for early-stage lung cancer. This study explores whether giving a special drug called amivantamab, sometimes combined with other chemotherapy drugs, *before* surgery can improve outcomes. Amivantamab is a targeted therapy designed to block signals that help cancer cells grow, specifically in cancers with these EGFR mutations. The idea is that treating the cancer before surgery might shrink it or make the surgery more effective.

The study is divided into two stages. In the first stage, patients will receive amivantamab on its own. In the second stage, some patients will receive amivantamab along with a standard chemotherapy combination (carboplatin and pemetrexed). After this pre-surgery treatment, all patients will have their scheduled surgery. If their doctors think it's necessary, they will also receive regular follow-up treatments like chemotherapy or radiotherapy. The researchers want to understand if this pre-surgery treatment is safe, practical, and potentially helpful for patients, ultimately aiming to improve how lung cancer is treated.

Key takeaways

This study explores a new pre-surgery treatment for lung cancer.
It focuses on non-small cell lung cancer with specific EGFR gene changes.
Patients receive amivantamab (with or without chemotherapy) before their planned surgery.
The main goal is to see if this approach is practical and helpful.
You will receive standard surgery and follow-up care as needed.

Who may be eligible?

To join this study, you would need to have been diagnosed with non-small cell lung cancer (NSCLC) that your doctors believe can be completely removed by surgery. This includes certain stages of the disease, from early to some more advanced cases, as decided by your care team.

tint Importantly, your cancer must have specific genetic changes called EGFR mutations. These mutations will be identified through tests on a sample of your cancer tissue. You must also be 18 years old or older to take part.

If you are a woman who could become pregnant, you'll need to have a negative pregnancy test before starting treatment and agree to use effective birth control during the study and for six months afterwards. Men in the study also need to use effective birth control if their partner could become pregnant.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have I been diagnosed with non-small cell lung cancer?
Do my doctors believe my cancer can be completely removed by surgery?
Has my cancer been tested and confirmed to have specific EGFR gene changes?
Am I 18 years old or older?
If I am a woman who could become pregnant, am I able to use effective birth control?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first receive the study treatment for four weeks. This means you would either get amivantamab by itself or amivantamab combined with chemotherapy drugs. These treatments are given as an infusion into your vein, usually at a clinic or hospital. During this period, you would have regular visits for check-ups and tests to see how you are responding and to monitor for any side effects.

After these four weeks, you would have your planned surgery to remove the lung cancer. Following surgery, your doctors will decide if you need any additional, standard treatments, such as more chemotherapy or radiotherapy, which would be part of your usual care. You would then have regular follow-up appointments to monitor your recovery and health for an extended period, though the exact total duration of follow-up is not specified here. The study aims to look at your health over time.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing new and promising treatments before they are widely available. For this study, the hope is that pre-surgery treatment with amivantamab might improve the success of your surgery or your overall outcome. However, there are also potential risks involved; new treatments can have side effects that are not yet fully known or experienced by everyone. The research team will carefully monitor you for any side effects, and they will fully explain all known risks before you make a decision. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your future medical care.

Locations (4)

Jessa Ziekenhuis, Department of Pneumology
Verified postcode
Hasselt, Belgium· Recruiting
Thoraxklinik Heidelberg gGmbH, Studienzentrum Thoraxonkologie
Verified postcode
Heidelberg, Germany· Recruiting
West German Cancer Center, Department of Medical Oncology, University Hospital Essen
Verified postcode
Essen, Germany· Recruiting
Erasmus Universitair Medisch Centrum Rotterdam Department of Pulmonary Medicine
Verified postcode
Rotterdam, Netherlands· Recruiting

Common questions

What is amivantamab?

Amivantamab is a targeted drug designed to specifically block signals that help certain non-small cell lung cancer cells grow, particularly those with EGFR gene changes.

Why is this treatment given before surgery?

The study aims to see if giving this treatment before surgery can shrink the cancer or make the surgery more effective, potentially leading to better outcomes.

What are EGFR mutations?

EGFR mutations are specific changes in the genes of some lung cancer cells. They can make the cancer grow and may mean it responds better to certain targeted treatments like amivantamab.

Will I still have surgery if I join this study?

Yes, all patients in this study are expected to have surgery after completing the initial treatment phase with amivantamab (and chemotherapy, if applicable).

Is this a new type of treatment?

Amivantamab is a newer type of targeted therapy for lung cancer. This study is testing a new way of using it – before surgery – to see how effective it is in this setting.

How to find out more

Martin Schuler, Prof. Dr. med.

neopredictegfr.umesz@uk-essen.de +492017232011 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.