Active not recruitingPHASE3INTERVENTIONAL

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.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

308

Start

13 Oct 2020

Estimated completion

02 Aug 2027

Carcinoma, Non-Small-Cell Lung

Results

Results from this study

Posted May 2024

Results have been published for this study.

Primary outcome

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)

PFS was defined as the time from randomization until the date of objective disease progression based on BICR using RECIST version 1.1 or death (by any cause) in the absence of progression, whichever came first. Participants who have not progressed or have not died at the time of analysis were censored at the time of the latest date of their last evaluable RECIST version 1.1 assessment. Pharmacodynamic: Sum of diameters increased by greater than or equal to (\>=)20 percent (%) and \>=5 millimeter (mm) from nadir (including baseline if it was smallest sum).

Full results on the registry

What is this study about?

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.

Key takeaways

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.

Who may be eligible?

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.

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.

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?

Answer every question to see your result.

What does participation involve?

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.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. A potential benefit of this study is that the new combination treatment *might* be more effective at stopping your cancer from growing for longer compared to standard chemotherapy alone. However, there's no guarantee it will work for everyone, or that it will be better than the existing treatment. Potential risks include side effects from the medications, which can vary widely and will be discussed in detail by your study doctors. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (232)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

City of Hope 2
Verified postcode
Duarte, United States
University of California Irvine
Verified postcode
Orange, United States
UCLA
Verified postcode
Santa Monica, United States
Georgetown University Hospital
Verified postcode
Washington D.C., United States
H. Lee Moffitt Cancer & Research Institute
Verified postcode
Tampa, United States
University Cancer And Blood Center LLC
Verified postcode
Athens, United States
Henry Ford Hospital
Verified postcode
Detroit, United States
Washington University Medical Center
Verified postcode
St Louis, United States
Regional Cancer Care Associates LLC
Verified postcode
East Brunswick, United States
Langone Health at NYC University, NYU School of Medicine
Verified postcode
New York, United States
Columbia University Medical Center
Verified postcode
New York, United States
Providence Portland Medical Center
Verified postcode
Portland, United States

Common questions

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.

Will I definitely get the new drug?

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.