Active not recruitingPHASE3INTERVENTIONAL

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

This study is for people with a type of lung cancer called non-small cell lung carcinoma, where the cancer has specific gene changes (EGFR mutation) and has grown or spread despite treatment with a drug called osimertinib. We are testing new combinations of drugs, including amivantamab and lazertinib, alongside standard chemotherapy (pemetrexed and carboplatin). The main goal is to see if these new combinations are more effective than standard chemotherapy alone in shrinking the cancer or slowing its growth. We also want to understand if these new combinations are safe to use. After the main part of the study, there might be an option for participants to continue receiving their assigned treatment for longer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

776

Start

17 Nov 2021

Estimated completion

30 Nov 2027

Carcinoma, Non-Small-Cell Lung

Results

Results from this study

Posted April 2025

Results have been published for this study.

Primary outcome

Main Study: 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 is defined as the time from randomization until the date of objective disease progression or death, whichever came first, as assessed by BICR according to RECIST version 1.1. Progressed disease: 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 research study is about finding better ways to treat a specific type of lung cancer known as non-small cell lung carcinoma. This particular cancer has a genetic change, or mutation, in a gene called EGFR (Epidermal Growth Factor Receptor). These EGFR mutations can sometimes make the cancer grow and spread more easily.

Patients taking part in this study have already been treated with a drug called osimertinib, but their cancer has unfortunately started to grow again or has spread. This study is testing whether adding new drugs, amivantamab and lazertinib, to standard chemotherapy (pemetrexed and carboplatin) can be more effective than chemotherapy on its own. The hope is that these new combinations might help control the cancer for longer or shrink it more effectively.

The study involves comparing different treatment groups to see which one works best and is safest. Looking at these new drug combinations helps doctors learn more about how to best treat this type of lung cancer when osimertinib is no longer working. It's an important step in trying to improve care for people with this condition.

Key takeaways

Tests new drug combinations for advanced lung cancer (EGFR-mutated NSCLC).
For patients whose cancer has worsened after osimertinib treatment.
Compares new drug combinations against standard chemotherapy.
Aims to find more effective and safer treatments.
You might receive new drugs or standard chemotherapy, decided by chance.
Participation is voluntary and you can withdraw at any time.

Who may be eligible?

This study is looking for adults aged 18 and over who have been diagnosed with advanced non-small cell lung cancer that has spread or is difficult to treat locally. Your cancer must have specific genetic changes called EGFR Exon 19del or Exon 21 L858R mutations. It's important that your cancer has previously been treated with the drug osimertinib, but has since started to get worse.

You should generally be well enough to take part in a study like this, meaning you can mostly look after yourself. If you have had cancer spread to your brain, it must have been treated and be stable. Also, any side effects from your previous treatments should have mostly cleared up to a mild level.

Women who could become pregnant will need to have negative pregnancy tests and agree to use effective contraception during the study. The study team will check all these details carefully to make sure it's safe for you to participate.

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.

Are you an adult aged 18 or older?
Do you have non-small cell lung cancer with specific EGFR gene changes?
Has your cancer started to grow or spread again after being treated with osimertinib?
Are you generally well enough to participate in a study?
If you had cancer spread to your brain, was it treated and is it now stable?
Are any side effects from your previous treatments mostly mild?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be randomly assigned to one of several treatment groups. This means neither you nor your doctor can choose which treatment you receive, it's decided by chance, like flipping a coin. You will receive either the new drug combinations with chemotherapy or just chemotherapy. You will have regular visits to the hospital for treatment, which will be given through a drip (intravenous infusion), and to have tests like blood samples and scans (such as CT or MRI scans) to see how you are responding to treatment.

The study will also involve regular check-ups to monitor any side effects and your general health. The length of time you participate will depend on how your cancer responds to the treatment and whether you experience any difficult side effects. After the main part of the study, there might be a chance to continue receiving your assigned treatment if it is helping you. The total duration of active treatment and follow-up will be explained by the study team.

Potential risks and benefits

Taking part in a clinical trial means you might get access to new treatments before they are widely available, which could potentially be more effective for your cancer. However, there's no guarantee that the new treatments will work better than standard care, and there's a possibility they might not help your cancer at all. Like all medicines, the treatments in this study can have side effects, which can range from mild to serious. The study team will monitor you closely for any side effects and will explain these to you in detail. It's very important to remember that participating in this study is completely voluntary. You can decide to withdraw from the study at any time, for any reason, without it affecting your usual medical care. Before deciding, make sure you understand all the benefits and risks, and feel comfortable with your decision.

Locations (249)

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

Southern Cancer Center, PC
Verified postcode
Mobile, United States
Arizona Oncology Associates
Verified postcode
Tucson, United States
City of Hope
Verified postcode
Duarte, United States
Cedars Sinai Medical Center
Verified postcode
Los Angeles, United States
University of California Irvine
Verified postcode
Orange, United States
Rocky Mountain Cancer Centers
Verified postcode
Colorado Springs, United States
Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center
Verified postcode
Fort Lauderdale, United States
University Cancer And Blood Center LLC
Verified postcode
Athens, United States
University of Mississippi Medical Center
Verified postcode
Jackson, United States
Nebraska Cancer Specialists
Verified postcode
Grand Island, United States
Astera Cancer Care
Verified postcode
East Brunswick, United States
TriHealth Network
Verified postcode
Cincinnati, United States

Common questions

What type of lung cancer is this study for?

This study is for a type of lung cancer called non-small cell lung carcinoma, specifically with certain changes (mutations) in the EGFR gene.

What does 'osimertinib failure' mean?

It means your lung cancer has started to grow or spread again, even though you have been treated with the medicine osimertinib.

What are the new drugs being tested?

The study is looking at drugs called amivantamab and lazertinib, in combination with standard chemotherapy.

Will I definitely get the new drugs?

No, participants are randomly assigned to different treatment groups, so you might receive the new drugs with chemotherapy, or just standard chemotherapy.

Can I leave the study at any time?

Yes, taking part is voluntary, and you can withdraw from the study at any point without it affecting your future medical care.