Active not recruitingPHASE3INTERVENTIONAL

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

This study is for people in the UK with a type of lung cancer called non-small cell lung cancer that has spread or is advanced. Specifically, it's for those whose cancer has a particular genetic fault (called an EGFR mutation, either Exon 19del or Exon 21 L858R). The study aims to see if a new combination of two drugs, amivantamab and lazertinib, works better and is safer than a commonly used drug called osimertinib. It's an important step in finding new and better treatments for this specific type of lung cancer. This is a Phase 3 study, meaning these treatments have already been tested in smaller groups and are now being compared to standard care.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

1,074

Start

30 Sep 2020

Estimated completion

30 Nov 2027

Carcinoma, Non-Small-Cell Lung

Results

Results from this study

Posted October 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) the absence of progression, whichever came first. Disease progression was defined using RECIST 1.1 as a 20 percent (%) increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 millimeters (mL). 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.

Full results on the registry

What is this study about?

This clinical trial is designed for people in the UK who have a type of lung cancer called non-small cell lung cancer. This particular study is focusing on cancer that has either spread to other parts of the body (metastatic) or is advanced (locally advanced), and importantly, has a specific genetic change. This change is in a gene called EGFR, and the study is looking for two particular types of EGFR changes: one called Exon 19 deletions (Exon 19del) or another called Exon 21 L858R substitution. These specific genetic changes mean that certain treatments might work better for these cancers.

The main goal of this study is to compare two different ways of treating this lung cancer. One way uses a combination of two drugs, amivantamab and lazertinib. The other way uses a single drug, osimertinib, which is already a known treatment. Researchers want to find out if the combination therapy is more effective at treating the cancer and if it has a manageable side effect profile compared to osimertinib.

This kind of research is really important because it helps doctors find better ways to treat cancer. By comparing new treatments with existing ones, we can learn which options offer the best chance for patients. The aim is always to improve how well patients respond to treatment and, ultimately, to improve their quality of life. This particular study is in Phase 3, which means the drugs have already been tested in smaller groups of people and are now being compared more widely to the current standard care.

Key takeaways

This study is for advanced non-small cell lung cancer with specific EGFR genetic changes.
It compares a new two-drug combination against a standard single drug.
The goal is to find better treatments for this particular lung cancer.
Participation involves regular hospital visits, tests, and medication.
This is a Phase 3 trial, a key step in drug development.

Who may be eligible?

To join this study, you need to have non-small cell lung cancer that has been recently diagnosed as advanced or spread, and importantly, hasn't been treated with any other cancer medicines for this advanced stage. Your cancer also needs to have a specific genetic change in a gene called EGFR (either Exon 19del or Exon 21 L858R). This will be checked using a sample of your tumour.

There are also some requirements about your general health. Any side effects you might have from earlier cancer treatments (like for an earlier stage of cancer) must have mostly cleared up. You'll also need to have at least one measurable tumour spot that hasn't been treated with radiation before, so doctors can track how well the treatment is working.

Some reasons why you might not be able to join include if you've already had medicine for your advanced or widespread lung cancer. Also, if you have certain conditions like cancer cells spreading to the fluid around your brain and spinal cord (leptomeningeal disease) or an untreated spinal cord problem, you won't be able to 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.

I have non-small cell lung cancer that is advanced or has spread.
My cancer has a specific genetic change (EGFR Exon 19del or Exon 21 L858R).
I haven't had any prior treatment for this advanced stage of lung cancer.
Any side effects from previous cancer treatments have mostly gone away.
I'm at least 18 years old.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will likely have regular hospital visits for check-ups, tests, and to receive your study medication. The study will involve giving blood samples and sometimes a fresh tissue sample from your tumour. Doctors will regularly check your cancer to see how it's responding to the treatment using scans, such as CT or MRI scans. You will be taking one of the study medications, either the combination of amivantamab and lazertinib or osimertinib, which will be given to you by the study team. They will also keep a close eye on any side effects you might experience. The total duration of your participation in the study is not specified but usually continues as long as the treatment is helping and acceptable, followed by a period of follow-up after the treatment stops.

Potential risks and benefits

Taking part in this study could offer you access to new treatments that are not yet widely available, and it might help us find better ways to treat your type of lung cancer. However, like all medicines, the study drugs can have side effects, which could range from mild to serious. The research team will explain all the known and potential risks to you in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care, and the study team will always put your well-being first.

Locations (269)

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

Arizona Oncology Associates, PC - HAL
Verified postcode
Goodyear, United States
Yuma Regional Medical Center
Verified postcode
Yuma, United States
City of Hope Long Beach Elm
Verified postcode
Long Beach, United States
University of California Irvine
Verified postcode
Orange, United States
Rocky Mountain Cancer Centers
Verified postcode
Lone Tree, United States
Cancer Specialists of North Florida
Verified postcode
Jacksonville, United States
University Cancer And Blood Center LLC
Verified postcode
Athens, United States
East Jefferson General Hospital
Verified postcode
Metairie, United States
Maryland Oncology Hematology, PA
Verified postcode
Columbia, United States
Henry Ford Hospital
Verified postcode
Detroit, United States
Minnesota Oncology Hematology P A
Verified postcode
Edina, United States
Mayo Clinic
Verified postcode
Rochester, United States

Common questions

What is EGFR mutation?

EGFR stands for Epidermal Growth Factor Receptor. It's like a switch on cancer cells. When it has certain changes (mutations), it can make the cancer grow. Some medicines work by blocking this switch.

What does 'locally advanced or metastatic' mean?

Locally advanced means the cancer has grown outside the lung but hasn't spread to distant parts of the body. Metastatic means the cancer has spread to other parts of the body, like bones or the liver.

What is a Phase 3 study?

A Phase 3 study is a large study that compares a new treatment with the best available standard treatment. It's one of the last steps before a treatment might be approved for general use.

Will I know which treatment I am getting?

Often in studies like this, participants are randomly assigned to a treatment group, and sometimes neither you nor your doctor will know which treatment you are receiving (this is called 'blinded'). This helps make sure the results are fair.

What if I get side effects?

The study team will closely monitor you for any side effects. You should report any new or worsening symptoms immediately. They will provide care and guidance to manage any side effects.