Active not recruitingPHASE3INTERVENTIONAL

A Study to Compare ABP 234 and Keytruda® (Pembrolizumab) in Participants With Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer

This study is looking at an investigational new medicine called ABP 234 and comparing it to Keytruda (pembrolizumab), a common treatment for advanced lung cancer. Specifically, it's for people with a non-squamous non-small cell lung cancer that has either spread or is advanced. The main goal is to find out if ABP 234 acts in the body in a very similar way to Keytruda. This is a Phase 3 study, meaning it's one of the final steps before a new medicine might be approved for wider use. Researchers want to ensure ABP 234 is as effective and safe as the established treatment. It's an important step in potentially expanding treatment options for this type of cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Amgen

Enrolment target

315

Start

09 Sep 2024

Estimated completion

24 Apr 2028

Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer

What is this study about?

This study is comparing two medicines for a type of lung cancer called non-small cell lung cancer, specifically the non-squamous kind, which has spread or is advanced. One medicine is Keytruda (pembrolizumab), which is already an approved and widely used treatment. The other is ABP 234, which is a new medicine that researchers hope will work similarly to Keytruda.

The main purpose of this study is to see if ABP 234 behaves in the same way in the body as Keytruda. This is really important because if a new medicine can be shown to be very similar to an existing, effective treatment, it could offer another option for patients in the future. Having more treatment choices can be beneficial for many reasons, including potentially making treatments more accessible or offering alternatives if one doesn't suit a patient.

This is a Phase 3 study, which means it’s one of the last stages of testing for new medicines. At this stage, doctors and scientists are looking for clear evidence that the new medicine is not only safe but also works just as well as, or very similarly to, existing treatments. Your participation would help gather crucial information that could lead to new treatment options becoming available for people living with this type of lung cancer.

Key takeaways

Compares a new medicine (ABP 234) with an existing one (Keytruda) for advanced lung cancer.
Specifically for non-squamous non-small cell lung cancer that has spread.
Aims to see if the new medicine works similarly to the established treatment.
Phase 3 trial – a key step before potential wider availability.
Involves regular hospital visits for treatment and monitoring.
Participation could lead to more treatment options for this type of cancer.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a specific type of lung cancer called stage IV non-squamous non-small cell lung cancer. This means your cancer has spread, and it's not the 'squamous' or 'small cell' type. You also can't have had any medication for your advanced lung cancer before starting the study.

Doctors will also check your overall health and how well your body is working, often using a standard score to make sure you're well enough. Your cancer needs to be measurable, meaning doctors can see and track it, and they will need some tissue from your tumour for close examination. It's important that your cancer tests negative for certain gene changes (EGFR, ALK, and ROS-1). You should also expect to live for at least three more months.

There are also some reasons why you might not be able to join. For example, if you have other types of lung cancer like small cell or squamous, or if your cancer has spread to your brain and hasn't been treated yet. You also can't have certain immune system problems or be allergic to the study medicines or similar drugs. If you've already had chemotherapy, immunotherapy, or other specific cancer treatments for your advanced cancer, 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.

Are you at least 18 years old?
Do you have stage IV non-squamous non-small cell lung cancer that hasn't been treated yet for advanced disease?
Do doctors have a tissue sample from your tumour to examine?
Are your cancer tests negative for EGFR, ALK, and ROS-1 gene changes?
Have you NOT had previous chemotherapy, immunotherapy, or other specific cancer drugs for your advanced cancer?
Do you NOT have active brain metastases that haven't been treated?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new medicine (ABP 234) or the existing medicine (Keytruda/pembrolizumab). Both of these would be given through a drip into your vein. You would have regular appointments at the hospital for these treatments and for check-ups.

These check-ups would involve doctors examining you, taking blood and urine samples, and performing scans (like CT scans) to see how your cancer is responding. There would also be questionnaires to assess how you're feeling and how the treatment is affecting your daily life. The exact number and frequency of visits would be explained in detail by the study team, but typically, these studies involve regular trips to the clinic for a period of time, followed by less frequent follow-up checks. The total duration of your participation would depend on how well you respond to the treatment and for how long you can safely continue receiving it.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as access to a new investigational medicine (ABP 234) or an established treatment (Keytruda), and close monitoring by a specialist medical team. Your involvement could also contribute to scientific knowledge that helps other patients in the future. However, there are potential risks, including side effects from the treatments that can be mild or more serious, and the possibility that the treatment may not work for you. You will be fully informed about all known risks before joining, and you always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (218)

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

Precision NextGen Oncology and Research Center
Verified postcode
Beverly Hills, United States
TOI Clinical Research
Verified postcode
Cerritos, United States
Cancer and Blood Specialty Clinic (CBSC)
Verified postcode
Los Alamitos, United States
Valkyrie Clinical Trials
Verified postcode
Los Angeles, United States
PIH Health Hospital
Verified postcode
Whittier, United States
Millennium Oncology - Hollywood
Verified postcode
Hollywood, United States
BRCR Medical Center Inc.
Verified postcode
Tamarac, United States
Accellacare Duly
Verified postcode
Plainfield, United States
Accellacare of McFarland
Verified postcode
Ames, United States
Detroit Clinical Research Center, PC
Verified postcode
Farmington Hills, United States
North Shore Hematology-Oncology Associates P.C. d/b/a New York Cancer & Blood Specialists
Verified postcode
Shirley, United States
Gabrail Cancer Center Research
Verified postcode
Canton, United States

Common questions

What kind of lung cancer is this study for?

This study is for advanced or metastatic non-squamous non-small cell lung cancer.

What are the medicines being tested?

The study compares a new medicine called ABP 234 with an existing treatment called Keytruda (pembrolizumab).

Why is this study being done?

The main goal is to see if ABP 234 works in the body similarly to Keytruda, potentially offering another treatment option in the future.

Will I know which medicine I'm getting?

In this type of study, you might not know if you're getting the new medicine or the existing one, but the study team will explain the details.

How long will I be in the study?

The duration varies. You'll have regular treatments and check-ups, and the study team will discuss the expected length of your participation based on your response and safety.