RecruitingPHASE3INTERVENTIONAL

A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1%

This research is a 'Phase 3' study, which means it's comparing treatments that are already showing promise. It focuses on people with advanced non-small cell lung cancer, specifically the non-squamous type, where the cancer has spread or come back. Doctors will be comparing two approaches: one uses the medicines Nivolumab and Relatlimab alongside chemotherapy, and the other uses Pembrolizumab with chemotherapy. The study is particularly for patients whose cancer cells show a certain level of a marker called PD-L1. The main aim is to see which of these treatment combinations works better at fighting the cancer, helping patients live longer, and improving their quality of life. Participants will be monitored closely to understand the effects of these treatments.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

1,000

Start

07 Oct 2024

Estimated completion

04 Aug 2032

Non-small Cell Lung Cancer

What is this study about?

This study is looking into new treatment options for a type of lung cancer called non-small cell lung cancer, specifically the non-squamous kind. This is the most common type of lung cancer. The study is for people whose cancer is advanced, meaning it has spread to other parts of the body (Stage IV), or it has come back after previous treatment.

The main idea is to compare two different ways of treating this cancer. One treatment involves a combination of two drugs, Nivolumab and Relatlimab, given together with chemotherapy. The other treatment uses a different drug called Pembrolizumab, also given with chemotherapy. Chemotherapy is a standard way to treat cancer, and these newer drugs (like Nivolumab, Relatlimab, and Pembrolizumab) are designed to help your body's immune system fight the cancer more effectively.

Researchers want to find out which of these combinations is more effective at shrinking the cancer, stopping it from growing, and ultimately helping people live longer and feel better. They will be carefully watching how well each treatment works and any side effects people might have. This is a "Phase 3" study, which means it's a large study comparing new treatments against current best practices to see if they offer a better option for patients.

Key takeaways

New study for advanced non-small cell lung cancer (non-squamous type).
Compares two immunotherapy and chemotherapy combinations.
Aims to find out which treatment works best for patients.
Participation involves regular clinic visits and monitoring.
Strict rules about who can join based on health and cancer type.

Who may be eligible?

To join this study, you would need to have been diagnosed with advanced non-small cell lung cancer (non-squamous type) that has either spread or come back. You shouldn't have had any chemotherapy for this advanced stage yet. Doctors will also check your cancer cells for something called PD-L1, and you'd need to have a certain amount of it.

You'd also need to be generally well enough to take part, meaning you can carry out most daily activities, and doctors can clearly measure your cancer on scans like CT or MRI. Your overall health and expected lifespan will also be considered.

There are also some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if your cancer has certain specific genetic changes that doctors already know how to treat with other targeted medicines. You also can't have certain other health conditions like active autoimmune diseases, specific brain metastases that haven't been treated, or a history of serious lung inflammation.

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 advanced non-small cell lung cancer (non-squamous type)?
Have I had any chemotherapy for this advanced cancer yet? (If yes, you might not be eligible).
Am I generally well enough to do most daily activities?
Do I have serious autoimmune conditions, untreated brain cancer, or certain specific genetic changes in my cancer?
Am I pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive one of the treatment combinations (either Nivolumab and Relatlimab plus chemotherapy, or Pembrolizumab plus chemotherapy). You would have regular visits to the clinic for your treatment and check-ups. These visits would involve blood tests, physical exams, and imaging scans (like CT or MRI) to monitor how well the treatment is working and to check for any side effects. You would continue treatment for as long as it is helping and you are tolerating it well. After the main treatment phase, there will be a follow-up period where your health will continue to be monitored. The total duration of your participation could vary, but it will involve ongoing check-ups for some time to understand the long-term effects of the treatment.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as gaining access to new treatments before they are widely available, which could be more effective than standard care. You would also receive very close medical attention and monitoring. However, there are always potential risks, as the treatments being tested may have side effects, some of which could be severe or unexpected. Not everyone will experience a benefit from the study treatment. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (312)

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

Local Institution - 0487
Verified postcode
Mobile, United States· Not yet recruiting
Southern Arizona VA Health Care System
Verified postcode
Tucson, United States· Recruiting
Local Institution - 0112
Verified postcode
Los Angeles, United States· Withdrawn
University of California Davis (UC Davis) Comprehensive Cancer Center
Verified postcode
Sacramento, United States· Recruiting
San Francisco Oncology Associates
Verified postcode
San Francisco, United States· Recruiting
UCLA Hematology/Oncology - Santa Monica
Verified postcode
Santa Monica, United States· Recruiting
Local Institution - 0500
Verified postcode
Grand Junction, United States· Not yet recruiting
Local Institution - 0472
Verified postcode
Westminster, United States· Not yet recruiting
University of Miami Hospital and Clinics, Sylvester Cancer Center
Verified postcode
Miami, United States· Recruiting
Memorial Hospital West
Verified postcode
Pembroke Pines, United States· Recruiting
Florida Cancer Specialists - North
Verified postcode
St. Petersburg, United States· Recruiting
Local Institution - 0477
Verified postcode
Tamarac, United States· Not yet recruiting

Common questions

What is non-small cell lung cancer?

It's the most common type of lung cancer. This study focuses on a specific kind within this group called 'non-squamous'.

What does 'Stage IV or recurrent' mean?

Stage IV means the cancer has spread beyond your lungs to other parts of your body. Recurrent means the cancer has come back after previous treatment.

What is PD-L1?

PD-L1 is a protein found on cancer cells that can help them hide from your body's immune system. Treatments in this study often target this protein to help your immune system fight the cancer.

What are Nivolumab, Relatlimab, and Pembrolizumab?

These are types of immunotherapy drugs that work by boosting your own immune system to help it recognise and attack cancer cells.

Will I know which treatment I'm getting?

In this type of study, participants are usually randomly assigned to one of the treatment groups, and sometimes neither you nor your doctor will know which one you are receiving until the study is over. This helps ensure fair results.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Clinical.Trials@bms.com 855-907-3286 Official trial record

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