Active not recruitingPHASE2INTERVENTIONAL

A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer

This study is testing different combinations of new immunotherapy drugs for people with advanced non-small cell lung cancer that hasn't received treatment yet. Immunotherapy helps your body's own immune system fight cancer. We're particularly looking for people whose lung cancer cells show high levels of a protein marker called PD-L1. The main goal is to check how safe these new drug combinations are. We're hoping to find better ways to treat this type of lung cancer by exploring these new approaches, potentially leading to more effective options in the future. The study involves several different drugs, including Pembrolizumab, Dostarlimab, Belrestotug, and Nelistotug, used in various combinations.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

GlaxoSmithKline

Enrolment target

351

Start

14 Oct 2022

Estimated completion

26 Feb 2027

Lung Cancer, Non-Small Cell

What is this study about?

This study is exploring new treatment options for people diagnosed with advanced non-small cell lung cancer. This is a type of lung cancer that has either spread to other parts of the body (metastatic) or is locally advanced, meaning it has grown significantly in the area where it started and can't be removed with surgery or treated with strong radiotherapy. The cancer also shouldn't have been treated with any other medicines for this advanced stage before.

The main focus of this research is a type of medicine called immunotherapy. Immunotherapy works by boosting your body's natural defense system, your immune system, to recognize and fight cancer cells. The study is particularly interested in people whose cancer cells have a high level of a specific marker called PD-L1. This marker can help doctors predict whether immunotherapy might be a good option for a patient. We're testing different combinations of new immunotherapy drugs to see how safe they are when given together.

The idea behind combining these new drugs is that they might work better as a team than they would alone, potentially offering a more powerful way to fight the cancer. The study will carefully monitor participants to understand any side effects and see how their bodies respond to these new treatment combinations. This kind of research is vital for finding new and improved ways to help people with non-small cell lung cancer.

Key takeaways

This study is for advanced non-small cell lung cancer that hasn't been treated yet.
It's testing new combinations of immunotherapy drugs to check their safety.
Your cancer needs to show high levels of a marker called PD-L1.
You will have regular check-ups, scans, and blood tests.
You can leave the study at any time.
It's important to discuss the potential benefits and risks with your doctor.

Who may be eligible?

This study is looking for people aged 18 or over who have non-small cell lung cancer that is advanced (meaning it's spread or can't be removed by surgery/radiotherapy) and hasn't been treated with other medicines for this stage before. Your cancer cells must also show a high level of a marker called PD-L1, and doctors need to be able to measure your cancer on scans. You should also generally be in good health and able to carry out your daily activities with little difficulty.

There are some reasons why you might not be able to join. For example, if your cancer has certain genetic changes that can be treated with specific targeted drugs, or if you've had major surgery or strong lung radiotherapy recently. You also can't have received certain types of immunotherapy before. People who have never smoked, or who have other significant medical conditions like active autoimmune diseases or untreated brain metastases, might not be suitable. We also can't include people who are taking certain steroid medications or have had a live vaccine recently. All women who could become pregnant would need to use effective contraception.

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 non-small cell lung cancer that hasn't been treated before?
Has my doctor confirmed my cancer has high levels of the PD-L1 marker?
Am I generally well enough to go about my daily activities?
Have I had any major surgery or strong lung radiotherapy recently?
Do I have any serious untreated conditions, like active autoimmune diseases or untreated brain problems?
Am I currently taking any regular steroid medicines or similar immunosuppressants?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive a combination of new immunotherapy drugs. You will have regular visits to the clinic for medical checks, scans, and blood tests to monitor your health and how you respond to the treatment. These visits will help the study team keep track of any side effects and see if the treatment is working. The specific schedule of visits and tests will be explained in detail by the study team, but generally, there will be frequent visits during the initial treatment period, then less often. You will continue to be monitored even after the main treatment phase ends. The total duration of your involvement could vary, but follow-up will be ongoing. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving new treatments before they are widely available, which could help manage your cancer. However, there's no guarantee the treatment will work for you. As with all medicines, there are potential risks and side effects, some of which may be serious or unexpected. The study team will explain all known side effects and monitor you very closely. You have the right to withdraw from the study at any time, for any reason, without impacting your current or future medical care.

Locations (99)

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

GSK Investigational Site
Verified postcode
Plantation, United States
GSK Investigational Site
Verified postcode
Albuquerque, United States
GSK Investigational Site
Verified postcode
Chattanooga, United States
GSK Investigational Site
Verified postcode
Morgantown, United States
GSK Investigational Site
Verified postcode
Buenos Aires, Argentina
GSK Investigational Site
Unverified
Cipoletti Rio Negro, Argentina
GSK Investigational Site
Unverified
Ciudad Autonoma de Buenos Aire, Argentina
GSK Investigational Site
Unverified
Ciudad Autonoma de Buenos Aire, Argentina
GSK Investigational Site
Verified postcode
Florida, Argentina
GSK Investigational Site
Verified postcode
Mar del Plata, Argentina
GSK Investigational Site
Verified postcode
San Juan, Argentina
GSK Investigational Site
Verified postcode
Santa Fe, Argentina

Common questions

What is 'advanced non-small cell lung cancer'?

This means your lung cancer has either spread to other body parts or has grown significantly in its original location, and it can't be cured with surgery or strong radiotherapy.

What is PD-L1?

PD-L1 is a protein found on cancer cells that can help them 'hide' from the body's immune system. High levels of PD-L1 often mean immunotherapy drugs might be more effective.

What is immunotherapy?

Immunotherapy is a type of cancer treatment that helps your own immune system fight cancer cells more effectively.

Will I get paid to be in the study?

Clinical trials generally do not pay participants for their time, but any travel costs for study visits might be covered. You should ask the study team about this.

Can I continue with my usual medications?

The study team will review all your current medications. Some medications, like certain steroids or immunosuppressants, might prevent you from joining or need to be stopped during the study.