Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)

This research is a trial for people with advanced non-small cell lung cancer that hasn't been treated yet. The main goal is to find out if combining a known immunotherapy drug called Cemiplimab with one of three new drugs (S095018, S095024, or S095029) is safe and effective. Immunotherapy works by helping your body's own immune system fight cancer. The study has two main parts: first, finding the safest dose for these new combinations, and then, looking at how well they work. Patients will receive treatment for up to 108 weeks, or until their cancer grows, or if they need to stop treatment for other reasons.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Servier Bio-Innovation LLC

Enrolment target

102

Start

07 Aug 2024

Estimated completion

01 Jul 2027

Non-small Cell Lung Cancer (NSCLC)

What is this study about?

This study is about finding better ways to treat a type of lung cancer called non-small cell lung cancer (NSCLC) when it is advanced and has spread. Doctors are always looking for new and more effective treatments. This particular study focuses on combining different types of immunotherapy. Immunotherapy is a treatment that helps your body's natural defense system – your immune system – find and destroy cancer cells.

The study uses an existing immunotherapy drug called Cemiplimab, which works by blocking a protein called PD-1 on immune cells, essentially taking the brakes off the immune system so it can attack cancer. This is being tested alongside three new experimental drugs (S095018, S095024, or S095029), each of which targets a different pathway that cancer uses to hide from the immune system. The hope is that by combining these drugs, the treatment will be more powerful against the cancer.

The research is split into two stages. The first stage is about safety: finding the right dose for each new combination to make sure it's as safe as possible. Once the best doses are found, the second stage will compare how well these combinations work in shrinking the cancer or stopping it from growing. This step-by-step approach helps researchers carefully test new treatments.

Key takeaways

This study evaluates new immunotherapy combinations for advanced, untreated non-small cell lung cancer.
It combines an existing drug, Cemiplimab, with one of three new experimental drugs.
The study aims to find safe doses and determine how effective these combinations are.
Treatment can last up to 108 weeks, with regular monitoring.
It's for adults with specific types of lung cancer and criteria regarding PD-L1 expression.
Participation involves regular hospital visits for treatment and assessments.

Who may be eligible?

To be able to join this study, you need to be an adult at least 18 years old and have advanced non-small cell lung cancer that doctors can’t remove with surgery or treat with full-dose radiation and chemotherapy. It's important that you haven't had any previous treatments for your advanced lung cancer. Your cancer should also show high levels of a specific protein called PD-L1, which helps doctors understand if immunotherapy might work for you. You also need to be generally well enough to take part, with a good level of physical activity.

There are also some reasons why you might not be able to join the study. For example, if your cancer has certain gene changes (like EGFR, ALK, or ROS1) for which there are already specific treatments, this study wouldn't be suitable. You also can't have had immunotherapy before, or have active cancer in your brain that isn't under control. Other conditions such as uncontrolled hepatitis B or C, HIV, certain autoimmune diseases, serious lung conditions, or if you are pregnant or breastfeeding, would also mean you couldn't 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 an adult aged 18 or older?
Do you have advanced non-small cell lung cancer that has not been treated before?
Does your cancer show high levels of PD-L1?
Do you not have specific genetic changes in your cancer (like EGFR, ALK, ROS1) that have their own treatments?
Have you never had immunotherapy before?
Are you not currently pregnant or breastfeeding, and do not have uncontrolled infections or serious autoimmune diseases?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive combination treatment for up to about two years (108 weeks), unless your cancer gets worse or you need to stop for other medical reasons. You will have regular visits to the hospital for your treatments, which will be given as infusions (through a drip into a vein). During these visits, the study team will monitor your health closely, including taking blood tests, checking your vital signs, and performing scans (like CT scans) to see how the treatment is affecting your cancer. They will also ask you about any side effects you might be experiencing. The study team will explain exactly how often you'll need to visit and what each visit will involve.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as gaining access to new treatments before they are widely available. However, there is no guarantee that the treatment will work for you, and it might not be better than standard treatments. There are also potential risks, including side effects from the study drugs. These side effects can range from mild to serious, and the study team will explain all known and potential risks to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care, and your doctors will continue to support you.

Locations (63)

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

Loma Linda University
Verified postcode
Loma Linda, United States
Henry Ford Health
Verified postcode
Detroit, United States
Comprehensive Cancer Center of Nevada
Verified postcode
Las Vegas, United States
Gabrail Cancer Center
Verified postcode
Canton, United States
Ohio State University Comprehensive Cancer Center
Verified postcode
Columbus, United States
Virginia Cancer Specialists, P.C.
Verified postcode
Fairfax, United States
Instituto Médico Especializado Alexander Fleming
Verified postcode
Buenos Aires, Argentina
Sanatorio Parque S.A.
Verified postcode
Santa Fe, Argentina
Border Medical Oncology Research Unit
Verified postcode
Albury, Australia
Flinders Medical Centre
Verified postcode
Bedford Park, Australia
Sunshine Hospital
Verified postcode
St Albans, Australia
Latrobe Regional Health
Verified postcode
Traralgon, Australia

Common questions

What is Non-small Cell Lung Cancer (NSCLC)?

NSCLC is the most common type of lung cancer. This study is for people whose NSCLC is advanced and hasn't been treated yet.

What is immunotherapy?

Immunotherapy is a treatment that helps your body’s own immune system fight cancer cells. It’s like giving your immune system a boost or removing its 'brakes'.

What are 'Phase 1b' and 'Phase 2' in a study?

Phase 1b studies are mainly about finding a safe dose for a new treatment. Phase 2 studies then look at how well the treatment works at that safe dose.

How long will I be on the treatment?

You will receive treatment for up to 108 weeks (about two years), unless your cancer grows or you need to stop for other medical reasons.

What is PD-L1 expression?

PD-L1 is a protein found on cancer cells. Its presence can help doctors decide if certain immunotherapy treatments might work for your specific cancer.