Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Randomized, Double-Blind, Phase II Study of BMS-986315 and Nivolumab in Combination with Chemotherapy Versus Nivolumab in Combination with Chemotherapy as First-line Treatment for Participants with Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

This research study is for people with advanced non-small cell lung cancer. Doctors are comparing two different treatment combinations. Both groups will get standard chemotherapy with nivolumab (Opdivo), but one group will also receive an investigational new drug called BMS-986315. Researchers want to understand if adding this new drug makes the treatment more effective and if it's safe. They’ll be looking at how well the tumours respond and what side effects people might experience. Finding more effective and safer treatments is really important for people living with this type of lung cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Bristol-Myers Squibb Services Unlimited Company

Enrolment target

Start

22 Jan 2024

Non-small Cell Lung Cancer

What is this study about?

This study is focused on a type of lung cancer called non-small cell lung cancer (NSCLC) that has either spread (Stage IV) or has come back after treatment. Currently, standard treatments often involve chemotherapy and drugs like nivolumab, which helps your body's immune system fight cancer.

Researchers are trying to find even better ways to treat this condition. In this study, some participants will receive the usual chemotherapy along with nivolumab. Another group will receive the same chemotherapy and nivolumab, but they will also get an additional new drug called BMS-986315. The main goal is to see if adding BMS-986315 improves how well the treatment works and to track any side effects people might have.

By comparing these two treatment approaches, doctors hope to learn if the new drug combination is more effective at shrinking tumours and controlling the cancer, and if it's a safe option. This kind of research is crucial for developing new medicines and improving care for future patients.

Key takeaways

Targets advanced non-small cell lung cancer.
Compares standard treatment plus a new drug vs. standard treatment only.
Studies how safe and effective the new combination is.
Aims to find better treatments for lung cancer.
Participation involves regular hospital visits for treatment and monitoring.

Who may be eligible?

To join this study, you must be at least 18 years old. Both men and women can take part. The study is specifically for people who have been diagnosed with non-small cell lung cancer that has either spread to other parts of the body (Stage IV) or has returned after previous treatment.

Your doctors will need to check your general health and specific details about your cancer to make sure this study is the right fit for you. There will be other health requirements and conditions that must be met to ensure your safety and that the study results are clear.

It’s important to discuss your full medical history with your doctor if you are interested in this study. They can confirm if you meet all the necessary criteria.

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 advanced non-small cell lung cancer (Stage IV or recurrent)?
Are you able to travel to a study site for regular appointments?
Are you generally well enough to undergo cancer treatment?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be assigned to one of two treatment groups. Both groups will receive chemotherapy along with nivolumab (Opdivo). If you are in the other group, you will also receive the extra study drug, BMS-986315. These treatments will be given as infusions (into a vein) over a period of time decided by the study.

You will have regular hospital visits for your treatments, blood tests, and scans to check how you’re responding to the treatment and to monitor for any side effects. You'll be closely monitored throughout the study, and your doctors will keep track of your health and progress. The total duration of your participation will depend on how you respond to the treatment and discussion with your study doctor.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as receiving a new investigational treatment that isn't yet widely available, or closer monitoring of your health. However, there are also potential risks, including side effects from the medications, which can vary from mild to serious, or the treatment might not work for you. Your well-being is always the priority, and you have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (5)

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

—
Unverified
Spain
—
Unverified
Romania
—
Unverified
Italy
—
Unverified
Poland
—
Unverified
France

Common questions

What is 'Non-Small Cell Lung Cancer'?

It's the most common type of lung cancer. This study is for advanced cases where the cancer has spread or come back.

What is Nivolumab (Opdivo)?

Nivolumab is a type of immunotherapy that helps your body's immune system recognise and fight cancer cells.

What does 'Phase II Study' mean?

It means this is an early-to-mid stage study. Researchers are looking closely at how safe the new treatment is and if it shows promise in treating the condition.

Will I know which treatment I'm getting?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know which specific treatment you are receiving. This helps make the study results more reliable.

Who pays for the treatment and hospital visits?

Typically, the study sponsor covers the cost of the study drugs and any tests or visits directly related to the research. You should discuss this with the study team.