RecruitingPHASE3INTERVENTIONAL

A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).

This study aims to find out if a new combination medicine, BMS-986489 (which includes BMS-986012 and Nivolumab), works better and is safer than a commonly used treatment called Atezolizumab. Both treatments will be given alongside standard chemotherapy (Carboplatin and Etoposide). The study is for adults with extensive-stage small cell lung cancer who are about to start their very first treatment for this condition. By comparing these approaches, researchers hope to improve how this type of lung cancer is treated, potentially offering a new, more effective option for patients.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

530

Start

25 Feb 2025

Estimated completion

05 Sep 2031

Extensive-Stage Small Cell Lung Cancer

What is this study about?

This study is looking into new ways to treat a serious type of lung cancer called extensive-stage small cell lung cancer. When cancer is "extensive-stage," it means it has spread quite widely in the body. The study wants to compare two different ways of treating this cancer right from the start.

One treatment being tested is a new combination of medicines called BMS-986489. This combination includes two drugs: BMS-986012 and Nivolumab. Nivolumab is a type of immunotherapy that helps your body's immune system fight cancer. This new combination will be given along with standard chemotherapy drugs called Carboplatin and Etoposide.

The other treatment being compared is a medicine called Atezolizumab, which is already used for this type of cancer. Atezolizumab is also an immunotherapy, and it will also be given with Carboplatin and Etoposide chemotherapy. By comparing these main treatments, researchers hope to find out which one is more effective at treating the cancer and if one has fewer side effects. The goal is always to find better and safer treatments for patients.

Key takeaways

Compares a new drug combination with an existing treatment for lung cancer.
For adults with widespread small cell lung cancer, as their first treatment.
Includes standard chemotherapy with both main treatments.
Aims to find more effective and safer treatment options.
You'll be closely monitored by a medical team.
You can stop participating at any time.

Who may be eligible?

To join this study, participants must have extensive-stage small cell lung cancer that hasn't been treated before with certain therapies. You must also be well enough to carry out your daily activities with little or no help, and doctors need to be able to measure your cancer on scans (like CT or MRI) everywhere except in your brain or nervous system.

However, you won't be able to join if you've already had specific treatments for your extensive-stage small cell lung cancer. Also, you can't participate if you have certain other health conditions, such as brain symptoms caused by your cancer, some serious lung or heart problems, infections, conditions where your immune system attacks your own body (autoimmune diseases), other types of cancer, or a specific kind of nerve damage.

Quick self-check

Do I have extensive-stage small cell lung cancer?
Have I started any previous treatment for this type of widespread lung cancer?
Am I generally well enough to go about my daily activities?
Do I have any other serious heart, lung, or immune system conditions?
Do I have symptoms from cancer that has spread to my brain?
Are my doctors able to measure the size of my cancer on scans (not including brain cancer)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will receive either the new combination drug (BMS-986489 plus chemotherapy) or the standard treatment (Atezolizumab plus chemotherapy). The doctors involved won't know which treatment you are getting, and neither will you. This helps make sure the results are fair.

You will have regular hospital visits for your treatments and to check how you are doing. These visits will include physical examinations, blood tests, and scans (like CT or MRI) to see how the cancer is responding. The doctors will also carefully monitor any side effects you might experience. The total duration of your participation in the study, including follow-up after treatment, will be clearly explained by the study team.

Potential risks and benefits

Participating in any clinical trial has potential benefits and risks. You might benefit from a new treatment that isn't yet widely available, and you'll be closely monitored by a medical team. However, the treatments, including the standard chemotherapy, can have side effects, and it's possible the new medicine might not work for you or could have unknown side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (183)

Southern Cancer Center, PC
Daphne, United States· Recruiting
Local Institution - 0283
Hot Springs, United States· Completed
Florida Cancer Specialists - South
Fort Myers, United States· Recruiting
Mid Florida Hematology and Oncology Center
Orange City, United States· Recruiting
Florida Cancer Specialists - North
St. Petersburg, United States· Recruiting
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, United States· Recruiting
Illinois Cancer Care
Peoria, United States· Recruiting
Local Institution - 0037
Minneapolis, United States· Withdrawn
University of New Mexico Comprehensive Cancer Center
Albuquerque, United States· Recruiting
Duke Cancer Institute
Durham, United States· Recruiting
Sanford Medical Center
Bismarck, United States· Recruiting
Sanford Fargo Medical Center
Fargo, United States· Recruiting

+171 more sites — see the official record for the full list.

Common questions

What is 'extensive-stage small cell lung cancer'?

This means your small cell lung cancer has spread beyond your lung to other parts of your body, or within the chest in a way that makes it harder to treat with local methods like radiation.

What is 'first-line therapy'?

This refers to the very first treatment you receive for your cancer after it has been diagnosed and staged. It's the initial approach to tackling the disease.

What is 'immunotherapy'?

Immunotherapy is a type of cancer treatment that helps your body's own immune system fight the cancer. It boosts your body's natural defenses.

Why are two different treatments being compared?

Researchers want to find out if the new combination treatment works better or has fewer side effects than an existing standard treatment. This helps improve future care for patients.

Will I get chemotherapy?

Yes, both groups in this study will receive the standard chemotherapy drugs Carboplatin and Etoposide, alongside the main study treatments.

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.