Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Carboplatin and Etoposide with or Without Tiragolumab (Anti-Tigit Antibody) in Patients with Untreated Extensive-Stage Small Cell Lung Cancer

This important study is testing new treatments for people with a difficult form of lung cancer called extensive-stage small cell lung cancer. Doctors want to see if adding a new drug, tiragolumab, to a combination of chemotherapy (carboplatin and etoposide) and an existing cancer drug, Tecentriq, can help patients live longer and keep their cancer from growing. The study compares this new drug combination with the standard treatment (chemotherapy and Tecentriq) plus a dummy drug (placebo). It's a 'Phase III' study, which means it’s looking to confirm if the new treatment is better than what’s already available. Researchers will carefully check how well patients respond to the treatments, how long they live, and any side effects they might experience. This helps doctors find the best treatments for patients in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

23 Sep 2024

Small cell lung cancer (SCLC)

What is this study about?

This study is focused on improving treatments for a serious type of lung cancer known as extensive-stage small cell lung cancer. This means the cancer has spread beyond the lung where it started. Doctors are always looking for better ways to help patients with this condition, and that's where this study comes in. They are investigating a new drug called tiragolumab.

The study combines tiragolumab with a standard treatment often used for this cancer: chemotherapy (carboplatin and etoposide) and another cancer drug called Tecentriq. Participants will either receive this full new combination or the standard treatment with a 'dummy' drug (a placebo) instead of tiragolumab. The main goal is to see if adding tiragolumab can help patients live longer and stop the cancer from growing for a longer time.

This is a 'Phase III' study, which is the final stage of testing before a new treatment can be approved for widespread use. This means the treatments being tested have already shown some promise in earlier studies. The researchers will closely monitor how patients respond, looking at things like how much the cancer shrinks, how long it takes for the cancer to possibly grow again, and how patients feel overall. This detailed information will help determine if this new treatment approach is a valuable option for people with small cell lung cancer.

Key takeaways

This study is for people with extensive-stage small cell lung cancer.
It tests a new drug (tiragolumab) added to standard chemotherapy and Tecentriq.
The main aim is to see if this new combination helps patients live longer or keeps cancer from growing.
It's a Phase III study, comparing the new treatment with a placebo.
Participants will receive regular medical checks and treatments in a hospital setting.

Who may be eligible?

To join this study, you must be 18 years old or older. The study is open to both men and women.

You would need to have been recently diagnosed with extensive-stage small cell lung cancer and not yet started any treatment for it. The doctors will also check other health factors to make sure that the study treatment is suitable and safe for you.

There might be other specific health requirements or conditions that would mean you can't take part. It's really important to discuss all your medical history and current health with the study doctor to see if this study is the right fit for you.

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 18 years old or older?
Have you been diagnosed with extensive-stage small cell lung cancer?
Have you *not* had any treatment for this cancer yet?
Are you able to travel to study appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to one of two groups: either you'll receive the new drug tiragolumab alongside chemotherapy and Tecentriq, or you'll receive a placebo (dummy drug) with chemotherapy and Tecentriq. Neither you nor your study doctor will know which group you are in, which helps ensure the results are fair.

You will have regular hospital visits for your treatments, which are given through an IV drip. During these visits, the medical team will perform various tests such as blood tests, scans, and physical exams to monitor your health and how the treatment is working. They will also ask you questions about how you are feeling and any side effects you might be having.

The study also involves collecting samples to understand how the drugs work in your body and to check for any reactions. You will also be asked to complete questionnaires about your quality of life. The treatments will continue for a set period, and you'll have follow-up visits even after you finish treatment to monitor your long-term health. The exact duration of your participation will be explained by the study team.

Potential risks and benefits

Taking part in a clinical trial can offer potential benefits, such as access to new treatments before they are widely available, and dedicated medical care from a study team. The hope is that the new treatment combination explored in this study might improve outcomes for patients with small cell lung cancer. However, there are also potential risks involved, including side effects from the medications, which could range from mild to serious. The study team will closely monitor you and manage any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Greece
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Unverified
Italy
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Unverified
Poland

Common questions

What is small cell lung cancer?

It's a serious and fast-growing type of lung cancer that commonly spreads to other parts of the body.

What does 'extensive-stage' mean?

It means the cancer has spread from where it started in the lung to other areas, making it more advanced.

What is a 'placebo'?

A placebo is a 'dummy' drug or treatment that looks the same as the real treatment but doesn't contain any active medicine. It helps researchers compare the effects of the new drug fairly.

What is a 'Phase III' study?

It's the final stage of testing a new treatment, comparing it to existing treatments to see if it's better and safer before it can be approved for wider use.

Will I know if I'm getting the new drug?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know which treatment you are receiving until the study is over.