Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase II, Randomized, Blinded, Placebo-Controlled Study of Tiragolumab, an Anti- TIGIT Antibody, in Combination with Atezolizumab in Chemotherapy-Naive Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer

This research study is investigating a new treatment approach for a kind of lung cancer known as non-small cell lung cancer, specifically in patients who haven't had chemotherapy before. The study combines two medicines: tiragolumab, which is a new experimental drug, and atezolizumab (brand name Tecentriq), an approved cancer treatment. Researchers want to understand if this new combination shrinks tumours or stops the cancer from growing for longer periods, compared to just atezolizumab with adummy treatment. This is a 'Phase II' study, which means it's an earlier stage of research designed to gather more information on how safe and effective the new drug combination is.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Genentech Inc.

Enrolment target

Start

06 May 2024

Non-small cell lung cancer (NSCLC)

What is this study about?

This study is about finding new ways to treat a common type of lung cancer called non-small cell lung cancer (NSCLC). This trial is for people whose cancer is advanced or has spread, and who haven't started chemotherapy yet. Researchers are testing a new experimental drug called tiragolumab alongside an existing cancer medicine called atezolizumab (also known as Tecentriq).

Atezolizumab is a type of immunotherapy that helps your own body's immune system fight cancer. Tiragolumab is also an immunotherapy that works in a similar way, by helping to 'unblock' the immune system so it can better attack cancer cells. The idea is that combining these two treatments might work better than one alone. To find out, some people in the study will get the new drug combination, while others will get atezolizumab plus a dummy treatment (placebo) to compare the results fairly.

The main goals of the study are to see how many people's tumours shrink or disappear, and how long people live without their cancer growing worse. Researchers will also be carefully checking for any side effects and how people generally feel. This will help them understand if this new combination could be a useful treatment option in the future.

Key takeaways

Tests a new immunotherapy combination for advanced lung cancer.
For people who haven't had chemotherapy for their lung cancer yet.
Compares a new drug (tiragolumab) plus atezolizumab against atezolizumab alone.
Mainly looks at how well the cancer responds and how long it takes for the cancer to grow.
Involves regular hospital visits for treatments and checks.

Who may be eligible?

To join this study, you generally need to be an adult, aged 18 years or older, with a diagnosis of non-small cell lung cancer that is locally advanced (meaning it has grown significantly in the area) or has spread to other parts of your body (metastatic).

Importantly, you must not have received any chemotherapy for your lung cancer before joining this study. Both men and women can take part. There will be other specific medical checks to make sure the study is safe and right for you, but these are the main starting points.

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?
Do you have non-small cell lung cancer?
Has your lung cancer grown locally or spread to other parts of your body?
Have you *not* received any chemotherapy for your lung cancer yet?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to one of two groups: one group will receive a combination of tiragolumab and atezolizumab, and the other will receive atezolumab with a dummy treatment (placebo). Neither you nor your doctor will know which treatment you are receiving. The treatments are given as drips (infusions).

You'll have regular hospital visits for your treatments, blood tests, physical exams, and scans to monitor your health and how the treatment is affecting your cancer. Doctors will also ask you about any side effects you might be experiencing. The study will continue as long as the treatment is helping and you are feeling well enough, with ongoing follow-up to check your health over time.

Potential risks and benefits

Potential benefits of taking part might include receiving a new experimental treatment that could help control your cancer. However, there's no guarantee the treatment will work for you, and it's possible you could experience side effects, some of which may be serious, from the medications. We don’t know all the possible side effects of new drugs. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Spain
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Unverified
France

Common questions

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

It's the most common type of lung cancer. This study is for people with NSCLC that has advanced or spread.

What are tiragolumab and atezolizumab?

Atezolizumab (Tecentriq) is an approved immunotherapy that helps your immune system fight cancer. Tiragolumab is a new, experimental immunotherapy being tested to see if it makes atezolizumab work even better.

What does 'randomised' mean in a study?

It means you will be put into a treatment group by chance, like flipping a coin. This helps make sure the study results are fair.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks like the real drug but contains no active medicine. It helps researchers fairly compare the new treatment's effects.

Why is this a 'Phase II' study?

Phase II studies are an earlier stage of research. They focus on finding out if a new treatment is safe and shows promise before being tested in much larger groups of people.