Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase III, Randomized, Double-Blinded, Placebo-Controlled Study of Tiragolumab, an Anti-Tigit Antibody, in Combination with Atezolizumab Compared with Placebo in Combination with Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer

This study is for adults aged 18 and over who have a specific type of advanced lung cancer (non-small cell lung cancer) that has spread or can't be removed by surgery, and hasn't been treated yet. Researchers are testing a new drug called tiragolumab alongside an existing cancer medicine, atezolizumab (Tecentriq). Some participants will receive tiragolumab with atezolizumab, while others will get a dummy drug (placebo) with atezolizumab. This is to see if adding tiragolumab helps people live longer and slows down their cancer more effectively. The study is 'double-blinded,' meaning neither you nor your doctors will know which treatment you are receiving, to ensure fair results. The main goals are to see how long people live and how long their cancer stays without getting worse.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

192

Start

19 Aug 2024

Non-small cell lung cancer (NSCLC)

What is this study about?

This clinical trial is designed for people who have a type of lung cancer called non-small cell lung cancer (NSCLC) that is advanced, meaning it has either spread to other parts of the body or cannot be completely removed by surgery. Importantly, this study is for those who haven't had previous treatment for this advanced stage of their cancer. The cancer cells must also show a certain marker called PD-L1.

The study aims to find out if adding a new experimental drug, tiragolumab, to a standard cancer treatment, atezolizumab (also known as Tecentriq), works better than atezolizumab alone. Atezolizumab is an immunotherapy that helps your body's immune system fight cancer. Tiragolumab is also an anti-cancer drug that works by blocking a different target called TIGIT, which may help the immune system attack cancer more effectively. By combining these two treatments, researchers hope to see if they can improve how well people respond to treatment, extend their lives, and maintain their quality of life.

This is a 'Phase III' study, which means it's a large, final stage trial testing a new treatment that has shown promise in earlier studies. Participants will be randomly assigned to one of two groups: one group will receive tiragolumab with atezolizumab, and the other will receive a placebo (a dummy drug that looks like tiragolumab but contains no active medicine) along with atezolizumab. Neither you nor your study doctor will know which treatment you are getting. This 'double-blinded' approach helps ensure the results are as fair and accurate as possible, as it prevents any bias from affecting the study's findings.

Key takeaways

This study is for advanced non-small cell lung cancer that hasn't been treated before.
It tests a new drug (tiragolumab) added to an existing immunotherapy (atezolizumab).
Some participants will receive the new drug, others a dummy drug (placebo), both with atezolizumab.
The study aims to see if the new combination helps people live longer and slows cancer growth.
It's a large, important stage (Phase III) trial to confirm treatment effectiveness.
Both men and women aged 18 and over can participate if they meet specific health criteria with doctors finding PD-L1 marker.

Who may be eligible?

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

Key to eligibility is having non-small cell lung cancer that is considered 'locally advanced unresectable,' meaning it has grown too much to be removed with surgery, or 'metastatic,' which means it has spread to other parts of your body. Also, you must not have received any prior treatment specifically for this advanced stage of your lung cancer. Doctors will also check for a specific marker on your cancer cells called PD-L1.

There will be other detailed medical checks to make sure the treatment is safe for you and that you meet all the study's requirements. These checks might include your general health, other medical conditions you have, and the results of certain blood tests.

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 advanced non-small cell lung cancer that has not been treated before?
Has your cancer either spread or cannot be removed by surgery?
Have your doctors confirmed that your cancer cells have the PD-L1 marker?
Are you generally well enough to take part in a clinical trial?
Are you able to attend regular clinic appointments for treatment and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will likely have regular visits to the clinic. These visits will involve various assessments such as physical examinations, blood tests, and scans (like CT or MRI scans) to track your cancer and check your overall health. You will receive the study medications (either tiragolumab plus atezolizumab, or placebo plus atezolizumab) through a drip, which is an infusion directly into a vein. The frequency and duration of these infusions will be set out by the study doctors.

You will also be asked to complete questionnaires about your quality of life and how you are feeling, which helps researchers understand the impact of the treatment on your daily life. The study will monitor for any side effects experienced. Regular follow-up appointments will continue even after you stop receiving the study medication, to keep track of your health and any long-term effects. The total duration of your participation will depend on how you respond to treatment and could last for several years, though treatment might stop earlier if your cancer progresses or if you experience significant side effects.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to promising new treatments before they are widely available. While tiragolumab and atezolizumab aim to help fight cancer, there's no guarantee that you will personally benefit from the study treatment. There are also potential risks, including side effects from the medications, which can vary from mild to severe, and may be currently unknown. Although researchers will closely monitor your health, there's always a possibility that the treatment might not be effective for your cancer. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

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

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Unverified
Germany
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Unverified
Hungary
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Unverified
Italy
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Unverified
Poland
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Unverified
Spain
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Unverified
Netherlands
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Unverified
Austria
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Unverified
Greece

Common questions

What is non-small cell lung cancer (NSCLC)?

It's the most common type of lung cancer. This study focuses on advanced NSCLC that has spread or can't be removed by surgery.

What does 'double-blinded' mean?

It means neither you nor your doctor will know whether you are receiving the active new drug (tiragolumab) or a dummy drug (placebo). This helps ensure fair and accurate study results.

What are Tiragolumab and Atezolizumab?

Atezolizumab (Tecentriq) is an approved immunotherapy that helps your immune system fight cancer. Tiragolumab is an experimental anti-cancer drug being tested in combination with atezolizumab.

Why is 'PD-L1-selected' important?

It means your cancer cells are checked for a specific marker called PD-L1. This marker helps doctors understand if certain immunotherapies are more likely to work for your cancer.

What is a 'placebo'?

A placebo is an inactive substance that looks just like the real medicine but contains no active drug. It's used to compare the effects of the active drug accurately.