Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

A Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study of Tiragolumab in combination with Atezolizumab plus Pemetrexed and Carboplatin/Cisplatin versus Pembrolizumab plus Pemetrexed and Carboplatin/Cisplatin in Patients with previously Untreated Advanced Non-Squamous Non-Small-Cell Lung Cancer

This study is for people with a type of advanced lung cancer called non-squamous non-small cell lung cancer that hasn't been treated before. It's testing new ways to fight the cancer. The main goal is to compare two different treatment plans. Both plans include standard anti-cancer drugs (Pemetrexed and Carboplatin/Cisplatin) and an immunotherapy drug (either Atezolizumab or Pembrolizumab). One of the plans also adds a new drug called Tiragolumab. Researchers want to see which combination is better at shrinking tumours, stopping the cancer from growing, and helping people live longer. They will also look at how patients feel and their quality of life, as well as any side effects.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

149

Start

07 Jun 2024

Non-squamous non-small cell lung cancer (NSCLC)

What is this study about?

This study is for people who have advanced non-squamous non-small cell lung cancer and haven't had treatment for it yet. This type of lung cancer is quite common. The study aims to find out if a new drug combination can work better than existing treatments.

Researchers are comparing two different treatment groups. Both groups will receive a standard type of chemotherapy (Pemetrexed and Carboplatin or Cisplatin) and a type of immunotherapy. Immunotherapy helps your body's own immune system fight the cancer. One group will get an immunotherapy drug called Atezolizumab (also known as Tecentriq) along with a new drug called Tiragolumab. The other group will get a different immunotherapy drug called Pembrolizumab (also known as Keytruda) without Tiragolumab. Some people in the Atezolizumab group might also receive a dummy medicine (placebo) instead of Tiragolumab, so researchers can properly compare the effects of Tiragolumab.

The main things the researchers want to find out are whether the treatments can shrink the tumours, stop the cancer from growing, and help people live longer. They'll also carefully track any side effects and how the treatments affect people's daily lives and general wellbeing. This information will help doctors understand if these new combinations are a good option for future patients.

Key takeaways

This study is for untreated advanced non-squamous non-small cell lung cancer.
It compares two treatment combinations, one including a new drug (Tiragolumab).
It assesses tumour shrinkage, cancer growth, survival, and quality of life.
Participation involves regular hospital visits for treatment and tests.
Potential benefits include access to new treatments; risks include unknown side effects.
You can withdraw from the study at any time without penalty.

Who may be eligible?

To join this study, people need to be at least 18 years old. Both men and women can take part.

This study is specifically looking for people who have been diagnosed with advanced non-squamous non-small cell lung cancer. This means the cancer has spread beyond the original site or is too advanced for surgery. Importantly, you must not have received any previous treatment for this advanced stage of your lung cancer.

There will be other detailed medical checks to make sure the study is safe and suitable for your particular health situation. If you are interested, your doctor will be able to check all the specific requirements.

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-squamous non-small cell lung cancer?
Have you not received any previous cancer treatment for your advanced lung cancer?
Are you able to travel to study appointments regularly?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to one of the treatment groups, meaning a computer will decide which treatment you get, like flipping a coin. You, and often your study doctor, won't know which specific treatment you're receiving (this is called 'double-blind').

You will receive your assigned treatment, which involves infusions (medicine given through a drip). You'll have regular hospital visits for these treatments and to have various tests, such as blood tests, scans (like CT scans), and check-ups with the study team. These tests help track how well the treatment is working and monitor your health.

During the study, you'll also be asked to complete questionnaires about how you are feeling, your quality of life, and any symptoms you might have. This helps the researchers understand the impact of the treatment on your daily life. The study will continue for a period, and you'll have follow-up appointments even after your main treatment finishes, to monitor your long-term health and any ongoing effects. The total duration of your participation will depend on how your treatment progresses and the long-term follow-up schedule.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving new treatments that aren't widely available yet, which could improve your condition. You will also be closely monitored by a team of medical experts. However, there are also potential risks, as new treatments can have side effects that aren't fully known, or they may not work as well as hoped. You might experience side effects from the drugs involved, and these will be carefully tracked. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

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
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Unverified
Denmark
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Unverified
Belgium
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Unverified
Germany
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Unverified
Poland

Common questions

What is 'non-squamous non-small cell lung cancer'?

It's a common type of lung cancer, and 'non-squamous' describes how the cancer cells look under a microscope.

What is immunotherapy?

Immunotherapy is a treatment that helps your body's own immune system find and fight cancer cells more effectively.

What does 'randomized' mean?

It means you're put into a treatment group by chance, like drawing names from a hat. This makes the study fair.

What does 'double-blind' mean?

It means that neither you nor your study doctor will know which specific treatment you are receiving, to ensure unbiased results.

Can I stop being part of the study if I want to?

Yes, you can leave the study at any time, for any reason, and it won't affect your future medical care.