Active not recruitingOBSERVATIONAL

A Study Investigating the Outcomes and Safety of Atezolizumab Under Real-World Conditions in Patients Treated in Routine Clinical Practice

This study is designed to understand how a cancer medicine called atezolizumab (pronounced: ah-teh-zoh-LIZ-oo-mab) works for patients in everyday hospital settings, outside of a strict clinical trial. It will look at people with specific cancers like bladder cancer, lung cancer, and liver cancer, where atezolizumab is already approved for use. Researchers will gather information on how well the treatment works and if there are any side effects, simply by observing patients receiving their usual care. This helps doctors learn more about the drug's performance in a broader group of patients than those typically in initial trials.

At a glance

Status

Active not recruiting

Sponsor

Hoffmann-La Roche

Enrolment target

2,756

Start

07 Feb 2019

Estimated completion

31 Jul 2026

Urothelial Carcinoma Non-Small Cell Lung Cancer Small Cell Lung Cancer Hepatocellular Carcinoma

What is this study about?

Imagine a new medicine is approved for use. Before that happens, it goes through very strict trials with a select group of patients. Once it's available, doctors use it in their daily practice with many different kinds of people who fit the treatment criteria.

This study is designed to watch how atezolizumab works for patients in this 'real world' setting. It's not a typical experiment where people are given a new, unproven drug. Instead, doctors are simply observing patients who are already receiving atezolizumab as part of their standard cancer treatment for conditions like bladder cancer, various types of lung cancer, and liver cancer. The main goal is to collect information on how effective the drug is and any side effects people experience when it's used in routine care.

The information gathered from this study is really important. It helps doctors and researchers understand the actual benefits and risks of atezolizumab in a wider range of patients than those in earlier, more controlled studies. This helps to improve our understanding of the drug and how best to use it for different cancer types.

Key takeaways

This study observes real-world use of a cancer drug called atezolizumab.
It covers advanced bladder, lung, and liver cancers.
Participation means your medical information is used, but your care stays the same.
No extra appointments or changes to your treatment medication.
The study helps doctors understand the drug's effects in many patients.

Who may be eligible?

You might be able to join this study if you are an adult who has been diagnosed with certain types of cancer, specifically advanced bladder cancer, some forms of lung cancer (non-small cell or small cell), or a certain type of liver cancer, and your doctor believes atezolizumab is the right treatment for you.

To be included, it must be your first time receiving atezolizumab, and the decision to give you this medicine must have been made by your doctor as part of your standard care, before the study began. This means your doctor has decided atezolizumab is the best treatment option based on your condition and current medical guidelines, not because of the study.

You would not be able to join if you are receiving other cancer treatments at the same time as atezolizumab, or if you are specifically a patient with advanced bladder cancer who is receiving atezolizumab as a very first treatment for locally advanced/metastatic stage because you cannot have cisplatin chemotherapy. Essentially, you're eligible if you're getting atezolizumab exactly as your doctor normally prescribes it, following its approved uses.

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 an adult (18 or older)?
Have you been diagnosed with advanced bladder cancer, certain lung cancers, or a specific type of liver cancer?
Has your doctor decided to treat you with atezolizumab as part of your normal care?
Is this your first time receiving atezolizumab?
Are you NOT receiving other cancer treatments at the same time as atezolizumab?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you won't be asked to do anything extra or different from your usual medical care. You will receive atezolizumab as prescribed by your doctor, and all your regular appointments, tests, and follow-ups will continue as planned. The study researchers will simply collect information from your existing medical records about how your treatment is going, how effective it is, and any side effects you might experience. There are no additional visits, specific assessments, or changes to your medication schedule that are solely for the purpose of this study. Your total duration of participation will be determined by how long you remain on atezolizumab treatment as part of your standard care.

Potential risks and benefits

Since this study simply observes patients receiving standard care, there are no additional benefits or risks beyond those associated with your normal atezolizumab treatment. The potential benefits are those of the drug itself, which your doctor would have discussed with you, like slowing cancer growth or improving your quality of life. The potential risks are the known side effects of atezolizumab, which your medical team will monitor as part of your care. Taking part will not change your treatment or how it's given. You are always free to withdraw from contributing information to the study at any time without affecting your medical care.

Locations (258)

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

Hospital Universitario Austral
Verified postcode
Buenos Aires, Argentina
Lucen S.A.
Verified postcode
Buenos Aires, Argentina
Consultorio Privado Korbenfeld
Unverified
CABA, Argentina
Hospital Italiano de Buenos Aires
Unverified
Ciudad Autonoma Buenos Aires, Argentina
Sanatorio Allende
Verified postcode
Córdoba, Argentina
Sanatorio de la Mujer
Verified postcode
Rosario, Argentina
Fundacion Koriza
Verified postcode
Santa Rosa, Argentina
Klinikum Klagenfurt
Verified postcode
Klagenfurt, Austria
Landesklinikum Krems
Verified postcode
Krems, Austria
Salzkammergut-Klinikum Voecklabruck
Verified postcode
Vöcklabruck, Austria
Klinikum Wels-Grieskirchen
Verified postcode
Wels, Austria
AZ KLINA
Verified postcode
Brasschaat, Belgium

Common questions

What is atezolizumab?

Atezolizumab is a cancer medicine used to treat certain types of cancer, often by helping your body's immune system fight the cancer cells.

Will my treatment change if I join this study?

No, your treatment will not change. You will receive the same care and medication (atezolizumab) as your doctor planned, completely independently of the study.

Why is this study being done?

The study aims to learn how atezolizumab works in real people under normal hospital care, gathering information about its effects and safety in a broader patient group.

Do I have to do extra tests or appointments?

No, you won't have any extra appointments or tests just for this study. The researchers will use information from your usual medical records.

Can I stop participating in the study at any time?

Yes, you can choose to stop your information being used in the study at any point, and this will not affect your medical care.