Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase II, Single-Arm Study of Atezolizumab in Patients with Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer who have not Progressed after Platinum-Based Concurrent Chemoradiation

This research study is looking at a medicine called Tecentriq for people with a specific type of lung cancer known as non-small cell lung cancer (NSCLC). This is for patients whose cancer has responded well to initial treatment with chemotherapy and radiotherapy, and hasn't started growing again. The main goal is to find out if Tecentriq can prevent the cancer from growing or spreading for at least 12 months. Researchers will also look at how long people live, how many see their cancer shrink, and how long the treatment effect lasts. This is a Phase II study, which means it builds on earlier research to gather more information about how effective and safe the treatment is.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

19 Feb 2024

Non-Small Cell Lung Cancer (NSCLC)

What is this study about?

This study is focused on a specific type of lung cancer called Non-Small Cell Lung Cancer (NSCLC). It's for patients whose cancer is considered 'locally advanced' – meaning it has grown within the chest area but hasn't spread to distant parts of the body. Importantly, this study is for those who have already had standard treatment with chemotherapy and radiotherapy, and whose cancer hasn't progressed or started growing again after these initial treatments. The new medicine being tested is called Tecentriq.

The main aim of this study is to see if Tecentriq can help keep the cancer from growing or spreading for at least 12 months. This is known as 'progression-free survival'. Researchers will carefully track how patients respond to the treatment and measure whether the cancer stays stable, shrinks, or grows. They will also look at other important things like how long patients live, whether the treatment causes the cancer to shrink (this is called an 'objective response'), and how long any benefits from the treatment last.

This is a Phase II study, which means it’s a crucial step in testing new medicines. It helps researchers gather more information about how well a drug works and its safety, building on earlier research before it can be considered for wider use. By taking part, patients could contribute to important knowledge that might help others with NSCLC in the future.

Key takeaways

This study is for locally advanced NSCLC that hasn't spread.
It's testing a drug called Tecentriq after standard chemotherapy and radiotherapy.
The main goal is to see if Tecentriq can keep cancer from growing for at least 12 months.
Participation involves regular clinic visits for treatment, tests, and scans.
You can withdraw from the study at any time.
You will be closely monitored for side effects.

Who may be eligible?

To join this study, you would typically need to be an adult, aged at least 18 years old.

You should have a specific type of lung cancer called Non-Small Cell Lung Cancer (NSCLC) that is considered 'locally advanced' and has not spread widely in your body. A key requirement is that you must have already finished chemotherapy and radiotherapy treatment, and your cancer has not gotten worse since those treatments.

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 locally advanced Non-Small Cell Lung Cancer?
Have you already completed chemotherapy and radiotherapy for your cancer?
Has your cancer not grown or progressed since your last treatments?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the study medication, Tecentriq, which is given through a drip into your vein. The exact schedule of your visits and treatments would be explained by the study team, but typically, you would have regular appointments for check-ups, blood tests, and scans to monitor your health and how your cancer is responding. These checks are important to see if the treatment is working and to monitor for any side effects.

The study team will explain how long you might be on the treatment and how often you will need to attend. Even after you stop receiving the treatment, there will likely be follow-up appointments to continue monitoring your health over a period of time. The total duration of your participation would be fully discussed with you before you agree to join.

Potential risks and benefits

Taking part in any clinical study comes with potential benefits and risks. You might benefit from receiving Tecentriq, which could help stop your cancer from growing or spreading for longer. However, there's no guarantee the treatment will work for everyone, and it might not work for you. Like all medicines, Tecentriq can have side effects, and the study team will explain these to you in detail. Your safety is a top priority, and you'll be closely monitored for any reactions. Remember, you can choose to leave 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.

—
Unverified
Slovenia
—
Unverified
Spain

Common questions

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

It's the most common type of lung cancer. This study is for a specific stage where the cancer has grown in the lung area but hasn't spread far.

What is Tecentriq?

Tecentriq is a type of immunotherapy. It works by helping your body's immune system fight cancer cells. It's given as a drip into your vein.

What does 'progression-free survival' mean?

It refers to the length of time you live without your cancer growing or getting worse. This study wants to see if Tecentriq can extend this time.

Will I get other cancer treatments during the study?

This study is for patients who have already completed their initial chemotherapy and radiotherapy. The study drug will be the main treatment you receive during the trial.

Who decides if the treatment is working?

Both the study doctors and an independent group of experts will review your scans and test results to decide if the cancer is responding to the treatment.