Active not recruitingPHASE2INTERVENTIONAL

A Single-arm Trial of Atezolizumab/Platinum/Etoposide for the Treatment of Advanced Large-cell Neuroendocrine Cancer of the Lung

This research study is for people in the UK with a specific type of lung cancer called large-cell neuroendocrine carcinoma (LCNEC) that has advanced or spread. Doctors are investigating a new treatment called Atezolizumab, given alongside the usual chemotherapy drugs (Platinum/Etoposide). The main aim is to understand how well this new combination works and if it's safe and tolerable for patients. This is a Phase 2 trial, meaning it's still in the earlier stages of testing new treatments. Participants will receive the combination therapy, and researchers will carefully monitor their health and the effects of the treatment over time. It's for adults aged 18 and over who haven't had previous treatment for their advanced cancer.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Technische Universität Dresden

Enrolment target

Start

18 Jan 2022

Estimated completion

31 Jan 2029

Large Cell Neuroendocrine Carcinoma of the Lung

What is this study about?

This study is looking into a type of lung cancer called large-cell neuroendocrine carcinoma (LCNEC). If your doctor has told you that your cancer is advanced or has spread, or that current treatments cannot cure it, you might be interested in this research. The study is investigating a new medication called Atezolizumab that will be given along with the standard chemotherapy you would normally receive (called Platinum/Etoposide).

Atezolizumab is a type of immunotherapy. Immunotherapy works by helping your body's own immune system fight cancer cells more effectively. Chemotherapy, on the other hand, uses strong drugs to kill cancer cells. By combining these two approaches, doctors hope to find a more effective way to treat advanced LCNEC. This study is called a 'Phase 2' trial, which means it's one of the earlier steps in testing new treatments. Researchers want to see if this combination causes fewer side effects and if it helps people live longer or improves their quality of life.

The findings from this study will help doctors understand if this combination therapy is a good option for people with LCNEC. It will provide important information about its safety and how well it works. This knowledge can then be used to decide if further, larger studies are needed, potentially leading to new treatment options for patients in the future.

Key takeaways

This study is for adults with advanced large-cell neuroendocrine lung cancer.
It combines Atezolizumab (immunotherapy) with standard chemotherapy.
The aim is to check how well the combination works and its safety.
Participants must not have had previous drug treatment for their advanced cancer.
Regular hospital visits and health checks will be part of the study.

Who may be eligible?

To join this study, you need to meet certain requirements. You must have advanced large-cell neuroendocrine carcinoma of the lung that cannot be cured with current treatments. This includes cases where the cancer has spread within your body. You also must not have had any previous drug treatments for your advanced cancer. If you've had treatment in the past for an earlier stage of cancer, you might still be eligible if it's been at least six months since you finished those treatments.

You also need to be at least 18 years old and generally well enough to take part, as measured by something called an ECOG performance status (which your doctor will explain). Your body also needs to be working well enough, particularly your liver, kidneys, and blood. However, there are some reasons why you might not be able to join. For example, if your brain cancer symptoms are causing problems and are not stable, or if you have certain severe autoimmune diseases or uncontrolled infections. Anyone who has already had Atezolizumab or similar immunotherapy drugs for their cancer cannot join this study.

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.

I have advanced large-cell neuroendocrine lung cancer.
I have not had any previous drug treatment for my advanced cancer.
I am 18 years old or older.
My doctors consider me generally well enough for treatment.
I do not have severe autoimmune diseases or uncontrolled infections.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the new treatment combination of Atezolizumab and standard chemotherapy. The specific schedule for these medications, including how often you receive them and for how long, will be clearly explained by the study team. You will have regular appointments at the hospital or clinic. During these visits, doctors and nurses will monitor your health very closely. This will involve physical examinations, blood tests, and scans (like X-rays or CT scans) to see how the treatment is affecting your cancer and your body. The study team will provide all the details about the number of visits, tests, and the total duration of your participation, including any follow-up appointments after your treatment finishes.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of joining this study is that you might have access to a new treatment combination that could be more effective than standard chemotherapy alone, or help to control your cancer for longer. However, there's no guarantee that the treatment will work for you, and it may not improve your condition. There are also potential risks, as Atezolizumab and chemotherapy can cause side effects. The study team will explain all known and potential side effects in detail. You will be monitored very closely for any side effects, and the medical team will do everything they can to manage them. Importantly, you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (15)

Charité - Universitätsklinikum Berlin Centrum 12, Medizinische Klinik
Verified postcode
Berlin, Germany
Evangelische Lungenklinik
Verified postcode
Berlin, Germany
Klinikum der Universität zu Köln, Klinik I für Innere Medizin
Verified postcode
Cologne, Germany
Universitätsklinikum Dresden, Medizinische Klinik 1
Verified postcode
Dresden, Germany
Klinikum der J.W. Goethe Universität, Medizinische Klinik II
Verified postcode
Frankfurt am Main, Germany
Asklepios Fachkliniken München-Gauting
Verified postcode
Gauting, Germany
LungenClinic Grosshansdorf GmbH
Verified postcode
Großhansdorf, Germany
Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
Verified postcode
Halle, Germany
Thoraxklinik Heidelberg gGmbH, Universitätsklinikum Heidelberg
Verified postcode
Heidelberg, Germany
Lungenklinik Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH
Verified postcode
Hemer, Germany
Lungenfachklinik Immenhausen
Verified postcode
Immenhausen, Germany
Klinikum der Johannes Gutenberg Universität, III. Med. Klinik und Poliklinik
Verified postcode
Mainz, Germany

Common questions

What is large-cell neuroendocrine carcinoma of the lung?

It's a less common type of lung cancer that can grow quickly. This study is specifically for people where the cancer has spread or can't be cured with other treatments.

What is Atezolizumab?

Atezolizumab is an immunotherapy drug that works by helping your body's own immune system find and fight cancer cells.

Will I still get chemotherapy if I join this trial?

Yes, in this study, Atezolizumab is given alongside your usual chemotherapy drugs (Platinum/Etoposide).

What does 'Phase 2' mean for a clinical trial?

Phase 2 means it's an earlier stage of testing a new treatment. Doctors are looking to see if the treatment works and if it's safe for a larger group of patients than in Phase 1.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, without it affecting your future medical care.