Active not recruitingOBSERVATIONAL

A French Real-life Study: EvaluatioN of durvALumab Utilization and Effectiveness for First Line Extensive Stage Small Cell Lung Cancer.

This study explores how a modern cancer treatment, durvalumab, is used and works for patients in France who have a severe form of small cell lung cancer, known as extensive stage. This type of lung cancer is particularly aggressive. For many years, standard treatment involved chemotherapy. Recently, new immune-boosting drugs like durvalumab have shown promise when combined with chemotherapy. While durvalumab has been approved based on clinical trials, this study aims to see how it performs in everyday medical practice with a broader range of patients, rather than just those carefully selected for trials. The goal is to understand its effectiveness and safety in a real-world setting.

At a glance

Status

Active not recruiting

Sponsor

AstraZeneca

Enrolment target

254

Start

14 Nov 2022

Estimated completion

01 Mar 2027

Small Cell Lung Carcinoma

What is this study about?

Small cell lung cancer (SCLC) is a fast-growing and aggressive type of lung cancer. Unfortunately, it often spreads quickly to other parts of the body, which doctors call 'extensive stage.' For a long time, the main treatment for extensive stage SCLC was a combination of chemotherapy drugs. While these treatments could help, new options were always being sought to improve outcomes for patients.

More recently, a new type of drug called immunotherapy has emerged. These drugs work by helping your body's own immune system fight the cancer. Durvalumab is one such immunotherapy drug. It has been approved for use alongside chemotherapy as a first treatment for extensive stage SCLC, based on positive results from clinical trials. These trials showed that adding durvalumab could help people live longer.

This particular study is not a new clinical trial where people are given a new medicine for the first time. Instead, it's looking at how durvalumab is being used in real life in France since its approval. Doctors want to see how well it works and if it's safe for a wider group of patients than those who typically participate in very strict initial clinical trials. This helps them understand the drug's true impact in everyday healthcare.

Key takeaways

Looks at real-world use of durvalumab for advanced small cell lung cancer.
Durvalumab is an immunotherapy drug combined with chemotherapy.
This study helps understand treatment effectiveness outside of strict trial settings.
No change to your medical treatment if you participate.
You must have extensive-stage confirmed small cell lung cancer.
Information from your standard care will be used to help future patients.

Who may be eligible?

To be able to take part in this study, you must be an adult, at least 18 years old. You need to have small cell lung cancer that has been confirmed by tests, and it must be at an 'extensive stage,' meaning it has spread beyond the original location.

Importantly, your doctor must have decided to treat your cancer for the first time with durvalumab combined with chemotherapy. Also, you must be informed about the study and agree to your information being used, or at least not object to it.

However, you cannot join if you have any medical reasons that prevent you from taking durvalumab and its chemotherapy partners. You also can't be in this study if you're already taking part in another research study that tests new treatments for extensive stage small cell lung cancer.

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?
Have you been diagnosed with extensive stage small cell lung cancer?
Has your doctor decided your first treatment will be durvalumab with chemotherapy?
Are you NOT already in another trial for first-line extensive stage SCLC?

Answer every question to see your result.

What does participation involve?

This study is a 'real-life' study, which means it doesn't involve any new treatments or extra visits beyond what your doctor would normally recommend for your care. You will receive durvalumab together with chemotherapy as your first-line treatment, just as your doctor would usually prescribe for your condition. The study will mainly involve collecting and looking at information from your medical records about your treatment, how well you respond, and any side effects you might experience. There are no additional appointments, tests, or procedures required solely for this study. The total duration of your participation will depend on how long you receive the treatment as part of your standard medical care, and how long doctors need to keep track of your progress.

Potential risks and benefits

The potential benefit of participating is that the information gathered from your treatment will help doctors understand how durvalumab works for more people, contributing to better care for future patients. Since you'd be receiving standard care, there are no extra risks beyond those already associated with your prescribed treatment with durvalumab and chemotherapy. These treatments can have side effects, which your doctor will discuss with you. You have the right to withdraw your consent for your medical information to be used in this study at any time, without affecting your medical care.

Locations (34)

Research Site
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Angers, France
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Argenteuil, France
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Avignon, France
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Avignon, France
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Bayonne, France
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Bordeaux, France
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Clermont-Ferrand, France
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Créteil, France
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Dijon, France
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Epagny Metz-Tessy, France
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Évreux, France
Research Site
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Gleizé, France

Common questions

What kind of cancer is this study about?

It's about 'extensive stage small cell lung cancer,' which is an advanced form of a fast-growing lung cancer.

What is durvalumab?

Durvalumab is a modern immunotherapy drug that helps your body's immune system fight cancer cells.

Will I get different treatment if I join this study?

No, you will receive the standard treatment your doctor recommends, which includes durvalumab and chemotherapy.

Why is this study being done?

It's to see how durvalumab works in real-world situations with a wider range of patients, not just those in strict clinical trials.

What if I don't want my information used?

You can let your doctor know you don't want your information included in the study, and it won't affect your care.