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RecruitingOBSERVATIONAL

Real-World Data on the Treatment of Lung Cancer Patients With the Immune-Checkpoint Inhibitor Tislelizumab

This study, called ReWoLuTe, is collecting information about how a lung cancer treatment, Tislelizumab, is used in everyday healthcare across Germany and Austria. Researchers want to understand how people with different types of lung cancer react to this medication in real-life situations, not just in strict trial settings. They'll be looking at how long people live, their treatment plans, how safe the medicine is, and how it affects their quality of life. This helps doctors understand better how Tislelizumab works for a wider range of patients than those typically included in initial studies. The study will follow patients for up to five years.

At a glance

Status
Recruiting
Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Enrolment target
240
Start
23 Dec 2025
Estimated completion
23 Jan 2033

What is this study about?

Imagine you have lung cancer, and your doctor suggests a treatment called Tislelizumab. This study, called ReWoLuTe, is designed to see how this medicine works for people like you, in everyday clinics and hospitals in Germany and Austria. Doctors already know a lot about Tislelizumab from earlier studies, but what they want to learn now is how it performs when given to a much wider group of people with different health conditions and lifestyles – essentially, real-world experience.

The main goal is to understand how effective Tislelizumab is at helping people with lung cancer live longer. But it’s not just about that; the study will also look at how treatments are planned, if the medicine causes any side effects, and how it affects your overall well-being and daily life. By gathering this information from many patients over several years, doctors can get a clearer picture of who benefits most from Tislelizumab and how best to use it.

This study is important because it fills in gaps that standard clinical trials might miss. Clinical trials are very controlled, but in real life, patients are diverse. This 'real-world data' helps ensure that treatments are suitable and effective for more people. So, if you're taking Tislelizumab, your experience could help improve care for many others with lung cancer.

Key takeaways

  • This study looks at how Tislelizumab, a lung cancer medicine, works in everyday care.
  • It aims to understand real-world results for different lung cancer patients.
  • Data collected will include survival, safety, and quality of life.
  • Participation means your routine medical information will be used for research.
  • The study will follow patients for up to five years.
  • It helps doctors understand the medicine better for future patients.

Who may be eligible?

This study is looking for adults aged 18 or over who have been diagnosed with certain types of lung cancer and whose doctor has already decided that Tislelizumab is the right treatment for them.

Specifically, you might be eligible if you have a certain type of non-small cell lung cancer (NSCLC) that's being removed by surgery, or if your NSCLC is more advanced. It also includes people with a widespread form of small cell lung cancer (SCLC) who haven't had treatment for it yet. The key thing is that your doctor has already decided to treat your lung cancer with Tislelizumab according to its approved uses.

The study is interested in both NSCLC that has spread locally or more widely, and SCLC that has spread a lot. There are specific details about the type of cancer, previous treatments, and certain genetic markers your doctor would check to see if you fit the study's 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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with lung cancer (either non-small cell or small cell)?
  3. Has your doctor already decided that Tislelizumab is the right treatment for your lung cancer?
  4. Are you receiving Tislelizumab for an approved reason for your type of lung cancer?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't be given new treatments or asked to have extra tests just for the study. Instead, the study will simply collect information about your health and treatment as part of your usual care. This includes regular check-ups with your doctor and any tests you'd normally have. This information will help researchers understand how Tislelizumab works for people like you.

The study will follow your progress during your regular treatment and continue to gather information for up to five years. This long-term follow-up helps to see the lasting effects of the treatment. There might also be a chance to provide tissue samples, if available, for additional research, but this is optional.

Potential risks and benefits

Taking part in this study may not directly benefit you, as it mainly involves observing your standard treatment rather than providing new interventions. However, the information gathered from your journey can greatly help future patients with lung cancer by improving understanding of how Tislelizumab works in real life. As this is an observational study, there are no additional medical risks beyond those of your standard treatment with Tislelizumab. You are free to withdraw from the study at any time without affecting your medical care.

Locations (2)

  • Universitätsklinikum St. Pölten - Lilienfeld, Karl Landsteiner Privatuniversität für Gesundheitswissenschaften
    Verified postcode
    Sankt Pölten, Austria· Not yet recruiting
  • Krankenhaus Nordwest
    Verified postcode
    Frankfurt am Main, Germany· Recruiting

Common questions

What is Tislelizumab?

Tislelizumab is a medicine used to treat certain types of lung cancer.

What kind of lung cancer patients are included?

The study includes adults with specific types of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC).

Do I have to do anything differently if I join?

No, you just continue with your usual medical appointments and treatment with Tislelizumab as planned by your doctor.

How long will the study follow me?

The study will collect information about your care for up to five years.

Will I get special treatment if I join?

No, you will receive your standard care and treatment with Tislelizumab, just as your doctor has prescribed.

How to find out more

Akin Atmaca, PD Dr. med.

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Real-World Data on the Treatment of Lung Cancer Patients Wit…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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