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RecruitingPHASE3INTERVENTIONAL

A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC)

This study is looking at a new medicine called Ris-Rez for people with small cell lung cancer that has returned after initial treatment. Ris-Rez works by targeting specific proteins on cancer cells to stop them growing and spreading. Researchers want to find out if Ris-Rez is more effective than standard treatment, topotecan, at shrinking tumours or making them disappear completely, and if it helps people live longer. They will also carefully compare the safety and side effects of both medicines. Participants will be randomly assigned to receive either Ris-Rez or topotecan to help scientists understand which treatment offers the best outcomes for patients.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
GlaxoSmithKline
Enrolment target
420
Start
11 Aug 2025
Estimated completion
28 Sep 2029

What is this study about?

This study is designed for individuals who have small cell lung cancer that has come back (relapsed) after their first treatment. This type of lung cancer can be challenging, and doctors are always looking for better ways to treat it. The new medicine being tested, Ris-Rez, is designed to specifically target certain proteins on cancer cells. Think of it like a key that fits a lock only found on cancer cells, helping the medicine to attack the cancer more precisely and potentially reduce its ability to grow and spread.

The main goals of this research are to see if Ris-Rez works better than the current standard treatment, called topotecan. The researchers want to know if Ris-Rez can make tumours smaller or if they disappear entirely. They also want to find out if people who receive Ris-Rez live longer compared to those receiving topotecan. Safety is also a very important part of the study; the team will be closely monitoring any side effects to understand how well people tolerate Ris-Rez compared to topotecan, and to learn about the main side effects of both treatments.

To make sure the results are fair and accurate, participants will be put into one of two groups by chance (like flipping a coin). One group will receive the new medicine, Ris-Rez, and the other will receive topotecan. This way, researchers can directly compare the effects of both treatments. Taking part in a study like this helps us discover new and better ways to treat cancer, benefiting future patients.

Key takeaways

  • Tests a new medicine (Ris-Rez) for relapsed small cell lung cancer.
  • Compares Ris-Rez to standard treatment (topotecan).
  • Aims to see if Ris-Rez shrinks tumours or helps people live longer.
  • Carefully checks the safety and side effects of both medicines.
  • Participants are assigned to treatments randomly to ensure fair results.

Who may be eligible?

To join this study, you must be an adult aged 18 or over and have a confirmed diagnosis of small cell lung cancer that has spread (extensive-stage) and has come back after your first platinum-based chemotherapy. You must have received that first treatment for at least two cycles, and your cancer must have progressed more than 30 days afterwards. You'll also need to have at least one measurable tumour for doctors to track, and your general health and organ function must be good enough to take part.

There are also reasons why you might not be able to join. For example, if you had a different type of small cell lung cancer at diagnosis, or if your cancer has spread to your brain causing symptoms. You also can't have certain other serious health issues, like uncontrolled heart problems or active infections, or have received specific types of previous cancer treatments that target B7-H3 or use a similar drug type to Ris-Rez.

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. Has your small cell lung cancer returned after your first chemotherapy?
  3. Did you have at least 2 cycles of your first treatment, and your cancer progressed more than 30 days later?
  4. Are you generally in good health with no major heart problems or active infections?
  5. Do you have a tumour that doctors can measure to track treatment progress?
Answer every question to see your result.

What does participation involve?

If you decide to participate in this study, you will be randomly assigned to one of two treatment groups: either receiving the new medicine, Ris-Rez, or the standard treatment, topotecan. Both treatments will involve regular visits to the clinic for your medicine, close monitoring by the study team, and various tests like blood tests and scans to check your health and how the treatment is working. The specific schedule of visits and tests will be explained in detail by the study team.

The total duration of your participation will depend on how you respond to the treatment and your overall health. You will continue to receive treatment for as long as it is helping you and you are tolerating it well. Even after you stop treatment, there will be follow-up appointments to track your health and long-term outcomes for a certain period. The study team will provide all the necessary information about what to expect, including the frequency of visits and how long you might be involved.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new medicine (Ris-Rez) before it's widely available, which might be more effective than standard treatment. You'll also receive very close medical attention and monitoring. However, there are also potential risks; both Ris-Rez and topotecan can cause side effects, some of which could be serious. The study aims to understand these side effects better. You will be fully informed about all known and potential risks before you decide to join. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (120)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • GSK Investigational Site
    Verified postcode
    Mar del Plata, Argentina· Recruiting
  • GSK Investigational Site
    Verified postcode
    Buenos Aires, Argentina· Recruiting
  • GSK Investigational Site
    Unverified
    Ciudad Autonoma de Buenos Aire, Argentina· Recruiting
  • GSK Investigational Site
    Unverified
    Ciudad Autonoma de Buenos Aire, Argentina· Recruiting
  • GSK Investigational Site
    Verified postcode
    Rosario, Argentina· Recruiting
  • GSK Investigational Site
    Verified postcode
    Vicente López, Argentina· Recruiting
  • GSK Investigational Site
    Verified postcode
    Blacktown, Australia· Recruiting
  • GSK Investigational Site
    Verified postcode
    St Leonards, Australia· Recruiting
  • GSK Investigational Site
    Verified postcode
    Nedlands, Australia· Recruiting
  • GSK Investigational Site
    Verified postcode
    Barretos, Brazil· Recruiting
  • GSK Investigational Site
    Unverified
    CuritibaPR, Brazil· Recruiting
  • GSK Investigational Site
    Verified postcode
    Florianópolis, Brazil· Recruiting

Common questions

What is small cell lung cancer?

Small cell lung cancer is a type of lung cancer that tends to grow and spread quickly. This study focuses on cases where the cancer has come back after initial treatment.

What is Ris-Rez?

Ris-Rez is a new experimental medicine that targets specific proteins on cancer cells to help stop their growth and spread. It's being tested to see if it's better than current treatments.

What is topotecan?

Topotecan is a standard chemotherapy medicine commonly used to treat small cell lung cancer, especially when it has returned.

Will I know which treatment I'm receiving?

No, you won't know if you're getting Ris-Rez or topotecan. This is done by chance, like flipping a coin, to ensure the study results are fair and unbiased.

What are the main goals of this study?

The study aims to see if Ris-Rez can shrink tumours, help people live longer, and understand its safety compared to topotecan for relapsed small cell lung cancer.

How to find out more

US GSK Clinical Trials Call Center

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 "A Study of GSK5764227 in Participants With Relapsed Small Ce…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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