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RecruitingPHASE3INTERVENTIONAL

Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer

This study is investigating a new medicine called sacituzumab govitecan (SG), also known as Trodelvy®, for people who have extensive stage small cell lung cancer (ES-SCLC) that has already been treated. We're comparing SG to the usual treatments doctors give, such as Topotecan or Amrubicin. The main aim is to find out if SG can help people live longer than these standard care options. This is a Phase 3 study, meaning it's a large trial to confirm the benefits of the new drug. By taking part, you could contribute to understanding new ways to treat this type of cancer.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Gilead Sciences
Enrolment target
695
Start
04 Apr 2025
Estimated completion
01 Oct 2029

What is this study about?

This study is about finding better treatments for a type of lung cancer called extensive stage small cell lung cancer (ES-SCLC). When cancer is 'extensive stage,' it means it has spread beyond the lung where it started. 'Small cell' refers to how the cancer cells look under a microscope. This type of lung cancer can be challenging to treat, especially if it has come back or grown after initial treatments.

Researchers want to see if a new medicine called sacituzumab govitecan (often shortened to SG, or known as Trodelvy®) can help people with this kind of cancer live longer. They are comparing SG to other standard treatments that doctors currently use for this condition, like Topotecan or Amrubicin. Essentially, they are trying to discover if SG is a more effective option than what’s currently available.

You might have already received some treatment for your lung cancer, and this study is for people whose cancer has progressed after that initial treatment. By taking part, you would be helping doctors and scientists learn more about this new medicine and potentially improve future treatments for people with extensive stage small cell lung cancer. It's an important step in finding new ways to fight this disease.

Key takeaways

  • This study is for adults with extensive stage small cell lung cancer that has been previously treated.
  • It compares a new medicine (sacituzumab govitecan) to standard existing treatments.
  • The main goal is to see if the new medicine helps people live longer.
  • You won't choose your treatment; it's decided randomly.
  • There will be regular hospital visits, tests, and closely monitored follow-up.
  • You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult, 18 years or older, and have a confirmed diagnosis of extensive stage small cell lung cancer. Your cancer must also have grown or spread after you've already had at least one round of chemotherapy that included specific platinum-based drugs. Doctors will also check that you are well enough to participate, for example, your daily activities aren't too limited by your health.

There are some reasons why you might not be able to join. For instance, if the time between your last chemotherapy and your cancer growing was very short (less than 30 days). Also, if you've already had certain other types of cancer treatment, such as irinotecan, topotecan, or lurbinectedin after your platinum-based chemotherapy, you wouldn't be able to take part. The study also needs to see clear signs of your cancer on scans like CT or MRI.

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 extensive stage small cell lung cancer?
  3. Has your cancer grown or progressed after at least one previous chemotherapy treatment including platinum-based drugs?
  4. Are you generally well enough to manage day-to-day activities with minimal help?
  5. Have you NOT received certain specific cancer medicines (like irinotecan, topotecan, or lurbinectedin) after your previous platinum chemotherapy?
  6. Do you have clear signs of cancer that can be seen on scans?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll either receive the new study drug, sacituzumab govitecan, or one of the standard treatments for your condition. You won't get to choose which treatment you receive; this is decided randomly, like flipping a coin. You'll have regular hospital visits, where doctors will give you your medication and conduct various tests. These tests might include blood tests, physical exams, and scans (like CT or MRI) to see how the treatment is working. The exact number of visits and tests will be explained to you by the study team.

Your health will be closely monitored throughout the study. After the main treatment period, you might still have follow-up visits or phone calls to check on your long-term health. The total time you'd be involved in the study can vary, depending on how your treatment progresses, but it will be thoroughly explained to you before you agree to participate.

Potential risks and benefits

Participating in any study has potential benefits and risks. A potential benefit of joining this study is that you might have access to a new treatment, sacituzumab govitecan, which may be more effective than current standard options. However, there's no guarantee the treatment will work for you, and your cancer might not improve. Potential risks include side effects from the study drug or standard treatments. These side effects can vary from mild to severe, and the study team will explain them in detail. It's very important to remember that joining is voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (210)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Genesis Cancer and Blood Institute
    Verified postcode
    Hot Springs, United States· Not yet recruiting
  • Los Angeles Cancer Network
    Verified postcode
    Anaheim, United States· Recruiting
  • Boca Raton Regional
    Verified postcode
    Miami, United States· Recruiting
  • Hope and Healing Cancer Services
    Verified postcode
    Hinsdale, United States· Recruiting
  • Southern Illinois University School of Medicine
    Verified postcode
    Springfield, United States· Recruiting
  • Springfield Clinic
    Verified postcode
    Springfield, United States· Recruiting
  • Parkview Research Center
    Verified postcode
    Fort Wayne, United States· Recruiting
  • IU Health Ball Memorial Hospital and Physicians - Cancer Center - Muncie
    Verified postcode
    Muncie, United States· Recruiting
  • Northwest Cancer Centers
    Verified postcode
    Dyer, United States· Recruiting
  • St. Claire Regional Medical Ce
    Verified postcode
    Morehead, United States· Recruiting
  • New Mexico Oncology Hematology Consultants, Ltd
    Verified postcode
    Albuquerque, United States· Recruiting
  • University Hospitals Seidman Cancer Center
    Verified postcode
    Sandusky, United States· Recruiting

Common questions

What is extensive stage small cell lung cancer?

It's a type of lung cancer where the cancer cells are small, and it has spread beyond the lung where it started.

What is sacituzumab govitecan?

It's a new medicine being tested in this study to see if it can help treat your type of lung cancer.

Will I definitely get the new drug?

No, you will be randomly assigned to either receive the new drug or one of the standard treatments. You won't get to choose.

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 usual medical care.

How long will I be in the study?

The length of time can vary for each person, but the study team will explain the expected duration before you join.

How to find out more

Gilead Clinical Study Information Cente

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 "Study of Sacituzumab Govitecan Versus Standard of Care in Pa…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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