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RecruitingPHASE3INTERVENTIONAL

Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]

This study is for people with advanced squamous non-small cell lung cancer. It explores whether adding a new medication called sacituzumab tirumotecan (sac-TMT) to an existing treatment plan can improve outcomes. Initially, everyone receives a combination of Pembrolizumab, Carboplatin, and either Paclitaxel or Nab-paclitaxel for a few months. After this, participants are split into two groups by chance: one group continues with Pembrolizumab alone, while the other group receives Pembrolizumab plus sac-TMT. The main goal is to see if taking sac-TMT alongside Pembrolizumab helps people live longer compared to taking Pembrolizumab alone. It's a 'Phase 3' study, which means it's a larger trial comparing a new approach to standard care.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
851
Start
10 Jun 2024
Estimated completion
12 Feb 2031

What is this study about?

This research study is looking for better ways to treat a specific type of lung cancer called metastatic squamous non-small cell lung cancer. 'Metastatic' means the cancer has spread to other parts of the body. The study aims to see if adding a new drug, called sacituzumab tirumotecan (sac-TMT), to a standard treatment plan can help people live longer.

The study begins with a starting treatment phase. For about 12 weeks, all participants will receive a combination of three medicines: Pembrolizumab, Carboplatin, and either Paclitaxel or Nab-paclitaxel. These are given by drip (IV infusion).

After these initial 12 weeks, if your cancer hasn't worsened, you'll be randomly assigned to one of two groups. One group will continue to receive Pembrolizumab on its own (the current standard approach). The other group will receive Pembrolizumab plus the new drug, sac-TMT. By comparing these two groups, researchers hope to find out if adding sac-TMT is more effective at controlling the cancer and improving overall survival.

Key takeaways

  • The study tests a new drug, sac-TMT, for advanced squamous lung cancer.
  • It combines existing treatments with the new drug.
  • The main aim is to see if the new combination helps people live longer.
  • Participation involves an initial treatment phase, followed by random assignment to one of two groups.
  • Regular hospital visits, tests, and scans are part of the study.
  • It's a Phase 3 study, meaning it compares a new approach against standard care.

Who may be eligible?

This study is specifically for adults aged 18 or older who have been diagnosed with squamous non-small cell lung cancer that has spread (stage IV).

To be considered, your doctors must be able to measure your cancer, and you should generally feel well enough to take part, with a good quality of life expected for at least three months. You'll also need to provide a sample of your cancer tissue. The study has specific health requirements, for example, your organs like your kidneys and liver need to be working properly.

If you have conditions like HIV, Hepatitis B, or Hepatitis C, you might still be able to join if these conditions are well-managed with treatment. Also, any side effects from previous cancer treatments should have mostly improved before you start the study. For those continuing into the second part of the study, your cancer should not have grown during the initial treatment phase.

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. Do you have squamous non-small cell lung cancer that has spread?
  2. Are you 18 years old or older?
  3. Are you generally well enough to take part, with a good outlook for at least 3 months?
  4. Are your organs, like your liver and kidneys, working properly?
  5. Have any side effects from previous cancer treatments mostly gone away?
  6. Are you willing to provide a sample of your cancer tissue?
Answer every question to see your result.

What does participation involve?

Taking part in this study involves a few stages. First, everyone will receive an initial treatment for about 12 weeks. This involves an IV drip of Pembrolizumab, Carboplatin, and either Paclitaxel or Nab-paclitaxel, given every three weeks. During this time, you will have regular clinic visits, blood tests, and scans to check on your health and how the treatment is working. You'll also need to provide a sample of your cancer tissue.

After these first 12 weeks, if your cancer hasn't progressed, you will then be randomly assigned to one of two treatment groups. One group will continue with Pembrolizumab alone, and the other will receive Pembrolizumab plus sac-TMT. Both drugs are given by IV drip. You’ll have ongoing visits, tests, and scans to monitor your health and the treatment's effect. The total duration of your participation will depend on how you respond to the treatment and for how long the treatment benefits you.

Potential risks and benefits

Participating in this study might offer potential benefits, such as access to a new experimental drug (sac-TMT) that could be more effective than current standard treatments. However, there are no guarantees, and it's also possible that the new treatment may not work for you or could have side effects. All medical treatments carry potential risks, such as side effects from the medications, which your care team will discuss with you in detail. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (212)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • CARTI Cancer Center ( Site 0006)
    Verified postcode
    Little Rock, United States· Recruiting
  • Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0122)
    Verified postcode
    Burbank, United States· Recruiting
  • Sharp Memorial Hospital ( Site 9544)
    Verified postcode
    San Diego, United States· Recruiting
  • Intermountain Health Cancer Center Lutheran Hospital ( Site 0119)
    Verified postcode
    Golden, United States· Recruiting
  • Intermountain Health St. Mary's Regional Hospital ( Site 0116)
    Verified postcode
    Grand Junction, United States· Recruiting
  • Washington Hospital Center ( Site 0037)
    Verified postcode
    Washington D.C., United States· Recruiting
  • Mid Florida Hematology and Oncology Center ( Site 0109)
    Verified postcode
    Orange City, United States· Completed
  • Centricity Research Columbus Cancer Center ( Site 0111)
    Verified postcode
    Columbus, United States· Completed
  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0001)
    Verified postcode
    Marietta, United States· Completed
  • Southeastern Regional Medical Center ( Site 0004)
    Verified postcode
    Newnan, United States· Completed
  • University of Chicago Medical Center ( Site 0145)
    Verified postcode
    Chicago, United States· Recruiting
  • Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0146)
    Verified postcode
    Minneapolis, United States· Recruiting

Common questions

What type of cancer is this study for?

This study is for people with advanced squamous non-small cell lung cancer that has spread to other parts of the body.

What are the main goals of this study?

The main goal is to see if adding a new drug, sac-TMT, to a standard treatment helps people with this type of lung cancer live longer.

Will I know which treatment I'm getting?

After an initial treatment period, you will be randomly assigned to one of two groups. You will know if you are receiving Pembrolizumab alone or Pembrolizumab plus sac-TMT.

How long will I be in the study?

The length of your participation will depend on how well the treatment works for you and as long as you continue to benefit from it.

What happens if I want to stop participating?

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

How to find out more

Toll Free Number

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 "Pembrolizumab With or Without Maintenance Sacituzumab Tirumo…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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