All studies
RecruitingPHASE3INTERVENTIONAL

Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)

This research trial is investigating a new way to treat non-small cell lung cancer that has spread, what doctors call metastatic NSCLC. The main goal is to compare two different treatment approaches: one group will receive a combination of two drugs, sacituzumab tirumotecan and pembrolizumab, while another group will receive pembrolizumab by itself. The study aims to find out if taking the two drugs together helps people live longer than with pembrolizumab alone. Participants who don't improve on the initial treatment might also be able to receive more pembrolizumab later on. This is a Phase 3 study, meaning it's a critical step in testing if this new combination could become a standard treatment.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
614
Start
15 Dec 2023
Estimated completion
27 May 2030

What is this study about?

This study is focusing on a type of lung cancer known as non-small cell lung cancer (NSCLC) that has spread to other parts of the body, which doctors call metastatic cancer. When cancer has spread, it means it's more advanced and can be harder to treat effectively. The researchers are particularly interested in patients whose cancer cells show a high level of a specific protein called PD-L1 (over 50%). This is important because pembrolizumab, one of the drugs being tested, works by targeting this protein to help your body's immune system fight the cancer.

The main purpose of this study is to see if combining a newer drug, sacituzumab tirumotecan, with pembrolizumab is more effective than pembrolizumab used alone. They want to find out if this combination helps people live longer. Pembrolizumab is a type of immunotherapy that helps your own immune system recognise and attack cancer cells. Sacituzumab tirumotecan is a different kind of drug that combines an antibody with a chemotherapy drug, aiming to deliver the chemotherapy directly to cancer cells. By combining these two treatments, the researchers hope to see an improved outcome for patients.

This is a Phase 3 trial, which means it's usually the final step before a new treatment might become widely available. It involves a larger group of people and directly compares the new treatment combination to the current standard treatment (pembrolizumab alone in this case). The results of this study will help doctors understand the best way to treat this specific type of advanced lung cancer.

Key takeaways

  • The study is for advanced non-small cell lung cancer (NSCLC) with high PD-L1.
  • It compares two drugs (a combination) versus one drug (pembrolizumab) to see if it helps people live longer.
  • This is a Phase 3 study, a key step in testing new treatments.
  • Participants will have regular visits, treatments, and health checks.
  • You can stop participating at any time.
  • The study aims to improve treatment options for this cancer type.

Who may be eligible?

To be part of this study, you would need to have non-small cell lung cancer that has spread. Your doctors must have confirmed that other specific treatments, like those for EGFR, ALK, or ROS1 gene changes, are not suitable for you first. Crucially, your cancer cells must show a high level of a protein called PD-L1 (at least 50%), which will be checked with a special test on a sample of your tumour.

You also need to be generally well enough to participate, meaning you can carry out most of your normal daily activities. You would need to be expected to live for at least three more months, and if you have HIV, it must be well-managed with your current medication. People with small cell lung cancer or mixed tumours containing small cell elements generally cannot join.

There are also some conditions that would prevent you from taking part. For example, if you have severe nerve damage in your hands or feet (peripheral neuropathy), certain serious eye conditions, or active inflamatory bowel disease. If you've had a recent serious heart or brain condition, or if you've already received other treatments for your metastatic lung cancer, including other immunotherapy drugs like anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, you would likely not be eligible. However, if you had these immunotherapies for an earlier, non-spread form of lung cancer more than a year ago, you might still qualify.

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 I have non-small cell lung cancer that has spread?
  2. Has my doctor confirmed that EGFR, ALK, or ROS1 targeted treatments are not right for me?
  3. Has my cancer been tested and shown high levels of PD-L1 (50% or more)?
  4. Am I generally well enough to do most daily activities?
  5. Have I avoided any other cancer treatments for my metastatic lung cancer?
  6. Do I have severe nerve damage, serious eye issues, or active inflammatory bowel disease?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be assigned to one of two groups: one receiving the combination of sacituzumab tirumotecan and pembrolizumab, and the other receiving pembrolizumab on its own. You will have regular visits to the hospital for your treatments, which are usually given through a drip (intravenously).

Throughout the study, you'll have various tests, including blood samples, scans, and physical examinations, to monitor your health and how the treatment is working. Doctors will carefully track any side effects you might experience. If your cancer appears to worsen after the initial treatment course, some participants may be offered additional cycles of pembrolizumab alone.

There will be regular follow-up appointments even after your main treatment period ends, to continue monitoring your health over time. The total duration of your participation in the study, including follow-up, could extend over several months or even years, depending on how you respond to treatment.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to new treatments that aren't yet widely available, and close monitoring by a specialist medical team. While the aim of this study is to find a more effective treatment, there's no guarantee that it will improve your condition. There are also potential risks involved, as all medications can have side effects, and some may be serious. The study team will closely monitor you and manage any side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (219)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Mayo Clinic in Arizona - Phoenix ( Site 0147)
    Verified postcode
    Phoenix, United States· Recruiting
  • Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0130)
    Verified postcode
    Burbank, United States· Recruiting
  • Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0132)
    Verified postcode
    Grand Junction, United States· Recruiting
  • Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0133)
    Verified postcode
    Jacksonville, United States· Recruiting
  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0106)
    Verified postcode
    Marietta, United States· Completed
  • The University of Louisville, James Graham Brown Cancer Center ( Site 0121)
    Verified postcode
    Louisville, United States· Recruiting
  • New England Cancer Specialists ( Site 0143)
    Verified postcode
    Westbrook, United States· Recruiting
  • University of Massachusetts Chan Medical School-Division of Hematology/Oncology ( Site 0144)
    Verified postcode
    Worcester, United States· Completed
  • Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0115)
    Verified postcode
    Minneapolis, United States· Recruiting
  • Mayo Clinic - Rochester ( Site 0148)
    Verified postcode
    Rochester, United States· Recruiting
  • Hattiesburg Clinic Hematology/Oncology ( Site 0104)
    Verified postcode
    Hattiesburg, United States· Recruiting
  • Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0134)
    Verified postcode
    Reno, United States· Recruiting

Common questions

What is non-small cell lung cancer?

It's the most common type of lung cancer, and it's called 'non-small cell' because of how the cancer cells look under a microscope.

What is PD-L1?

PD-L1 is a protein found on cancer cells that can 'switch off' your body's immune cells. Treatments like pembrolizumab target it to help your immune system fight the cancer.

What are pembrolizumab and sacituzumab tirumotecan?

Pembrolizumab is an immunotherapy that helps your immune system fight cancer. Sacituzumab tirumotecan is a treatment that delivers a chemotherapy drug directly to cancer cells.

What does 'metastatic' mean?

Metastatic means the cancer has spread from where it started in the lung to other parts of the body.

Why compare two drugs to one?

Researchers want to see if combining the new drug (sacituzumab tirumotecan) with an existing one (pembrolizumab) works better than the existing drug on its own for this type of lung cancer.

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 "Sacituzumab Tirumotecan (MK-2870) in Combination With Pembro…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.