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Active not recruitingPHASE3INTERVENTIONAL

Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)

This research study is looking at a new treatment called Sacituzumab Tirumotecan for advanced non-small cell lung cancer (NSCLC). This is a type of lung cancer that has spread or can't be removed, and has specific genetic changes (like EGFR, ALK, or others). Patients in this study have already received some previous treatments. The study aims to see if Sacituzumab Tirumotecan is better than standard chemotherapy (docetaxel or pemetrexed) at two main things: first, keeping the cancer from growing for a longer time, and second, helping people live longer. It’s a comparison to find out if this new medicine could be a more effective option for people with this specific type of lung cancer.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
556
Start
12 Nov 2023
Estimated completion
11 Mar 2030

What is this study about?

This study is called MK-2870-004 and it's trying to find a better treatment for a type of lung cancer called non-small cell lung cancer (NSCLC). Specifically, it's for people whose cancer has spread or is advanced, and has some particular genetic changes. These changes can include EGFR mutations, or others like ALK, ROS1, or BRAF mutations. These genetic changes are like tiny switches in the cancer cells that make them grow differently.

Patients taking part in this study have already had some treatment for their lung cancer. The study will compare a new medicine called Sacituzumab Tirumotecan with standard chemotherapy medicines, which are usually docetaxel or pemetrexed. Researchers want to know if Sacituzumab Tirumotecan can help keep the cancer from growing for a longer time, and if it can help people live longer compared to standard chemotherapy.

By comparing these treatments, doctors hope to learn if Sacituzumab Tirumotecan could become a new, effective way to treat patients with this specific kind of lung cancer that has already been treated. This is a "Phase 3" study, which means it’s a big study involving many people, and it’s a crucial step before a new medicine can be considered for wider use.

Key takeaways

  • This study compares a new medicine to standard chemotherapy for advanced lung cancer.
  • It's for specific types of non-small cell lung cancer with particular genetic changes.
  • Participants have already received previous treatments for their cancer.
  • The main goals are to see if the new medicine helps people live longer and keeps cancer from growing longer.
  • You will receive either the new drug or standard chemotherapy, decided by chance.

Who may be eligible?

To join this study, your lung cancer must be a specific type called 'non-small cell lung cancer' (NSCLC), and it needs to be an advanced stage or have spread to other parts of your body. Importantly, your cancer must also have certain genetic changes, such as EGFR mutations or others like ALK, ROS1, or BRAF.

You must have already received some previous treatments for your lung cancer, and your cancer needs to have shown signs of growing again after these treatments. Also, doctors need to be able to measure your cancer on scans. There are also health requirements, like good overall health, and for some conditions like Hepatitis B or HIV, they must be well-managed.

People whose cancer is primarily a different type of lung cancer (called squamous cell) or has small cell elements, or who have certain other medical conditions like severe heart problems, nerve damage (neuropathy), or specific eye conditions, would not be able to take part.

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 advanced or metastatic non-small cell lung cancer?
  2. Has your cancer been tested and found to have specific genetic changes (like EGFR, ALK, or others)?
  3. Have you already had at least one line of treatment for your lung cancer, and it has progressed?
  4. Are you generally in good health, despite your cancer?
  5. Do you have a clear understanding of the study and are willing to commit to regular hospital visits?
Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the hospital or clinic. You would receive either the new study drug, Sacituzumab Tirumotecan, or one of the standard chemotherapy medicines (docetaxel or pemetrexed), given through a drip into your arm.

Throughout the study, you would undergo various tests and checks, including blood tests, scans (like CT or MRI) to see how your cancer is responding, and physical examinations. These assessments help the doctors monitor your health and the effectiveness of the treatment. The total duration of your participation would depend on how your cancer responds to the treatment and your general health, and would continue as long as the treatment is benefiting you and you are tolerating it well. There will also be follow-up appointments after your treatment ends.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from receiving a new treatment that could be more effective than current options, or from the close monitoring you'd receive. However, treatments can have side effects, and it's possible the study drug might not work for you, or could cause unpleasant or serious side effects. You will be told about all known side effects before you decide to join. It's very important to remember that you are free to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (194)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • UCLA Hematology/Oncology - Santa Monica ( Site 0023)
    Verified postcode
    Los Angeles, United States
  • Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0001)
    Verified postcode
    Jacksonville, United States
  • Mid Florida Hematology and Oncology Center ( Site 0005)
    Verified postcode
    Orange City, United States
  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0003)
    Verified postcode
    Marietta, United States
  • Karmanos Cancer Institute ( Site 0018)
    Verified postcode
    Detroit, United States
  • Mayo Clinic in Rochester, Minnesota-Mayo Clinic Comprehensive Cancer Center ( Site 0027)
    Verified postcode
    Rochester, United States
  • Hattiesburg Clinic Hematology/Oncology ( Site 0010)
    Verified postcode
    Hattiesburg, United States
  • University Of Nebraska Medical Center ( Site 0011)
    Verified postcode
    Omaha, United States
  • Englewood Hospital and Medical Center ( Site 0033)
    Verified postcode
    Englewood, United States
  • Atlantic Health System Morristown Medical Center ( Site 0031)
    Verified postcode
    Morristown, United States
  • Capital Health Medical Center - Hopewell ( Site 0006)
    Verified postcode
    Pennington, United States
  • University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0015)
    Verified postcode
    Cincinnati, United States

Common questions

What is non-small cell lung cancer (NSCLC)?

It's the most common type of lung cancer. This study is for a specific kind of NSCLC that has certain genetic changes.

What are 'genetic changes' in cancer?

These are tiny changes in the cancer cells' DNA that can affect how they grow and respond to treatments. Doctors test for these to choose the best treatment.

What does 'previously treated' mean?

It means you have already received at least one course of treatment for your lung cancer, and it has started to grow again.

Will I definitely get the new drug?

Because this is a comparison study, you might receive the new medicine or standard chemotherapy. Which one you get is decided by chance.

How long will I be in the study?

You'll stay in the study as long as the treatment is helping you and you're feeling well enough to continue. There will also be follow-up after treatment.

How to find out more

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

Discussion

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