Active not recruitingPHASE3INTERVENTIONAL

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

This important study is for adults with a specific type of lung cancer called non-small cell lung cancer (NSCLC). This cancer also has a particular genetic change, known as an EGFR mutation. Participants in this study would have already tried other treatments for this type of lung cancer, called EGFR tyrosine kinase inhibitors, and their cancer has continued to grow. The main goal of the study is to see if a newer drug called sacituzumab tirumotecan works better at helping people live longer compared to a common chemotherapy treatment (pemetrexed and carboplatin). By comparing these treatments, researchers hope to find new and more effective ways to treat this specific type of lung cancer for patients in the future.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

520

Start

11 Jun 2024

Estimated completion

14 Jun 2030

Non-small Cell Lung Cancer (NSCLC)

What is this study about?

This study is a clinical trial, which means it's a carefully designed research study involving people. It's focused on a type of lung cancer called non-small cell lung cancer (NSCLC). Specifically, it's for people whose NSCLC has certain changes in its genetic material, known as an EGFR mutation, and whose cancer has continued to grow even after trying other targeted treatments called EGFR tyrosine kinase inhibitors.

The main aim of this study is to compare a new experimental treatment with a standard treatment. The experimental treatment is a drug called sacituzumab tirumotecan. It's being compared to a combination of two chemotherapy drugs, pemetrexed and carboplatin, which is a common treatment for this type of cancer. Researchers want to find out if the new drug can help people live longer than the standard chemotherapy.

Participants will be split randomly into two groups, like flipping a coin. One group will receive the new drug, and the other will receive the chemotherapy combination. Doctors will then closely watch how everyone responds to their treatment. The results of this study could help doctors understand if sacituzumab tirumotecan could become a new, better option for treating people with this specific type of lung cancer.

Key takeaways

This study compares a new drug to standard chemotherapy for a specific lung cancer.
It's for people whose non-small cell lung cancer (EGFR-mutated) has progressed on prior treatments.
Participants will be randomly assigned to one of two treatment groups.
The main goal is to see if the new drug improves survival more than standard treatment.
You will receive treatments and regular check-ups until your doctor decides to stop the treatment.
Additional medications will be provided to help manage potential side effects.

Who may be eligible?

This study is looking for adults (18 years or older) who have been diagnosed with a type of lung cancer called non-small cell lung cancer. Specifically, it must be the 'non-squamous' type, and have a particular genetic change (EGFR mutation). You must also have already tried other treatments for this lung cancer, and your cancer has continued to grow.

There are also some important health conditions that might prevent you from joining. For example, if you have certain other serious medical conditions like uncontrolled heart problems, severe nerve damage, or a recent history of other cancers. You also can't have certain ongoing infections or active brain tumours. The study team will review your full medical history to see if it's safe and appropriate for you to take part.

If you've had previous treatments for cancer, any side effects from those treatments should have mostly cleared up. If you have dormant hepatitis B or C, or controlled HIV, you might still be able to join, but you’ll need to meet specific medical requirements, like having your viral levels under control.

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.

Are you 18 years or older?
Do you have non-small cell lung cancer (non-squamous type) with an EGFR mutation?
Has your lung cancer worsened after trying previous EGFR inhibitor treatments?
Are you generally well enough to participate in a clinical study?
Do you have any severe medical conditions like uncontrolled heart problems or active brain tumours?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be randomly assigned to receive either the new drug (sacituzumab tirumotecan) or the standard chemotherapy (pemetrexed plus carboplatin). This is like drawing names from a hat – you won't get to choose which treatment you receive. You will continue to have your assigned treatment for as long as it is helping you and you are not experiencing severe side effects. Regular visits to the hospital will be needed for your treatments and to have checks and tests to see how you are responding and to monitor for any side effects. These could include blood tests, scans, and physical examinations. You will also be given some medications to help manage possible side effects, such as anti-allergy drugs and steroids, alongside your main treatment. The study will continue until doctors decide it's no longer beneficial for you to receive the study drug, or if you choose to stop participating. The total duration of your participation will vary depending on your individual response to treatment.

Potential risks and benefits

Taking part in a clinical trial can offer potential benefits, as you might receive a new treatment that isn't yet widely available and that could be more effective than existing options. However, there are also potential risks involved. All medications can have side effects, and some may be serious. The study team will monitor you closely for any unwanted effects. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (156)

Kaiser Permanente - Oakland ( Site 0054)
Verified postcode
Oakland, United States
Kaiser Permanente - Roseville ( Site 0055)
Verified postcode
Roseville, United States
Kaiser Permanente - San Francisco ( Site 0056)
Verified postcode
San Francisco, United States
Kaiser Permanente - Santa Clara ( Site 0057)
Verified postcode
Santa Clara, United States
Kaiser Permanente-Kaiser Permanente ( Site 0036)
Verified postcode
Vallejo, United States
Kaiser Permanente - Walnut Creek ( Site 0058)
Verified postcode
Walnut Creek, 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
University of Michigan ( Site 0009)
Verified postcode
Ann Arbor, United States
Cox Medical Center North - Cox Medical Center/ Hematology/Medical Oncology ( Site 0051)
Verified postcode
Springfield, United States
Astera Cancer Care ( Site 0032)
Verified postcode
East Brunswick, United States
Stony Brook University-Cancer Center ( Site 0038)
Verified postcode
Stony Brook, United States

Common questions

What is EGFR-mutated lung cancer?

It's a type of non-small cell lung cancer where the cancer cells have a specific genetic change (mutation) in the Epidermal Growth Factor Receptor (EGFR) gene.

What are EGFR tyrosine kinase inhibitors (TKIs)?

These are targeted drugs that block the activity of the EGFR protein, which can help slow down the growth of EGFR-mutated lung cancer cells.

Is sacituzumab tirumotecan a chemotherapy?

Sacituzumab tirumotecan is a type of targeted therapy, not a traditional chemotherapy. It's designed to specifically target cancer cells.

What does 'randomized 1:1' mean?

It means you have an equal 50/50 chance of being assigned to either the new drug group or the standard chemotherapy group, like flipping a coin.

How long will I be in the study?

You will receive treatment for as long as it is working for you and is safe, and you will be monitored regularly throughout that time. The total length of your participation will vary from person to person.