Active not recruitingPHASE3INTERVENTIONAL

Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46)

This research study is for people with a type of advanced lung cancer called non-small cell lung cancer (NSCLC), where their cancer cells show high levels of a specific protein called PD-L1. The study wants to find out if combining two treatments, pembrolizumab and sacituzumab govitecan, is more effective than pembrolizumab alone. Researchers will compare how well each treatment stops the cancer from growing and how it affects how long people live. This is a Phase 3 study, meaning it's a large trial aiming to confirm if the new combination is better than the current standard approach for this specific group of patients.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

614

Start

06 Feb 2023

Estimated completion

23 Aug 2028

Carcinoma, Non-Small-Cell Lung

What is this study about?

This study is a clinical trial, which means it's a research study that involves volunteers. The aim is to find better ways to treat a specific type of advanced lung cancer called non-small cell lung cancer. In this particular study, doctors are focusing on patients whose cancer cells have a high amount of a specific marker called PD-L1.

The trial is comparing two treatment approaches. One approach uses a drug called pembrolizumab on its own. This drug is already used in cancer treatment and works by helping your body's immune system fight the cancer. The other approach combines pembrolizumab with a new drug called sacituzumab govitecan. Researchers want to see if adding this second drug makes the treatment more effective than just pembrolizumab alone.

The main things the study will measure are progression-free survival (how long someone lives without their cancer getting worse) and overall survival (how long someone lives after starting treatment). By comparing these outcomes between the two treatment groups, doctors hope to understand if the combination therapy offers a significant improvement for people with this specific type of lung cancer.

Key takeaways

This study compares two treatments for advanced non-small cell lung cancer with high PD-L1 levels.
It aims to see if combining pembrolizumab with sacituzumab govitecan is better than pembrolizumab alone.
The main goals are to improve how long people live without their cancer getting worse and overall survival.
Participation involves regular clinic visits, treatments, blood tests, and scans.
It's a large Phase 3 trial, crucial for determining future lung cancer treatments.

Who may be eligible?

To join this study, you must be 18 years or older and have non-small cell lung cancer that has spread (metastatic). Your doctors must have confirmed that your cancer doesn't have certain genetic changes (like EGFR, ALK-1, or ROS-1) that would mean a different type of treatment is recommended first. Importantly, your cancer cells must show a high level (at least 50%) of a specific protein called PD-L1 when tested.

There are also some reasons why you might not be able to join. For example, if you've had another type of cancer recently (unless it was completely cured a long time ago) or if you've already received chemotherapy, targeted therapy, or certain other immune treatments for your widespread lung cancer. You also can't have had specific types of drugs called Topoisomerase 1 inhibitors or Trop-2 targeted therapy before.

Other reasons for not joining include having received certain types of radiotherapy or live vaccines recently, or if you've had certain serious heart problems in the past six months. The research team will review all your medical information carefully to see if this study is right for you.

Quick self-check

Do I have metastatic non-small cell lung cancer?
Has my cancer been tested for PD-L1, and is it 50% or higher?
Have I avoided recent chemotherapy or other specific immune therapies for my widespread lung cancer?
Do I have any serious heart conditions or other cancers that might exclude me?
Am I at least 18 years old?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will receive one of the two treatment options: either pembrolizumab on its own, or pembrolizumab combined with sacituzumab govitecan. The treatments are given as infusions (into a vein).

You will have regular visits to the clinic for your treatments, blood tests, and scans to check how the cancer is responding. These visits will be more frequent at the beginning of the study and may become less frequent over time. The total duration of your participation could vary, depending on how your cancer responds to the treatment. You will also have follow-up appointments after your treatment finishes to monitor your health.

Throughout the study, the research team will closely monitor your health and any side effects you might experience. They will provide you with all the necessary information and support.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to new treatments before they are widely available, and close medical monitoring. However, it's also important to understand there are potential risks, as new treatments can have side effects that aren't fully known, or might not work for everyone. The specific risks and benefits will be fully explained by the study team, and you will have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (180)

Infirmary Cancer Care ( Site 0418)
Mobile, United States
Profound Research LLC ( Site 0444)
Oceanside, United States
Clermont Oncology Center ( Site 0421)
Clermont, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0417)
Miami, United States
Mid Florida Hematology and Oncology Center ( Site 0416)
Orange City, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0407)
Marietta, United States
Our Lady of the Lake RMC ( Site 0424)
Baton Rouge, United States
Henry Ford Hospital ( Site 0412)
Detroit, United States
Profound Research LLC ( Site 0440)
Farmington Hills, United States
Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0425)
Minneapolis, United States
Basil Clinical ( Site 0441)
Inwood, United States
White Plains Hospital-Center for Cancer Care ( Site 0403)
White Plains, United States

+168 more sites — see the official record for the full list.

Common questions

What is metastatic non-small cell lung cancer?

This is a type of lung cancer where the cancer cells have spread from the lung to other parts of the body.

What is PD-L1?

PD-L1 is a protein found on the surface of some cancer cells. High levels of PD-L1 can help doctors decide which treatments might work best.

What is a Phase 3 study?

A Phase 3 study is a large research trial that compares a new treatment to an existing one to see if it's better or safer, before it can be widely approved.

Will I know which treatment I'm getting?

In some studies, you might not know which specific treatment you are receiving (this is called 'blinded'), to ensure the results are unbiased. The study team will explain how this works.

What if my cancer starts to get worse?

Your condition will be closely monitored. If your cancer worsens, the study doctors will discuss the next steps for your care, which may include stopping the study treatment.