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RecruitingPHASE3INTERVENTIONAL

This is a Study to Learn About How the Combination of the Study Medicines Sigvotatug Vedotin Plus Pembrolizumab Works in People With Non-small Cell Lung Cancer With High Levels of PD-L1.

This study is investigating a new treatment approach for non-small cell lung cancer which has high levels of a specific protein called PD-L1. We're comparing a new combination of two medicines, Sigvotatug Vedotin and pembrolizumab, against pembrolizumab by itself. Pembrolizumab is a commonly used immunotherapy. Researchers want to find out if adding Sigvotatug Vedotin to pembrolizumab can make the treatment more effective for patients with this type of lung cancer that has spread or can't be removed by surgery. Participants will receive their medication directly into a vein at a clinic, with researchers carefully monitoring their progress throughout the study. This helps us understand if the new combination is a promising option.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Pfizer
Enrolment target
714
Start
23 Jul 2025
Estimated completion
01 Mar 2029

What is this study about?

This research study is about finding better ways to treat a type of lung cancer called non-small cell lung cancer, specifically when it has high levels of a protein known as PD-L1. Think of PD-L1 as a kind of 'brake' on your body's immune system. Cancer cells sometimes use this brake to hide from your immune cells, allowing the cancer to grow.

The study is testing a new combination of two medicines: Sigvotatug Vedotin and pembrolizumab. Pembrolizumab is already a common treatment for this type of lung cancer, and it works by releasing the immune system's brakes. Researchers want to see if adding Sigvotatug Vedotin to pembrolizumab will improve how well the treatment works compared to just receiving pembrolizumab on its own.

By comparing these treatments, doctors hope to learn if this new combination could offer a more effective option for patients with non-small cell lung cancer where the cancer has either spread (Stage 4) or is advanced and cannot be removed by surgery or treated by a combination of chemotherapy and radiotherapy (Stage 3B or 3C). Every step of the study is carefully controlled and monitored. The goal is to improve future treatments for this condition.

Key takeaways

  • Tests a new combination of treatments for non-small cell lung cancer.
  • Specifically for cancer with high levels of the PD-L1 protein.
  • Compares the new combination to pembrolizumab alone.
  • Study medicines are given through IV infusions at a clinic.
  • Close monitoring by the study team throughout your participation.
  • You can stop participating at any time.

Who may be eligible?

To join this study, you need to have been diagnosed with non-small cell lung cancer that is either advanced (Stage 3B or 3C and can't be treated with surgery or combined chemo/radiotherapy) or has spread to other parts of your body (Stage 4). A key requirement is that your cancer cells must show high levels of the PD-L1 protein, meaning it's found in 50% or more of your cancer cells. Your cancer also needs to be easily measured, and you should be generally well enough to manage the treatment.

There are also some reasons why you might not be able to join. For example, if you have other serious health conditions, or if you've been diagnosed with another type of cancer in the last three years. If you've had severe lung problems in the past, or if you're allergic to any of the study medicines, you wouldn't be able to take part. The study also needs to make sure your specific type of non-small cell lung cancer doesn't have certain other genetic changes (like EGFR, ALK, or ROS1) that would usually be treated differently.

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 is advanced (Stage 3B/3C and not treatable with surgery/chemoradiation) or has spread (Stage 4)?
  2. Have tests shown that my cancer has high levels of the PD-L1 protein (50% or more)?
  3. Am I well enough to take part in a clinical trial?
  4. Do I have other serious health problems or a recent history of another cancer that might exclude me?
  5. Am I allergic to any of the medicines being studied?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will visit the clinic regularly. All participants will receive pembrolizumab, a study medicine, through an IV drip (directly into a vein) every 6 weeks. Half of the participants will also receive a second study medicine, Sigvotatug Vedotin, through an IV drip every 2 weeks.

You might receive pembrolizumab for up to about two years. If you're also taking Sigvotatug Vedotin, you can continue this as long as your lung cancer is responding to the treatment. During your clinic visits, the study team will closely monitor your health and how you're responding to the treatment. They will do regular checks and tests to see how you are doing.

Potential risks and benefits

Taking part in a study like this could potentially offer you access to a new treatment combination that might work better than standard care for your type of lung cancer. However, there's no guarantee of benefit, and the medicines, especially new combinations, can cause side effects. Possible risks include common side effects associated with cancer treatments, such as tiredness, feeling sick, or effects on your immune system. The study team will carefully monitor you for 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 (329)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Providence St. Jude Medical Center Virginia K. Crosson Cancer Center and Infusion Center
    Verified postcode
    Fullerton, United States· Recruiting
  • Providence St. Jude Medical Center
    Verified postcode
    Fullerton, United States· Recruiting
  • St. Jude Heritage Medical Group - Fullerton Plaza Multi-Specialty Clinic (Pulmonary Function Test)
    Verified postcode
    Fullerton, United States· Recruiting
  • Intermountain Health Cancer Center Lutheran Hospital
    Verified postcode
    Golden, United States· Recruiting
  • Cancer Centers of Colorado St. Mary's Regional Hospital
    Verified postcode
    Grand Junction, United States· Recruiting
  • Intermountain Health St. Mary's Regional Hospital
    Verified postcode
    Grand Junction, United States· Recruiting
  • Intermountain Health
    Verified postcode
    Grand Junction, United States· Recruiting
  • Intermountain Health Lutheran Hospital
    Verified postcode
    Wheat Ridge, United States· Recruiting
  • Washington DC Veterans Affairs Medical Center
    Verified postcode
    Washington D.C., United States· Recruiting
  • Mid Florida Hematology and Oncology Center
    Verified postcode
    Orange City, United States· Recruiting
  • BRCR Global
    Verified postcode
    Plantation, United States· Recruiting
  • Endeavor Health
    Verified postcode
    Elmhurst, United States· Recruiting

Common questions

What is PD-L1?

PD-L1 is a protein on cancer cells that acts like a 'brake' to stop your immune system from attacking the cancer. This study is for people whose cancer has a lot of this protein.

What are Sigvotatug Vedotin and pembrolizumab?

Pembrolizumab is a type of immunotherapy that helps your immune system fight cancer. Sigvotatug Vedotin is another study medicine that will be tested in combination with pembrolizumab.

How will I receive the treatments?

Both medicines are given directly into a vein (IV infusion) in the clinic. Pembrolizumab is given every 6 weeks, and Sigvotatug Vedotin (if you receive it) is given every 2 weeks.

How long will I be on the study treatment?

You might receive pembrolizumab for up to two years. If you receive Sigvotatug Vedotin, you can continue until your cancer no longer responds to the treatment.

Will I know which treatment I am getting?

In this type of study, participants are usually randomly assigned to one treatment group or another. The study team will explain how this works when they discuss the study with you.

How to find out more

Pfizer CT.gov Call Center

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 "This is a Study to Learn About How the Combination of the St…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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