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Study of Sigvotatug Vedotin and Pembrolizumab for Patients with Advanced Non-Small Cell Lung Cancer with High PD-L1 Levels

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of lung cancer known as non-small cell lung cancer (NSCLC). The study is investigating the effectiveness of a new treatment combination for patients with advanced stages of this cancer. The treatment being tested includes two medications: Sigvotatug vedotin and pembrolizumab. Sigvotatug vedotin is a special type of medication that targets cancer cells, while pembrolizumab is an existing treatment that helps the immune system fight cancer.

The purpose of the study is to see if the combination of Sigvotatug vedotin and pembrolizumab is better at treating NSCLC compared to using pembrolizumab alone. Participants in the study will be randomly assigned to receive either the combination treatment or pembrolizumab by itself. The study will monitor how long patients live and how long they remain free from cancer progression. The trial will also look at the safety of the treatments and any side effects that may occur.

Participants will receive the treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will take place over several months, with regular check-ups to monitor the participants' health and the effectiveness of the treatment. The trial aims to provide valuable information that could improve treatment options for people with advanced non-small cell lung cancer.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be assigned to one of two groups. One group will receive a combination of two medications: sigvotatug vedotin and pembrolizumab. The other group will receive only pembrolizumab.

    The purpose of this study is to compare the effectiveness of the combination treatment with the single medication treatment in people with a specific type of lung cancer.

  2. Step 2

    Treatment administration

    If you are in the combination treatment group, you will receive sigvotatug vedotin and pembrolizumab through an intravenous infusion. This means the medication will be given directly into your vein.

    If you are in the single medication group, you will receive pembrolizumab through an intravenous infusion.

    The frequency and duration of the medication administration will be explained to you by the study team.

  3. Step 3

    Monitoring and assessments

    Throughout the study, your health will be closely monitored. This includes regular check-ups and assessments to see how the treatment is affecting your cancer and overall health.

    You will undergo various tests and evaluations, such as imaging scans, to measure the size of your tumor and check for any changes.

  4. Step 4

    End of study participation

    Your participation in the study will continue until the study ends or until it is determined that the treatment is no longer beneficial for you.

    The study is expected to conclude by February 17, 2029, but your individual participation may end earlier based on your health and the study's findings.

Who can join the trial?

10 criteria

  • Must be 18 years of age or older.
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means you should be fully active or have some symptoms but still be able to carry out light work.
  • Must have adequate baseline hematologic (blood), hepatic (liver), and renal (kidney) function.
  • Must have Stage IIIB, IIIC, or IV non-small cell lung cancer (NSCLC) that cannot be treated with surgery or definitive chemoradiation.
  • If you have non-squamous NSCLC, you must have negative test results for certain genetic changes (EGFR, ALK, ROS1) and no known changes in other specific genes (NTRK, BRAF, RET, MET) that have approved treatments.
  • Must not have small cell elements or large cell neuroendocrine carcinoma.
  • Must be a suitable candidate for treatment with pembrolizumab alone, according to local guidelines.
  • Your tumor must have PD-L1 expression in 50% or more of the tumor cells, confirmed by a local test and later by a central lab test.
  • A tumor sample must be available for testing, either from a recent biopsy or a previous sample taken within the last 6 months. If no sample is available, you must be willing to have a biopsy to obtain one.
  • Must have measurable disease based on RECIST v1.1 criteria, which means the cancer can be measured by scans or other tests. If you had prior radiation therapy, the disease must be measurable outside the treated area or show clear progression.

Who cannot join the trial?

8 criteria

  • Patients with any other type of cancer besides non-small cell lung cancer cannot participate.
  • Patients who have received certain treatments for cancer recently may not be eligible.
  • Patients with serious heart conditions or other severe health issues might be excluded.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients with known allergies to the study drugs or similar drugs cannot participate.
  • Patients with active infections or certain viral infections might be excluded.
  • Patients who are unable to follow the study procedures or attend the required visits may not be eligible.
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Investigated drugs

  • Sigvotatug Vedotin

    is a medication being tested in this clinical trial. It is designed to help the body's immune system fight cancer cells more effectively. This medication is used in combination with another drug to see if it can improve the treatment outcomes for patients with a specific type of lung cancer.

  • Pembrolizumab

    is a medication that helps the immune system detect and fight cancer cells. It is already used in treating various types of cancer, including lung cancer. In this trial, it is being used both alone and in combination with another medication to see if the combination can provide better results for patients with advanced lung cancer.

What is already known about the treatment

  • Sigvotatug Vedotin

    Sigvotatug Vedotin is administered through an intravenous infusion, meaning it is delivered directly into the bloodstream via a vein. It is currently being studied in clinical trials as a potential treatment for non-small cell lung cancer, particularly in cases where the cancer is advanced, cannot be surgically removed, or has spread to other parts of the body. The medication works by targeting and binding to specific proteins on cancer cells, delivering a toxic substance that helps to kill these cells. It is classified as an antibody-drug conjugate, which combines an antibody with a drug to specifically target cancer cells while minimizing damage to normal cells.

  • Pembrolizumab

    Pembrolizumab is also administered through an intravenous infusion. It is an established medication in the treatment of various cancers, including non-small cell lung cancer, and is well-documented in medical literature. Pembrolizumab is used to help the immune system recognize and attack cancer cells by blocking a specific protein that prevents the immune system from effectively targeting these cells. It is classified as an immune checkpoint inhibitor, which enhances the body's natural defenses to fight cancer.

Investigated diseases

Non-small cell lung cancer – Non-small cell lung cancer is a type of lung cancer that begins in the tissues of the lungs. It is the most common form of lung cancer, accounting for a majority of cases. The disease typically starts in the epithelial cells lining the airways. As it progresses, the cancer can grow and spread to nearby tissues and organs. It may also metastasize to distant parts of the body through the bloodstream or lymphatic system. The progression of the disease can vary, with some tumors growing slowly and others advancing more rapidly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517968-36-00Protocol codeC5751003Estimated enrolment745 patientsSponsorPfizer Inc.

sourced from the EU Clinical Trials Register and site verification

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