Study on How the Combination of Sigvotatug Vedotin and Pembrolizumab Works in People with Non-Small Cell Lung Cancer with High PD-L1 Levels

Sponsor: Pfizer

Sponsor score: 60

ClinicalTrials ID:NCT06758401

This clinical trial is testing a new combination of drugs, Sigvotatug Vedotin and pembrolizumab, to see if it works better than pembrolizumab alone in treating non-small cell lung cancer (NSCLC) with high levels of PD-L1, a protein that helps control immune responses.

Patient Parameters

Parameter	Options

Program Overview

The study aims to compare the effectiveness of a new treatment combination, Sigvotatug Vedotin plus pembrolizumab, against pembrolizumab alone in patients with non-small cell lung cancer (NSCLC) that has high levels of PD-L1. PD-L1 is a protein that helps regulate the immune system. Participants must have NSCLC at Stage 3 or 4 and show PD-L1 levels in more than 50% of their cancer cells. All participants will receive pembrolizumab every six weeks through an IV infusion. Half of the participants will also receive Sigvotatug Vedotin every two weeks. Pembrolizumab may be given for up to two years, while Sigvotatug Vedotin will continue until the cancer stops responding. Regular clinic visits will monitor participants' progress.

Eligibility Criteria

Inclusion Criteria

Have Stage IIIB, IIIC, or IV non-small cell lung cancer (NSCLC) that cannot be treated with surgery or chemoradiation.
Have non-squamous NSCLC with negative test results for certain genetic mutations (EGFR, ALK, ROS1) and no known mutations in other genes with approved treatments.
Not have large cell neuroendocrine carcinoma.
Be eligible for pembrolizumab treatment according to local guidelines.
Have a tumor with PD-L1 expression in 50% or more of the cancer cells.
Have measurable disease based on specific medical criteria.
Have recovered from any side effects of previous treatments to a mild level, unless otherwise specified.

Exclusion Criteria

Have a life expectancy of less than 3 months.
Have medical or psychiatric conditions that increase the risk of participating in the study.
Have had another cancer within the last 3 years or have residual disease from a previous cancer.
Have allergies or intolerances to the study drugs.
Have certain lung conditions or low lung function.
Have active brain lesions, unless they have been treated and are stable.
Have had major surgery within 21 days or minor surgery within 7 days before starting the study.
Have received a live vaccine within 30 days before starting the study.
Have severe nerve damage or uncontrolled diabetes.
Have had severe immune-related side effects from previous treatments.
Have a history of autoimmune disease requiring treatment in the past 2 years.
Have had an organ or bone marrow transplant.
Are taking high-dose steroids or immune suppressants.
Have had certain previous cancer treatments or infections like HIV, hepatitis B, or hepatitis C.
Have severe heart or brain conditions within the last 6 months.

Locations

FACILITY	ZIP	CITY	STATE
Hope and Healing Cancer Services	60521	Hinsdale	Illinois
Hope and Healing Cancer Services	60451	New Lenox	Illinois
Hematology Oncology Associates of Rockland	10960	Nyack	New York

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