Be6A Lung-02Sigvotatug Vedotin and Pembrolizumab for PD-L1 High Non-Small Cell Lung Cancer
Sigvotatug Vedotin
+ Pembrolizumab
Bronchial Neoplasms+10
+ Carcinoma
+ Carcinoma, Bronchogenic
Treatment Study
Summary
Study start date: July 23, 2025
Actual date on which the first participant was enrolled.This study is about finding out how well a new combination of treatments works for people with a specific type of lung cancer called non-small cell lung cancer (NSCLC). The focus is on patients whose cancer cells show high levels of a protein called PD-L1, which is known to help cancer hide from the immune system. The study aims to see if adding a drug called Sigvotatug Vedotin to an existing treatment, pembrolizumab, is more effective than using pembrolizumab alone. This research is important because it could lead to better treatment options for patients with advanced lung cancer, where current treatments might not be fully effective. Participants in this study will visit the clinic to receive pembrolizumab every six weeks through an IV, which means the medicine is given directly into their veins. Half of the participants will also receive Sigvotatug Vedotin every two weeks in addition to pembrolizumab. The study will monitor how each participant responds to the treatment during regular check-ups. Pembrolizumab can be given for up to two years, while Sigvotatug Vedotin continues as long as it's effective against the cancer. The goal is to see if this new treatment combination can offer improved results for patients with this challenging condition.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.714 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 315 locations
Providence St. Jude Medical Center Virginia K. Crosson Cancer Center and Infusion Center
Fullerton, United StatesProvidence St. Jude Medical Center
Fullerton, United StatesSt. Jude Heritage Medical Group - Fullerton Plaza Multi-Specialty Clinic (Pulmonary Function Test)
Fullerton, United States