Recruiting

Be6A Lung-02Sigvotatug Vedotin and Pembrolizumab for PD-L1 High Non-Small Cell Lung Cancer

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Sigvotatug Vedotin

+ Pembrolizumab

Drug
Who is being recruted

Bronchial Neoplasms+10

+ Carcinoma

+ Carcinoma, Bronchogenic

Over 18 Years
+27 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: July 2025
See protocol details

Summary

Principal SponsorPfizer
Study ContactPfizer CT.gov Call Center
Last updated: March 13, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleAN OPEN-LABEL, RANDOMIZED, CONTROLLED PHASE 3 STUDY OF SIGVOTATUG VEDOTIN IN COMBINATION WITH PEMBROLIZUMAB COMPARED WITH PEMBROLIZUMAB MONOTHERAPY AS FIRST-LINE TREATMENT IN PARTICIPANTS WITH PD-L1 HIGH (≥50% OF TUMOR CELLS EXPRESSING PD-L1), LOCALLY ADVANCED, UNRESECTABLE, OR METASTATIC NON-SMALL CELL LUNG CANCER (BE6A LUNG-02)
NCT06758401
Principal SponsorPfizer
Study ContactPfizer CT.gov Call Center
Last updated: March 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

714 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Bronchial NeoplasmsCarcinomaCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

Criteria

6 inclusion criteria required to participate
Tumor has PD-L1 expression in ≥50% of tumor cells (TPS ≥50%) as determined by local testing

Resolution of acute effects of any prior therapy to either baseline severity or NCI CTCAE Grade 1 or less (except for AEs not constituting a safety risk in the investigator's judgment), unless otherwise excluded.

Participants with non-squamous histology must have documented negative test results for EGFR, ALK, and ROS1 AGAs and no known AGAs in NTRK, BRAF, RET, MET, or other AGAs with approved front-line therapies per local standard of care.

Candidate for treatment with pembrolizumab monotherapy per local guidelines.

Show More Criteria

21 exclusion criteria prevent from participating
Prior radiotherapy to the lung within 6 months of first dose of study intervention, referencing the last date radiotherapy was received.

Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.

Known or suspected hypersensitivity, intolerance, or contraindication to any excipient contained in the drug formulation of sigvotatug vedotin or pembrolizumab.

Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive Sigvotatug Vedotin, administered as an IV infusion and pembrolizumab, administered as an IV infusion.

Group II

Active Comparator
Participants will receive pembrolizumab, administered as an IV infusion.

Study 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

Recruiting

Institut Curie

Paris, FranceOpen Institut Curie in Google Maps
Recruiting

Providence St. Jude Medical Center Virginia K. Crosson Cancer Center and Infusion Center

Fullerton, United States
Recruiting

Providence St. Jude Medical Center

Fullerton, United States
Recruiting

St. Jude Heritage Medical Group - Fullerton Plaza Multi-Specialty Clinic (Pulmonary Function Test)

Fullerton, United States
Recruiting
315 Study Centers