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.
Public ClinicalTrials.gov record NCT06758401. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
AN 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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study is to compare how the new combination treatment (Sigvotatug Vedotin plus pembrolizumab) works compared to pembrolizumab alone in patients with non-small cell lung cancer (NSCLC) with high levels of PD-L1. This is a protein that acts as a kind of "brake" to keep the body's immune responses under control. The study is seeking for participants who: * Are confirmed to have NSCLC (Stage 3 or 4). * Have PD-L1 levels in more than 50% of the cancer cells. All participants in this study will receive pembrolizumab at the study clinic once every 6 weeks as an intravenous (IV) infusion (give directly into a vein). In addition, half of the participants will also receive Sigvotatug Vedotin once every 2 weeks as an IV infusion in addition to receiving pembrolizumab. Participants may receive pembrolizumab for up to about two years. Those participants taking Sigvotatug Vedotin can continue until their NSCLC is no longer responding. The study team will monitorsee how each participant is doing with the study treatment during regular visits at the clinic.
Study identification
- NCT ID
- NCT06758401
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 714 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 22, 2025
- Primary completion
- Sep 4, 2028
- Completion
- Feb 28, 2029
- Last update posted
- Jul 21, 2026
2025 – 2029
United States locations
- U.S. sites
- 75
- U.S. states
- 18
- U.S. cities
- 50
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Providence Medical Foundation | Fullerton | California | 92835 | Recruiting |
| Providence St. Jude Medical Center Virginia K. Crosson Cancer Center and Infusion Center | Fullerton | California | 92835 | Recruiting |
| St. Jude Heritage Medical Group - Fullerton Plaza Multi-Specialty Clinic (Pulmonary Function Test) | Fullerton | California | 92835 | Recruiting |
| Intermountain Health Cancer Center Lutheran Hospital | Golden | Colorado | 80401 | Recruiting |
| Cancer Centers of Colorado St. Mary's Regional Hospital | Grand Junction | Colorado | 81501 | Recruiting |
| Intermountain Health St. Mary's Regional Hospital | Grand Junction | Colorado | 81501 | Recruiting |
| Intermountain Health | Grand Junction | Colorado | 81505 | Recruiting |
| Intermountain Health Lutheran Hospital | Wheat Ridge | Colorado | 80401 | Recruiting |
| Washington DC Veterans Affairs Medical Center | Washington D.C. | District of Columbia | 20422 | Recruiting |
| Mid Florida Hematology and Oncology Center | Orange City | Florida | 32763 | Recruiting |
| BRCR Global | Plantation | Florida | 33322 | Recruiting |
| Endeavor Health | Elmhurst | Illinois | 60126 | Recruiting |
| Hope and Healing Cancer Services | Hinsdale | Illinois | 60521 | Recruiting |
| Endeavor Health | Naperville | Illinois | 60540 | Recruiting |
| Hope and Healing Cancer Services | New Lenox | Illinois | 60451 | Recruiting |
| Saint Luke's South Hospital | Overland Park | Kansas | 66213 | Recruiting |
| Maine Medical Center | Portland | Maine | 04102 | Recruiting |
| MaineHealth Cancer Care - Scarborough | Scarborough | Maine | 04074 | Recruiting |
| MaineHealth Cancer Care and Blood Disorders Scarborough | Scarborough | Maine | 04074 | Recruiting |
| Southcoast Centers for Cancer Care | Fairhaven | Massachusetts | 02719 | Recruiting |
| Southcoast Centers for Cancer Care | Fall River | Massachusetts | 02720 | Recruiting |
| Corewell Health - Butterworth Hospital | Grand Rapids | Michigan | 49503 | Not yet recruiting |
| Corewell Health - Lemmen Holton Cancer Pavilion | Grand Rapids | Michigan | 49503 | Not yet recruiting |
| Corewell Health - Research Specimen Processing Area | Grand Rapids | Michigan | 49503 | Not yet recruiting |
| Corewell Health Investigational Drug Services | Grand Rapids | Michigan | 49503 | Not yet recruiting |
| Corewell Health | Grand Rapids | Michigan | 49503 | Not yet recruiting |
| Minnesota Oncology Hematology, PA | Burnsville | Minnesota | 55337 | Recruiting |
| Minnesota Oncology Hematology PA | Coon Rapids | Minnesota | 55433 | Recruiting |
| M Health Fairview Cancer Clinic-Edina | Edina | Minnesota | 55435 | Recruiting |
| Minnesota Oncology Hematology PA | Edina | Minnesota | 55435 | Recruiting |
| Minnesota Oncology Hematology PA | Maple Grove | Minnesota | 55369 | Recruiting |
| M Health Fairview St. John's Hospital | Maplewood | Minnesota | 55109 | Recruiting |
| Minnesota Oncology Hematology PA | Maplewood | Minnesota | 55109 | Recruiting |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | Recruiting |
| North Memorial Health Cancer Center | Robbinsdale | Minnesota | 55422 | Recruiting |
| Metro Minnesota Community Oncology Research Consortium (MMCORC) | Saint Louis Park | Minnesota | 55426 | Recruiting |
| Park Nicollet Frauenshuh Cancer Center | Saint Louis Park | Minnesota | 55426 | Recruiting |
| Regions Hospital | Saint Paul | Minnesota | 55101 | Recruiting |
| Minnesota Oncology Hematology, P.A. Cornerstone Medical Specialty Center | Woodbury | Minnesota | 55125 | Recruiting |
| Jackson Oncology Associates, PLLC | Jackson | Mississippi | 39202 | Recruiting |
| Jackson Oncology Associates, PLLC | Jackson | Mississippi | 39216 | Recruiting |
| Saint Luke's Cancer Institute | Kansas City | Missouri | 64111 | Recruiting |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | Recruiting |
| Saint Luke's East Hospital | Lee's Summit | Missouri | 64086 | Recruiting |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists - Fremont | Fremont | Nebraska | 68025 | Recruiting |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island | Grand Island | Nebraska | 68803 | Recruiting |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists - Regional | Grand Island | Nebraska | 68803 | Recruiting |
| Cancer Partners of Nebraska | Lincoln | Nebraska | 68516 | Recruiting |
| Oncology Hematology West P.C. dba Nebraska Cancer Specialists - Methodist | Omaha | Nebraska | 68114 | Recruiting |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists - Bergan | Omaha | Nebraska | 68124 | Recruiting |
| Oncology Hematology West P.C. dba Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | Recruiting |
| Hematology Oncology Associates of Rockland | Nyack | New York | 10960 | Recruiting |
| Brody School of Medicine at East Carolina University | Greenville | North Carolina | 27834 | Recruiting |
| ECU Health Medical Center | Greenville | North Carolina | 27834 | Recruiting |
| Carolina Cancer Research Center | Wilson | North Carolina | 27893 | Recruiting |
| University Hospitals Seidman Cancer Center at UH Avon Health Center | Avon | Ohio | 44011 | Recruiting |
| Gabrail Cancer Center Research | Canton | Ohio | 44718 | Recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | Recruiting |
| University Hospitals Seidman Cancer Center at UH Mentor Health Center | Mentor | Ohio | 44060 | Recruiting |
| UH Minoff Health Center at Chagrin Highlands | Orange | Ohio | 44122 | Recruiting |
| The University of Texas, MD Anderson Cancer Center - Woodlands | Conroe | Texas | 77384 | Recruiting |
| Renovatio Clinical - El Paso | El Paso | Texas | 79915 | Recruiting |
| The University of Texas MD Anderson Cancer Center Diagnostic Imaging | Houston | Texas | 77030 | Recruiting |
| The University of Texas MD Anderson Cancer Center Investigational Pharmacy Services | Houston | Texas | 77030 | Recruiting |
| The University of Texas, MD Anderson Cancer Center- Interventional Radiology | Houston | Texas | 77030 | Recruiting |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
| The University of Texas MD Anderson Cancer Center Clinical Research Imaging | Houston | Texas | 77054 | Recruiting |
| The University of Texas, MD Anderson Cancer Center - West Houston | Houston | Texas | 77079 | Recruiting |
| Community Clinical Trials | Kingwood | Texas | 77339 | Recruiting |
| The University of Texas, MD Anderson Cancer Center - League City | League City | Texas | 77573 | Recruiting |
| The University of Texas, MD Anderson Cancer Center - Sugar Land | Sugar Land | Texas | 77478 | Recruiting |
| Renovatio Clinical | The Woodlands | Texas | 77380 | Recruiting |
| Woodlands Radiology | The Woodlands | Texas | 77381 | Recruiting |
| American Oncology Network Vista Oncology Division-West office | Olympia | Washington | 98502 | Recruiting |
| American Oncology Network Vista Oncology Division-East office | Olympia | Washington | 98506 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 297 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06758401, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 21, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06758401 live on ClinicalTrials.gov.