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. (NCT06758401)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Providence Medical Foundation — Fullerton, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (372 Sites)
Showing the first 25 of 372 sites.
- Providence Medical Foundation — Fullerton, California
- Providence St. Jude Medical Center Virginia K. Crosson Cancer Center and Infusion Center — Fullerton, California
- St. Jude Heritage Medical Group - Fullerton Plaza Multi-Specialty Clinic (Pulmonary Function Test) — Fullerton, California
- Intermountain Health Cancer Center Lutheran Hospital — Golden, Colorado
- Cancer Centers of Colorado St. Mary's Regional Hospital — Grand Junction, Colorado
- Intermountain Health St. Mary's Regional Hospital — Grand Junction, Colorado
- Intermountain Health — Grand Junction, Colorado
- Intermountain Health Lutheran Hospital — Wheat Ridge, Colorado
- Washington DC Veterans Affairs Medical Center — Washington D.C., District of Columbia
- Mid Florida Hematology and Oncology Center — Orange City, Florida
- BRCR Global — Plantation, Florida
- Endeavor Health — Elmhurst, Illinois
- Hope and Healing Cancer Services — Hinsdale, Illinois
- Endeavor Health — Naperville, Illinois
- Hope and Healing Cancer Services — New Lenox, Illinois
- Saint Luke's South Hospital — Overland Park, Kansas
- Maine Medical Center — Portland, Maine
- MaineHealth Cancer Care - Scarborough — Scarborough, Maine
- MaineHealth Cancer Care and Blood Disorders Scarborough — Scarborough, Maine
- Southcoast Centers for Cancer Care — Fairhaven, Massachusetts
- Southcoast Centers for Cancer Care — Fall River, Massachusetts
- Corewell Health - Butterworth Hospital — Grand Rapids, Michigan
- Corewell Health - Lemmen Holton Cancer Pavilion — Grand Rapids, Michigan
- Corewell Health - Research Specimen Processing Area — Grand Rapids, Michigan
- Corewell Health Investigational Drug Services — Grand Rapids, Michigan
📞 Contact the Study Coordinator
Phone: (800) 718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- PhI/II Study of Amivantamab and Tepotinib Combo in MET-altered Non-small Cell Lung Cancer — Houston, Texas
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Explore by condition: All Non-Small Cell Lung Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.