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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 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Sigvotatug Vedotin
Study Locations (20)
Colorado
- Intermountain Health Lutheran Hospital — Golden
- lntermountain Health Cancer Center at Lutheran — Golden
- Cancer Centers of Colorado St. Mary's Regional Hospital — Grand Junction
- Intermountain Health St. Mary's Regional Hospital — Grand Junction
- Intermountain Health — Grand Junction
Illinois
- Endeavor Health — Elmhurst
- Hope and Healing Cancer Services — Hinsdale
- Endeavor Health — Naperville
- Hope and Healing Cancer Services — New Lenox
California
- Providence St. Jude Medical Center Virginia K. Crosson Cancer Center and Infusion Center — Fullerton
- Providence St. Jude Medical Center — Fullerton
- St. Jude Heritage Medical Group - Fullerton Plaza Multi-Specialty Clinic (Pulmonary Function Test) — Fullerton
Maine
- Maine Medical Center — Portland
- MaineHealth Cancer Care - Scarborough — Scarborough
- MaineHealth Cancer Care and IV Therapy - South Portland — South Portland
Florida
- Mid Florida Hematology and Oncology Center — Orange City
- BRCR Global — Plantation
Minnesota
- Minnesota Oncology Hematology, PA — Burnsville
- Minnesota Oncology Hematology PA — Coon Rapids
District of Columbia
- Washington DC Veterans Affairs Medical Center — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 714 participants |
| Start Date | 2025-07-23 |
| Est. Completion | 2029-03-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06758401
The ClinicalTrials.gov registry entry for NCT06758401 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 714 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06758401 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Colorado, Illinois, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06758401 about?
NCT06758401 is a clinical study titled "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.". 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 im...
What is the current status of trial NCT06758401?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 714 participants. The study started on 2025-07-23. Estimated completion is 2029-03-01.
What conditions does trial NCT06758401 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung, Carcinoma, Non-Small-Cell Lung (NSCLC). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06758401?
The interventions under investigation include: Pembrolizumab (DRUG), Sigvotatug Vedotin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06758401?
This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06758401 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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