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NCT06758401 · ClinicalTrials.gov registry record · Phase 3
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.
A Phase 3 study of Non-Small Cell Lung Cancer and Carcinoma, Non-Small Cell Lung, sponsored by Pfizer.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 714
- Enrollment target
- 20
- Study locations
NCT06758401 is a Phase 3 study of Non-Small Cell Lung Cancer and Carcinoma, Non-Small Cell Lung that is actively recruiting participants, run by Pfizer. The registered enrollment target is 714 participants, roughly in line with the 657-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target. The trial reports 20 study locations across 7 states.
The verdict
NCT06758401, a Phase 3 study of Non-Small Cell Lung Cancer and Carcinoma, Non-Small Cell Lung, is actively recruiting participants, sponsored by Pfizer.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 714 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 714 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 657-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
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.
NCT06758401 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Colorado, Illinois, California.
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).
What interventions are being tested in trial NCT06758401?
The interventions under investigation include: Pembrolizumab (DRUG), Sigvotatug Vedotin (DRUG).
Who is sponsoring clinical trial NCT06758401?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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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