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.
Condition(s) studied
Investigational drug(s) / intervention(s)
Sigvotatug Vedotin: MMAE-Antibody Drug Conjugate targeting Integrin Beta-6
Pembrolizumab: Anti-PD-(L)1
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.
Eligibility
Primary outcome measure(s)
- Overall Survival — Baseline to date of death from any cause (Approximately 2 years).
Overall survival defined as the duration from enrollment to death. - Progression Free Survival (PFS) assessed by blinded independent central review (BICR) — From Baseline to to date of first documentation of progression OR death (Approximately 2 years).
Progression-free survival is defined as the time interval from the date of randomization to the date of first documented tumor progression determined by blinded independent central review (BICR) assessment as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or death due to any cause, whichever come first.
Trial sites (389)
| Facility | City | Region | Status |
|---|---|---|---|
| Providence Medical Foundation | Fullerton | California | Recruiting |
| Providence St. Jude Medical Center Virginia K. Crosson Cancer Center and Infusion Center | Fullerton | California | Recruiting |
| Providence St. Jude Medical Center | Fullerton | California | Recruiting |
| St. Jude Heritage Medical Group - Fullerton Plaza Multi-Specialty Clinic (Pulmonary Function Test) | Fullerton | California | Recruiting |
| Intermountain Health Cancer Center Lutheran Hospital | Golden | Colorado | Recruiting |
| Cancer Centers of Colorado St. Mary's Regional Hospital | Grand Junction | Colorado | Recruiting |
| Intermountain Health St. Mary's Regional Hospital | Grand Junction | Colorado | Recruiting |
| Intermountain Health | Grand Junction | Colorado | Recruiting |
| Intermountain Health Lutheran Hospital | Wheat Ridge | Colorado | Recruiting |
| Washington DC Veterans Affairs Medical Center | Washington D.C. | District of Columbia | Recruiting |
| Mid Florida Hematology and Oncology Center | Orange City | Florida | Recruiting |
| BRCR Global | Plantation | Florida | Recruiting |
| Endeavor Health | Elmhurst | Illinois | Recruiting |
| Hope and Healing Cancer Services | Hinsdale | Illinois | Recruiting |
| Advocate Medical Group - Libertyville Oncology | Libertyville | Illinois | Recruiting |
| Endeavor Health | Naperville | Illinois | Recruiting |
| Hope and Healing Cancer Services | New Lenox | Illinois | Recruiting |
| Advocate Christ Medical Center | Oak Lawn | Illinois | Recruiting |
| Advocate Lutheran General Hospital | Park Ridge | Illinois | Recruiting |
| Saint Luke's South Hospital | Overland Park | Kansas | Recruiting |
| Maine Medical Center | Portland | Maine | Recruiting |
| MaineHealth Cancer Care and Blood Disorders Scarborough | Scarborough | Maine | Recruiting |
| MaineHealth Cancer Care and IV Therapy - South Portland | South Portland | Maine | Recruiting |
| Southcoast Centers for Cancer Care | Fairhaven | Massachusetts | Recruiting |
| Southcoast Centers for Cancer Care | Fall River | Massachusetts | Recruiting |
| Corewell Health - Butterworth Hospital | Grand Rapids | Michigan | Recruiting |
| Corewell Health - Lemmen Holton Cancer Pavilion | Grand Rapids | Michigan | Recruiting |
| Corewell Health - Research Specimen Processing Area | Grand Rapids | Michigan | Recruiting |
| Corewell Health Investigational Drug Services | Grand Rapids | Michigan | Recruiting |
| Corewell Health | Grand Rapids | Michigan | Recruiting |
| Minnesota Oncology Hematology, PA | Burnsville | Minnesota | Recruiting |
| Minnesota Oncology Hematology PA | Coon Rapids | Minnesota | Recruiting |
| M Health Fairview Cancer Clinic-Edina | Edina | Minnesota | Recruiting |
| Minnesota Oncology Hematology PA | Edina | Minnesota | Recruiting |
| Minnesota Oncology Hematology PA | Maple Grove | Minnesota | Recruiting |
| M Health Fairview St. John's Hospital | Maplewood | Minnesota | Recruiting |
| Minnesota Oncology Hematology PA | Maplewood | Minnesota | Recruiting |
| Hennepin County Medical Center | Minneapolis | Minnesota | Recruiting |
| North Memorial Health Cancer Center | Robbinsdale | Minnesota | Recruiting |
| Metro Minnesota Community Oncology Research Consortium (MMCORC) | Saint Louis Park | Minnesota | Recruiting |
+ 349 more sites — see the full list on the official registry below.
On this site
📄 Keytruda (pembrolizumab) drug profile →More Pfizer trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06758401 on ClinicalTrials.gov ↗ ← All trials in Spain