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)

Status: Recruiting
Location: See all (150) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants must meet the following criteria:

‣ Have pathologically confirmed Stage IIIB or IIIC NSCLC and not be a candidate for surgical resection or definitive chemoradiation, or Stage IV NSCLC per the AJCC Staging Manual (Version 8.0) and the UICC Staging System (Eighth edition).

⁃ Participants with non-squamous histology must have documented negative test results for EGFR, ALK, and ROS1 AGAs and no known AGAs in NTRK, BRAF, RET, MET, or other AGAs with approved front-line therapies per local standard of care.

⁃ Large cell neuroendocrine carcinoma is excluded.

⁃ Candidate for treatment with pembrolizumab monotherapy per local guidelines.

• Tumor has PD-L1 expression in ≥50% of tumor cells (TPS ≥50%) as determined by local testing

• Measurable disease based on RECIST v1.1 per investigator.

• Resolution of acute effects of any prior therapy to either baseline severity or NCI CTCAE Grade 1 or less (except for AEs not constituting a safety risk in the investigator's judgment), unless otherwise excluded.

Locations
United States
California
Providence St. Jude Medical Center
RECRUITING
Fullerton
Providence St. Jude Medical Center Virginia K. Crosson Cancer Center and Infusion Center
RECRUITING
Fullerton
St. Jude Heritage Medical Group - Fullerton Plaza Multi-Specialty Clinic (Pulmonary Function Test)
RECRUITING
Fullerton
Colorado
Intermountain Health Lutheran Hospital
RECRUITING
Golden
Lutheran Hospital - Cancer Centers of Colorado
RECRUITING
Golden
Cancer Centers of Colorado St. Mary's Regional Hospital
RECRUITING
Grand Junction
Intermountain Health
RECRUITING
Grand Junction
Intermountain Health St. Mary's Regional Hospital
RECRUITING
Grand Junction
Florida
Mid Florida Hematology and Oncology Center
RECRUITING
Orange City
BRCR Global
RECRUITING
Plantation
Illinois
Hope and Healing Cancer Services
RECRUITING
Hinsdale
Hope and Healing Cancer Services
RECRUITING
New Lenox
Maine
Maine Medical Center
RECRUITING
Portland
MaineHealth Cancer Care - Scarborough
RECRUITING
Scarborough
MaineHealth Cancer Care and IV Therapy - South Portland
RECRUITING
South Portland
Minnesota
Minnesota Oncology Hematology, PA
RECRUITING
Burnsville
Minnesota Oncology Hematology PA
RECRUITING
Coon Rapids
M Health Fairview Cancer Clinic-Edina
RECRUITING
Edina
Minnesota Oncology Hematology PA
RECRUITING
Edina
Minnesota Oncology Hematology PA
RECRUITING
Fridley
Minnesota Oncology Hematology PA
RECRUITING
Maple Grove
M Health Fairview St. John's Hospital
RECRUITING
Maplewood
Minnesota Oncology Hematology PA
RECRUITING
Maplewood
Hennepin County Medical Center
RECRUITING
Minneapolis
Minnesota Oncology Hematology PA
RECRUITING
Minneapolis
North Memorial Health Cancer Center
RECRUITING
Robbinsdale
Park Nicollet Frauenshuh Cancer Center
RECRUITING
Saint Louis Park
Regions Hospital
RECRUITING
Saint Paul
Minnesota Oncology Hematology, P.A. Cornerstone Medical Specialty Center
RECRUITING
Woodbury
Mississippi
Jackson Oncology Associates, PLLC
RECRUITING
Jackson
Jackson Oncology Associates, PLLC
RECRUITING
Jackson
North Carolina
Carolina Cancer Research Center
RECRUITING
Wilson
Nebraska
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Fremont
RECRUITING
Fremont
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island
RECRUITING
Grand Island
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Regional
RECRUITING
Grand Island
Cancer Partners of Nebraska - April Sampson Cancer Center
RECRUITING
Lincoln
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
RECRUITING
Omaha
Oncology Hematology West P.C. dba Nebraska Cancer Specialists - Methodist
RECRUITING
Omaha
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Bergan
RECRUITING
Omaha
New York
Hematology Oncology Associates of Rockland
RECRUITING
Nyack
Texas
The University of Texas, MD Anderson Cancer Center - Woodlands
NOT_YET_RECRUITING
Conroe
Renovatio Clinical - El Paso
RECRUITING
El Paso
The University of Texas MD Anderson Cancer Center Clinical Research Imaging
NOT_YET_RECRUITING
Houston
The University of Texas MD Anderson Cancer Center Diagnostic Imaging
NOT_YET_RECRUITING
Houston
The University of Texas MD Anderson Cancer Center Investigational Pharmacy Services
NOT_YET_RECRUITING
Houston
The University of Texas, MD Anderson Cancer Center - West Houston
NOT_YET_RECRUITING
Houston
The University of Texas, MD Anderson Cancer Center- Interventional Radiology
NOT_YET_RECRUITING
Houston
University of Texas MD Anderson Cancer Center
NOT_YET_RECRUITING
Houston
Community Clinical Trials
NOT_YET_RECRUITING
Kingwood
The University of Texas, MD Anderson Cancer Center - League City
NOT_YET_RECRUITING
League City
The University of Texas, MD Anderson Cancer Center - Sugar Land
NOT_YET_RECRUITING
Sugar Land
Renovatio Clinical
RECRUITING
The Woodlands
Woodlands Radiology
RECRUITING
The Woodlands
Other Locations
Argentina
Fundación Respirar
NOT_YET_RECRUITING
Ciudad Autónoma De Buenos Aires
Australia
Sunshine Coast University Hospital
NOT_YET_RECRUITING
Birtinya
Gympie Hospital
NOT_YET_RECRUITING
Gympie
Nambour General Hospital
NOT_YET_RECRUITING
Nambour
Belgium
Algemeen Ziekenhuis klina
RECRUITING
Brasschaat
UZ Brussel
RECRUITING
Brussels
AZ Sint-Maarten
RECRUITING
Mechelen
Bulgaria
Complex Oncology Center - Burgas
RECRUITING
Burgas
MBAL Uni Hospital
NOT_YET_RECRUITING
Panagyurishte
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
NOT_YET_RECRUITING
Sofia
MHAT for Women's Health Nadezhda
NOT_YET_RECRUITING
Sofia
China
Beijing Cancer hospital
NOT_YET_RECRUITING
Beijing
Beijing Chest Hospital,Capital Medical University
NOT_YET_RECRUITING
Beijing
Huizhou Central People's Hospital
RECRUITING
Huizhou
Jinan Central Hospital
NOT_YET_RECRUITING
Jinan
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Shanghai Chest Hospital
NOT_YET_RECRUITING
Shanghai
Taizhou Hospital of Zhejiang Province
NOT_YET_RECRUITING
Taizhou
The First Affiliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITING
Wenzhou
Wuhan Union Hospital Cancer Center
NOT_YET_RECRUITING
Wuhan
The Affiliated Hospital of Xuzhou Medical College
NOT_YET_RECRUITING
Xuzhou
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
France
Centre Hospitalier de Cholet
NOT_YET_RECRUITING
Cholet
Centre Hospitalier Intercommunal de Créteil
NOT_YET_RECRUITING
Créteil
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
RECRUITING
Marseille
Centre de Cancérologie du Grand Montpellier
NOT_YET_RECRUITING
Montpellier
Institut Curie
RECRUITING
Paris
CHU Bordeaux Haut-Leveque
RECRUITING
Pessac
Centre Hospitalier de Cornouaille Quimper - Concarneau
NOT_YET_RECRUITING
Quimper
Institut de Cancérologie de l'Ouest
NOT_YET_RECRUITING
Saint-herblain
Centre Hospitalier intercommunal de Toulon La Seyne sur Mer
NOT_YET_RECRUITING
Toulon
CHU de Toulouse - Hopital Larrey
NOT_YET_RECRUITING
Toulouse
Germany
Klinikum Esslingen
RECRUITING
Esslingen Am Neckar
Greece
Errikos Dunant Hospital Center
RECRUITING
Athens
Metropolitan General Hospital
RECRUITING
Athens
Metropolitan Hospital
NOT_YET_RECRUITING
Athens
Thoracic General Hospital of Athens I Sotiria
NOT_YET_RECRUITING
Athens
University General Hospital of Larissa
NOT_YET_RECRUITING
Larissa
Hygeia Hospital
NOT_YET_RECRUITING
Marousi
Agios Loukas Clinic
NOT_YET_RECRUITING
Thessaloniki
European Interbalkan Medical Center
NOT_YET_RECRUITING
Thessaloniki
Israel
Shaare Zedek Medical Center
NOT_YET_RECRUITING
Jerusalem
Rabin Medical Center
RECRUITING
Petah Tikva
Italy
Azienda Ospedaliera San Giuseppe Moscati
NOT_YET_RECRUITING
Avellino
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori
NOT_YET_RECRUITING
Meldola
Ospedale San Raffaele
NOT_YET_RECRUITING
Milan
Istituto Nazionale Tumori IRCCS Fondazione Pascale
NOT_YET_RECRUITING
Napoli
Istituto Nazionale Tumori Regina Elena
NOT_YET_RECRUITING
Rome
Ospedale Isola Tiberina - Gemelli Isola
NOT_YET_RECRUITING
Rome
Japan
National Hospital Organization Asahikawa Medical Center
NOT_YET_RECRUITING
Asahikawa
Nippon Medical School Hospital
NOT_YET_RECRUITING
Bunkyo-ku
National Cancer Center Hospital
NOT_YET_RECRUITING
Chuo-ku
National Hospital Organization Kyushu Cancer Center
RECRUITING
Fukuoka
National Hospital Organization Kyushu Medical Center
NOT_YET_RECRUITING
Fukuoka
Kobe City Medical Center General Hospital
RECRUITING
Kobe
The Cancer Institute Hospital of JFCR
NOT_YET_RECRUITING
Koto
Kurume University Hospital
NOT_YET_RECRUITING
Kurume
National Hospital Organization Kyoto Medical Center
RECRUITING
Kyoto
National Hospital Organization Tokyo Medical Center
NOT_YET_RECRUITING
Meguro-ku
National Hospital Organization Okayama Medical Center
RECRUITING
Okayama
Osaka International Cancer Institute
NOT_YET_RECRUITING
Osaka
Gunma Prefectural Cancer Center
NOT_YET_RECRUITING
Otashi
NHO Kinki Chuo Chest Medical Center
NOT_YET_RECRUITING
Sakai
Sendai Kousei Hospital
NOT_YET_RECRUITING
Sendai
The University of Osaka Hospital
NOT_YET_RECRUITING
Suita
Mie Chuo Medical Center
RECRUITING
Tsu
Yamagata University Hospital
RECRUITING
Yamagata
Kanagawa cancer center
NOT_YET_RECRUITING
Yokohama
Netherlands
Ziekenhuis St. Jansdal
NOT_YET_RECRUITING
Harderwijk
St. Antonius Ziekenhuis, locatie Utrecht
NOT_YET_RECRUITING
Utrecht
Poland
Instytut MSF Sp zoo
RECRUITING
Lodz
Instytut Genetyki i Immunologii GENIM
RECRUITING
Lublin
Med-Polonia Sp. z o. o.
RECRUITING
Poznan
Republic of Korea
Pusan National University Hospital
RECRUITING
Busan
Kyungpook National University Chilgok Hospital
NOT_YET_RECRUITING
Deagu
Chonnam National University Hwasun Hospital
RECRUITING
Hwasun-gun
Seoul National University Bundang Hospital
NOT_YET_RECRUITING
Seongnam
Boramae Medical Center
NOT_YET_RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
The Catholic University Of Korea St. Vincent's Hospital
RECRUITING
Suwon
Slovakia
Fakultna nemocnica Trnava
NOT_YET_RECRUITING
Trnava
Spain
Hospital Universitari Dexeus
NOT_YET_RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital General Universitario de Elche
RECRUITING
Elche
Hospital Jerez de la Frontera
RECRUITING
Jerez De La Frontera
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Fundación Jiménez Díaz
NOT_YET_RECRUITING
Madrid
Hospital Quirón Málaga
NOT_YET_RECRUITING
Málaga
Hospital Quironsalud Malaga
NOT_YET_RECRUITING
Málaga
Hospital Universitario Virgen Del Rocio
RECRUITING
Seville
Hospital Clinico de Valencia
NOT_YET_RECRUITING
Valencia
Taiwan
Chang Gung Memorial Hospital at Kaohsiung
NOT_YET_RECRUITING
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
NOT_YET_RECRUITING
Kaohsiung City
Chi Mei Hospital - Liouying Branch
NOT_YET_RECRUITING
Tainan City
National Cheng Kung University Hospital
NOT_YET_RECRUITING
Tainan City
National Taiwan University Hospital
NOT_YET_RECRUITING
Taipei
Taipei Veterans General Hospital
NOT_YET_RECRUITING
Taipei
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2025-07-23
Estimated Completion Date: 2029-03-01
Participants
Target number of participants: 714
Treatments
Experimental: Sigvotatug Vedotin with Pembrolizumab
Participants will receive Sigvotatug Vedotin, administered as an IV infusion and pembrolizumab, administered as an IV infusion.
Active_comparator: Pembrolizumab Monotherapy
Participants will receive pembrolizumab, administered as an IV infusion.
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov

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