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A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)
Sponsor: Pfizer
Summary
The purpose of this study is to understand if PF-08046054 alone works well compared to standard-of-care docetaxel alone in participants with non-small cell lung cancer (NSCLC) with PD-L1 expression greater than or equal to 1% and had cancer progression during or after treatment with PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted treatment regimen(s) for participants with known actionable genomic alterations (AGAs). Participants in this study must have cancer that has spread through their body or can't be removed with surgery or treated with definitive radiation. Participants will randomly (like a flip of the coin) be assigned to either the PF-08046054 treatment group or the docetaxel treatment group. Participants in the PF-08046054 treatment group will receive an IV infusion (injected directly into the veins) twice during each 21-day cycle. Participants in the docetaxel treatment group will receive an IV infusion once during each 21-day cycle. Study participation may be up to 5 years if the participant's NSCLC is responding to treatment. The study team will see how each participant is doing with the study treatment during regular visits at the clinic.
Official title: PADL1NK-005: A Randomized, Phase 3, Open-Label Study to Evaluate PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
680
Start Date
2025-09-29
Completion Date
2032-03-10
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
PF-08046054
Antibody Drug Conjugate Participants will receive PF-08046054, administered as an IV infusion.
Docetaxel monotherapy
Participants will receive Docetaxel, administered as an IV infusion.
Locations (280)
Alabama Oncology
Alabaster, Alabama, United States
Alabama Oncology
Bessemer, Alabama, United States
Alabama Oncology, Bruno Cancer Center
Birmingham, Alabama, United States
Alabama Oncology
Birmingham, Alabama, United States
Alabama Oncology
Birmingham, Alabama, United States
Alabama Oncology
Birmingham, Alabama, United States
Alabama Oncology
Birmingham, Alabama, United States
Southern Cancer Center
Daphne, Alabama, United States
Southern Cancer Center, PC
Foley, Alabama, United States
Alaska Oncology and Hematology
Anchorage, Alaska, United States
Highlands Oncology Group, PA
Fayetteville, Arkansas, United States
Highlands Oncology Group, PA
Rogers, Arkansas, United States
Highlands Oncology Group, PA
Springdale, Arkansas, United States
Highlands Oncology Group
Springdale, Arkansas, United States
Providence Medical Foundation
Fullerton, California, United States
Providence St. Jude Medical Center
Fullerton, California, United States
Rocky Mountain Cancer Centers,LLP
Denver, Colorado, United States
Medical Oncology Hematology Consultants, PA
Newark, Delaware, United States
Cancer Care Centers of Brevard, Inc.
Palm Bay, Florida, United States
Florida Cancer Affiliates - Panama City
Panama City, Florida, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
Illinois CancerCare- Bloomington
Bloomington, Illinois, United States
Illinois Cancer Specialists
Chicago, Illinois, United States
Illinois CancerCare Galesburg
Galesburg, Illinois, United States
Accellacare of Duly
Lisle, Illinois, United States
Illinois CancerCare-Ottawa-Fox River Cancer Center
Ottawa, Illinois, United States
Illinois CancerCare- Pekin
Pekin, Illinois, United States
Illinois Cancer Care
Peoria, Illinois, United States
Illinois CancerCare-Peru - Valley Regional Cancer Center
Peru, Illinois, United States
Illinois CancerCare - Washington
Washington, Illinois, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Maryland Oncology Hematology, P.A.
Annapolis, Maryland, United States
Maryland Oncology Hematology, P.A.
Bethesda, Maryland, United States
Maryland Oncology Hematology, PA
Brandywine, Maryland, United States
Maryland Oncology Hematology
Columbia, Maryland, United States
Maryland Oncology Hematology P.A.
Germantown, Maryland, United States
Maryland Oncology Hematology, P.A
Largo, Maryland, United States
Maryland Oncology Hematology PA
Rockville, Maryland, United States
Maryland Oncology Hematology, P.A.
Silver Spring, Maryland, United States
Minnesota Oncology Hematology, PA
Burnsville, Minnesota, United States
Allina Health Cancer Institute - Mercy Hospital
Coon Rapids, Minnesota, United States
Minnesota Oncology Hematology, PA
Coon Rapids, Minnesota, United States
Minnesota Oncology Hematology, P.A.
Edina, Minnesota, United States
Minnesota Oncology Hematology PA
Maple Grove, Minnesota, United States
Minnesota Oncology Hematology, P.A.
Maplewood, Minnesota, United States
Minnesota Oncology Hematology, P.A...
Minneapolis, Minnesota, United States
Allina Health Cancer Institute - Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Allina Health Cancer Institute - United Hospital
Saint Paul, Minnesota, United States
Minnesota Oncology Hematology, PA
Woodbury, Minnesota, United States
Missouri Cancer Associates
Columbia, Missouri, United States
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana
Billings, Montana, United States
Essex Oncology of North Jersey
Belleville, New Jersey, United States
CHRISTUS St. Vincent Regional Cancer Center
Santa Fe, New Mexico, United States
Christus St. Vincent Regional Medical Center
Santa Fe, New Mexico, United States
Montefiore Medical Center - Montefiore Medical Park
The Bronx, New York, United States
White Plains Hospital
White Plains, New York, United States
Oncology Hematology Care Inc
Cincinnati, Ohio, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
Oncology Hematology Care Inc
Cincinnati, Ohio, United States
Oncology Hematology Care Inc
Fairfield, Ohio, United States
Oncology Associates of Oregon, P.C.
Eugene, Oregon, United States
Alliance Cancer Specialists, PC
Bensalem, Pennsylvania, United States
Consultants in Medical Oncology and Hematology, P.C.
Broomall, Pennsylvania, United States
Alliance Cancer Specialists, PC
Doylestown, Pennsylvania, United States
Alliance Cancer Specialists, PC
Horsham, Pennsylvania, United States
Alliance Cancer Specialists, P.C.
Langhorne, Pennsylvania, United States
Alliance Cancer Specialists, PC
Media, Pennsylvania, United States
Alliance Cancer Specialists, PC
Sellersville, Pennsylvania, United States
Alliance Cancer Specialists, PC
Wynnewood, Pennsylvania, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Texas Oncology - West Texas
Abilene, Texas, United States
Texas Oncology-Northeast Texas
Allen, Texas, United States
Texas Oncology- Central South.
Austin, Texas, United States
Texas Oncology Central South
Austin, Texas, United States
Texas Oncology- Central South.
Austin, Texas, United States
Texas Oncology - Central South (Renfert Way)
Austin, Texas, United States
Texas Oncology - Gulf Coast
Beaumont, Texas, United States
The University of Texas, MD Anderson Cancer Center - Woodlands
Conroe, Texas, United States
Texas Oncology - Dallas (Sammons)
Dallas, Texas, United States
Texas Oncology-Northeast Texas
Denison, Texas, United States
Texas Oncology-Northeast Texas
Denton, Texas, United States
Texas Oncology-Northeast Texas
Flower Mound, Texas, United States
Texas Oncology- Central South
Harlingen, Texas, United States
The University of Texas MD Anderson Cancer Center Diagnostic Imaging
Houston, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
The University of Texas, MD Anderson Cancer Center- Interventional Radiology
Houston, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
The University of Texas MD Anderson Cancer Center Clinical Research Imaging
Houston, Texas, United States
The University of Texas, MD Anderson Cancer Center - West Houston
Houston, Texas, United States
US Oncology Investigational Product Center (IPC)
Irving, Texas, United States
US Oncology Investigational Products Center (IPC)
Irving, Texas, United States
US Oncology Investigational Products Center(IPC)
Irving, Texas, United States
The University of Texas, MD Anderson Cancer Center - League City
League City, Texas, United States
Texas Oncology-Northeast Texas
Lewisville, Texas, United States
Texas Oncology-Northeast Texas
Longview, Texas, United States
Texas Oncology
McAllen, Texas, United States
Texas Oncology-Northeast Texas
McKinney, Texas, United States
Texas Oncology-Northeast Texas
Palestine, Texas, United States
Texas Oncology-Northeast Texas
Paris, Texas, United States
Texas Oncology - Gulf Coast
Pearland, Texas, United States
Baylor Scott & White Health - Round Rock
Round Rock, Texas, United States
The University of Texas, MD Anderson Cancer Center - Sugar Land
Sugar Land, Texas, United States
Texas Oncology - Gulf Coast
Sugar Land, Texas, United States
Texas Oncology - Gulf Coast
The Woodlands, Texas, United States
Texas Oncology-Northeast Texas
Tyler, Texas, United States
Texas Oncology- Central South
Waco, Texas, United States
Texas Oncology-Central South
Waco, Texas, United States
Texas Oncology - Central South
Weslaco, Texas, United States
Blue Ridge Cancer Care
Blacksburg, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia Inc dba Blue Ridge Cancer Care
Salem, Virginia, United States
Shenandoah Oncology, P.C.
Winchester, Virginia, United States
American Oncology Network Vista Oncology Division-West office
Olympia, Washington, United States
American Oncology Network Vista Oncology Division-East office
Olympia, Washington, United States
Fundación Respirar
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
Grampians Health
Ballarat, Victoria, Australia
AZ Sint-Maarten
Mechelen, Antwerpen, Belgium
Grand Hôpital de Charleroi -
Charleroi, Hainaut, Belgium
Jessa Ziekenhuis
Hasselt, Limburg, Belgium
Algemeen Ziekenhuis klina
Brasschaat, Belgium
MBAL Uni Hospital
Panagyurishte, Pazardzhik, Bulgaria
Specialized Hospital for Active Treatment of Oncology - Haskovo
Haskovo, Bulgaria
MHAT for Women's Health Nadezhda
Sofia, Bulgaria
Trakia Hospital
Stara Zagora, Bulgaria
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Lakeridge Health
Oshawa, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre
Greenfield Park, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Centre de Services Ambulatoire de St-Jerome
Saint-Jérôme, Quebec, Canada
Unité de Recherche Clinique du CISSS des Laurentides
Saint-Jérôme, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
Québec, Canada
IUCPQ-Universite Laval
Québec, Canada
Anhui Provincial Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Friendship Hospital Affiliate of Capital University
Beijing, Beijing Municipality, China
Beijing Cancer hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Jinan Central Hospital
Jinan, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Yunnan Province Cancer Hospital
Kunming, Yunnan, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Henan Cancer Hospital
Zhengzhou, China
Nemocnice AGEL Ostrava - Vítkovice a.s. Plicní ambulance - pneumoonkologická ambulance
Ostrava, Ostrava Město, Czechia
Nemocnice AGEL Novy Jicin a.s.
Nový Jičín, Czechia
Fakultni nemocnice Olomouc
Olomouc, Czechia
Fakultni nemocnice Motol a Homolka
Prague, Czechia
Rigshospitalet Department of Oncology
Copenhagen, Capital Region, Denmark
Roskilde Sygehus
Roskilde, Region Sjælland, Denmark
Odense Universitetshospital
Odense, Region Syddanmark, Denmark
Aarhus Universitetshospital
Aarhus, Denmark
Kuopion Yliopistollinen Sairaala
Kuopio, Northern Savonia, Finland
Vaasan Keskussairaala
Vaasa, Pohjanmaa, Finland
Turku University Hospital
Turku, Southwest Finland, Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
Helsinki, Uusimaa, Finland
Centre Hospitalier Universitaire Cavale Blanche
Brest, Brittany Region, France
Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
Brest, Finistère, France
CHU de Toulouse - Hopital Larrey
Toulouse, Haute-garonne, France
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
Rennes, Ille-et-vilaine, France
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes
Saint-Herblain, Loire-atlantique, France
CHU Lille - Institut Coeur Poumon
Lille, NORD, France
Gustave Roussy
Villejuif, Val-de-marne, France
Institut Bergonié
Bordeaux, France
Hopital Cochin
Paris, France
Institut Curie
Paris, France
Hôpital Tenon
Paris, France
Krankenhaus Nordwest GmbH
Frankfurt am Main, Hesse, Germany
Lungenfachklinik Immenhausen
Immenhausen, Hesse, Germany
InVO Institut für Versorgungsforschung in der Onkologie
Koblenz, Rhineland-Palatinate, Germany
Vivantes Auguste-Viktoria-Klinikum
Berlin, Germany
Universitaetsklinikum Jena
Jena, Germany
Central Apotheke
Steinbach, Germany
Agios Loukas Clinic
Thessaloniki, Thessaloníki, Greece
European Interbalkan Medical Center
Thessaloniki, Thessaloníki, Greece
University General Hospital of Larissa
Larissa, Thessalía, Greece
?enry Dunant Hospital Center Fourth Department of Oncology and Clinical Trials Unit
Athens, Greece
Sahyadri Super Speciality Hospital
Pune, Maharashtra, India
Rajiv Gandhi Cancer Institute And Research Centre
New Delhi, National Capital Territory of Delhi, India
Apollo Multispeciality Hospitals limited
Kolkata, West Bengal, India
Fortis Hospital
Delhi, India
Caritas Hospital
Kerala, India
Rabin Medical Center
Petah Tikva, Central District, Israel
Sheba Medical Center
Ramat Gan, Central District, Israel
Yitzhak Shamir Medical Center
Ẕerifin, Central District, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalem, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, Israel
Sourasky Medical Center
Tel Aviv, TELL ABĪB, Israel
Cro-Irccs
Aviano, Pordenone, Italy
Istituto Nazionale Tumori Regina Elena
Rome, ROMA, Italy
Ospedale Isola Tiberina Gemelli Isola
Roma, ROME, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, Veneto, Italy
Cliniche Gavazzeni S.p.A. - Humanitas Gavazzeni
Bergamo, Italy
AORN Sant'Anna e San Sebastiano
Caserta, Italy
Istituto Europeo di Oncologia IRCCS
Milan, Italy
Ausl Della Romagna- Ospedale Santa Maria Delle Croci Ravenna
Ravenna, Italy
Kurume University Hospital
Kurume, Fukuoka, Japan
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Kure, Hiroshima, Japan
Hyogo Cancer Center
Akashi, Hyōgo, Japan
National Hospital Organization Kochi National Hospital
Kochi, Kochi, Japan
Mie Chuo Medical Center
Tsu, Mie-ken, Japan
Sendai Kousei Hospital
Sendai, Miyagi, Japan
National Hospital Organization Nagasaki Medical Center
Ōmura, Nagasaki, Japan
National Hospital Organization Beppu Medical Center
Beppu-shi, Oita Prefecture, Japan
Kindai University Hospital
Sakai, Osaka, Japan
NHO Kinki Chuo Chest Medical Center
Sakai, Osaka, Japan
The University of Osaka Hospital
Suita, Osaka, Japan
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, Japan
National Hospital Organization Tokyo National Hospital
Kiyose, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan
National Hospital Organization Kyoto Medical Center
Kyoto, Japan
National Hospital Organization Okayama Medical Center
Okayama, Japan
Osaka International Cancer Institute
Osaka, Japan
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, Oaxaca, Mexico
Clinica Integral Internacional de Oncolgia S. de R.L. de C.V ú Oncocenter
Puebla City, Mexico
St. Antonius Ziekenhuis, locatie Utrecht
Utrecht, Netherlands
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
Krakow, Lesser Poland Voivodeship, Poland
Instytut Genetyki i Immunologii GENIM
Lublin, Lublin Voivodeship, Poland
Provita Centrum Medyczne Spółka Z Ograniczoną Odpowiedzialnością, Provita Prolife
Tomaszów Mazowiecki, Poland
Instytut MSF Sp zoo
Lodz, Łódź Voivodeship, Poland
Ad-Vance Medical Research
Ponce, Puerto Rico
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
Bratislava, Slovakia
Narodny onkologicky ustav
Bratislava, Slovakia
Nemocnica s poliklinikou Stefana Kukuru Michalovce, a.s.
Michalovce, Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky
Nové Zámky, Slovakia
The Oncology Centre
Durban, KwaZulu-Natal, South Africa
Chungbuk National University Hospital
Cheongju-si, Chungcheongbuk-do [chungbuk], South Korea
National Cancer Center
Goyang-si, Kyǒnggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, Kyǒnggi-do, South Korea
The Catholic University Of Korea St. Vincent's Hospital
Suwon, Kyǒnggi-do, South Korea
Inje University Haeundae Paik Hospital
Haeundae-gu, Pusan-kwangyǒkshi, South Korea
Boramae Medical Center
Dongjak-gu, Seoul-teukbyeolsi [seoul], South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña [LA Coruña], Spain
Institut Català d'Oncologia (ICO) - Badalona
Badalona, Barcelona [barcelona], Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [cataluña], Spain
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario de Badajoz
Badajoz, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario San Cecilio
Granada, Spain
Hospital Universitari Son Espases
Palma, Spain
Hospital Universitario Virgen de Valme
Seville, Spain
Hospital General Universitario de Valencia
Valencia, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
Sjukhuset I Gävle
Gävle, Gävleborgs LÄN [se-21], Sweden
Mälarsjukhuset
Eskilstuna, Södermanlands LÄN [se-04], Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götalands LÄN [se-14], Sweden
Changhua Christian Hospital
Changhua County, Changhua, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
St Bartholomew's Hospital
London, London, CITY of, United Kingdom
Sarah Cannon Research Institute UK
London, London, CITY of, United Kingdom
Barts Health NHS Trust , The Royal London Hospital
London, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom