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)
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)
2 other identifiers
interventional
680
28 countries
305
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2025
Longer than P75 for phase_3
305 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2025
CompletedFirst Posted
Study publicly available on registry
August 27, 2025
CompletedStudy Start
First participant enrolled
September 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 10, 2032
April 21, 2026
April 1, 2026
2.4 years
August 20, 2025
April 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
Overall survival defined as the time from the date of randomization to the date of death due to any cause.
Approximately 5 years
Secondary Outcomes (15)
Progression Free Survival (PFS) assessed by blinded independent central review (BICR)
Approximately 5 years
Objective Response Rate as assessed by BICR
Approximately 5 years
Progression Free Survival as assessed by Investigator
Approximately 5 years
Objective Response Rate (ORR) as assessed by Investigator
Approximately 5 years
Duration of Response as assessed by BICR
Approximately 5 years
- +10 more secondary outcomes
Study Arms (2)
PF-08046054 monotherapy
EXPERIMENTALPF-08046054 monotherapy
Docetaxel monotherapy
ACTIVE COMPARATORDocetaxel monotherapy
Interventions
Antibody Drug Conjugate Participants will receive PF-08046054, administered as an IV infusion.
Participants will receive Docetaxel, administered as an IV infusion.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed diagnosis of NSCLC with locally advanced, unresectable Stage IIIB or IIIC not eligible for definitive chemoradiotherapy or metastatic (Stage IV: M1a, M1b, or M1c) disease per the American Joint Committee on Cancer (AJCC) Staging Manual, Version 8.0, and the Union for International Cancer Control (UICC) Staging System. Note: Participants with a neuroendocrine component or histology are not eligible.
- PD-L1 expression on ≥1% of tumor cells based on local immunohistochemistry (IHC) testing with an assay utilizing the anti-PD-L1 monoclonal antibody clones 22C3 or SP263.
- Participants who have NSCLC with known AGAs are permitted.
- Able to provide any of the following tumor tissues for biomarker analysis:
- Archival specimen (preferably collected within 12 months after the last anticancer therapy) (see laboratory manual for details); or
- De novo biopsy from a tumor lesion, if medically feasible.
- Participants must have received the following therapies and progressed during or relapsed after receiving their most recent prior therapy, or have been intolerant to their most recent therapy:
- Participants with no known AGAs must fulfill 1 of the following conditions:
- Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease, and unless contraindicated, a PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy).
- Experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant, neoadjuvant, or chemoradiotherapy setting and received a PD-(L)1 monoclonal antibody at any time during the course of treatment.
- Participants with known AGAs (eg, EGFR mutations, ALK translocations, or other relevant actionable mutations) must fulfill the following conditions:
- Must have received at least 1 relevant AGA-targeted therapy if locally available and, in the opinion of the investigator, additional AGA-targeted therapy is not in the best interest of the participant
- Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease, or experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant, neoadjuvant, or chemoradiotherapy setting.
- May have received PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy).
You may not qualify if:
- History of another malignancy within 3 years before the first dose of PF-08046054, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year overall survival \[OS\] ≥90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.
- Any central nervous system (CNS) lesions, unless definitively treated with CNS-directed local therapy (surgery and/or radiotherapy). Participants with definitively treated brain metastases are eligible if they meet the following criteria:
- The participant is on a stable dose of ≤10 mg/day of prednisone or equivalent for at least \>14 days prior to randomization (if requiring steroid treatment).
- No clinical or radiographic progression in the CNS following CNS-directed definitive radiotherapy and/or surgery.
- Time since CNS-directed treatment is ≥28 days prior to randomization.
- Participants with a history of leptomeningeal metastasis are excluded.
- Prior treatment with an anti-PD-L1 agent (where indicated per protocol) within 5 half-lives.
- Previous receipt of an MMAE-containing agent or prior docetaxel.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (305)
Alabama Oncology
Alabaster, Alabama, 35007, United States
Alabama Oncology
Bessemer, Alabama, 35022, United States
Alabama Oncology, Bruno Cancer Center
Birmingham, Alabama, 35205, United States
Alabama Oncology
Birmingham, Alabama, 35209, United States
Alabama Oncology
Birmingham, Alabama, 35211, United States
Alabama Oncology
Birmingham, Alabama, 35235, United States
Alabama Oncology
Birmingham, Alabama, 35243, United States
Southern Cancer Center
Daphne, Alabama, 36526, United States
Southern Cancer Center, PC
Foley, Alabama, 36535, United States
Alaska Oncology and Hematology
Anchorage, Alaska, 99508, United States
Highlands Oncology Group, PA
Fayetteville, Arkansas, 72703, United States
Highlands Oncology Group, PA
Rogers, Arkansas, 72758, United States
Highlands Oncology Group, PA
Springdale, Arkansas, 72762, United States
Highlands Oncology Group
Springdale, Arkansas, 72762, United States
Providence Medical Foundation
Fullerton, California, 92835, United States
Providence St. Jude Medical Center
Fullerton, California, 92835, United States
Rocky Mountain Cancer Centers,LLP
Denver, Colorado, 80218, United States
Medical Oncology Hematology Consultants, PA
Newark, Delaware, 19713, United States
Cancer Care Centers of Brevard, Inc.
Palm Bay, Florida, 32901, United States
Florida Cancer Affiliates - Panama City
Panama City, Florida, 32405, United States
Tennessee Oncology, PLLC - Dalton
Dalton, Georgia, 30720, United States
Tennessee Oncology, PLLC - Ringgold
Ringgold, Georgia, 30736, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005, United States
Illinois CancerCare- Bloomington
Bloomington, Illinois, 61704, United States
Illinois Cancer Specialists
Chicago, Illinois, 60631, United States
Illinois CancerCare Galesburg
Galesburg, Illinois, 61401, United States
Accellacare of Duly
Lisle, Illinois, 60532, United States
Illinois CancerCare-Ottawa-Fox River Cancer Center
Ottawa, Illinois, 61350, United States
Illinois CancerCare- Pekin
Pekin, Illinois, 61554, United States
Illinois Cancer Care
Peoria, Illinois, 61615, United States
Illinois CancerCare-Peru - Valley Regional Cancer Center
Peru, Illinois, 61354, United States
Illinois CancerCare - Washington
Washington, Illinois, 61571, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Maryland Oncology Hematology, P.A.
Annapolis, Maryland, 21401, United States
Maryland Oncology Hematology, P.A.
Bethesda, Maryland, 20817, United States
Maryland Oncology Hematology, PA
Brandywine, Maryland, 20613, United States
Maryland Oncology Hematology
Columbia, Maryland, 21044, United States
Maryland Oncology Hematology P.A.
Germantown, Maryland, 20876, United States
Maryland Oncology Hematology, P.A
Largo, Maryland, 20774, United States
Maryland Oncology Hematology PA
Rockville, Maryland, 20850, United States
Maryland Oncology Hematology, P.A.
Silver Spring, Maryland, 20904, United States
Minnesota Oncology Hematology, PA
Burnsville, Minnesota, 55337, United States
Allina Health Cancer Institute - Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Minnesota Oncology Hematology, PA
Coon Rapids, Minnesota, 55433, United States
Minnesota Oncology Hematology, P.A.
Edina, Minnesota, 55435, United States
Minnesota Oncology Hematology PA
Maple Grove, Minnesota, 55369, United States
Minnesota Oncology Hematology, P.A.
Maplewood, Minnesota, 55109, United States
Minnesota Oncology Hematology, P.A...
Minneapolis, Minnesota, 55404, United States
Allina Health Cancer Institute - Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Allina Health Cancer Institute - United Hospital
Saint Paul, Minnesota, 55102, United States
Minnesota Oncology Hematology, PA
Woodbury, Minnesota, 55125, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana
Billings, Montana, 59102, United States
Nebraska Medicine-Bellevue Medical Center
Bellevue, Nebraska, 68123, United States
Nebraska Medicine
Omaha, Nebraska, 68105, United States
Nebraska Medicine - Village Pointe
Omaha, Nebraska, 68118, United States
University Of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Essex Oncology of North Jersey
Belleville, New Jersey, 07109, United States
CHRISTUS St. Vincent Regional Cancer Center
Santa Fe, New Mexico, 87505, United States
Christus St. Vincent Regional Medical Center
Santa Fe, New Mexico, 87505, United States
Montefiore Medical Center - Montefiore Medical Park
The Bronx, New York, 10461, United States
White Plains Hospital
White Plains, New York, 10601, United States
Oncology Hematology Care Inc
Cincinnati, Ohio, 45211, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
Oncology Hematology Care Inc
Cincinnati, Ohio, 45245, United States
Oncology Hematology Care Inc
Fairfield, Ohio, 45014, United States
Oncology Associates of Oregon, P.C.
Eugene, Oregon, 97401, United States
Alliance Cancer Specialists, PC
Bensalem, Pennsylvania, 19020, United States
Consultants in Medical Oncology and Hematology, P.C.
Broomall, Pennsylvania, 19008, United States
Alliance Cancer Specialists, PC
Doylestown, Pennsylvania, 18901, United States
Alliance Cancer Specialists, PC
Horsham, Pennsylvania, 19044, United States
Alliance Cancer Specialists, P.C.
Langhorne, Pennsylvania, 19047, United States
Alliance Cancer Specialists, PC
Media, Pennsylvania, 19063, United States
Alliance Cancer Specialists, PC
Sellersville, Pennsylvania, 18960, United States
Alliance Cancer Specialists, PC
Wynnewood, Pennsylvania, 19096, United States
Tennessee Oncology, PLLC - Chattanooga Downtown
Chattanooga, Tennessee, 37403, United States
Tennessee Oncology, PLLC - Chattanooga Med Park II
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC - Chattanooga Memorial
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC - Investigational Drug Services/Supply Storage
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology, PLLC - Cleveland
Cleveland, Tennessee, 37311, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909, United States
Tennessee Oncology, PLLC - Lebanon
Lebanon, Tennessee, 37090, United States
Tennessee Oncology, PLLC - Mount Juliet
Mount Juliet, Tennessee, 37122, United States
Tennessee Oncology, PLLC - Murfreesboro
Murfreesboro, Tennessee, 37129, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC - Investigational Drug Services
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC - Nashville Elliston Place Plaza Medical Oncology & Hematology Clinic
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC - Nashville Saint Thomas West
Nashville, Tennessee, 37205, United States
Tennessee Oncology, PLLC - Shelbyville
Shelbyville, Tennessee, 37160, United States
Tennessee Oncology, PLLC - Smyrna
Smyrna, Tennessee, 37167, United States
Texas Oncology - West Texas
Abilene, Texas, 79606, United States
Texas Oncology-Northeast Texas
Allen, Texas, 75013, United States
Texas Oncology- Central South.
Austin, Texas, 78705, United States
Texas Oncology Central South
Austin, Texas, 78731, United States
Texas Oncology- Central South.
Austin, Texas, 78745, United States
Texas Oncology - Central South (Renfert Way)
Austin, Texas, 78758, United States
Texas Oncology - Gulf Coast
Beaumont, Texas, 77702, United States
The University of Texas, MD Anderson Cancer Center - Woodlands
Conroe, Texas, 77384, United States
Texas Oncology - Dallas (Sammons)
Dallas, Texas, 75246, United States
Texas Oncology-Northeast Texas
Denison, Texas, 75020, United States
Texas Oncology-Northeast Texas
Denton, Texas, 76201, United States
Texas Oncology-Northeast Texas
Flower Mound, Texas, 75028, United States
Texas Oncology- Central South
Harlingen, Texas, 78550, United States
The University of Texas MD Anderson Cancer Center Diagnostic Imaging
Houston, Texas, 77030, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
The University of Texas, MD Anderson Cancer Center- Interventional Radiology
Houston, Texas, 77030, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
The University of Texas MD Anderson Cancer Center Clinical Research Imaging
Houston, Texas, 77054, United States
The University of Texas, MD Anderson Cancer Center - West Houston
Houston, Texas, 77079, United States
US Oncology Investigational Product Center (IPC)
Irving, Texas, 75063, United States
US Oncology Investigational Products Center (IPC)
Irving, Texas, 75063, United States
US Oncology Investigational Products Center(IPC)
Irving, Texas, 75063, United States
The University of Texas, MD Anderson Cancer Center - League City
League City, Texas, 77573, United States
Texas Oncology-Northeast Texas
Lewisville, Texas, 75056, United States
Texas Oncology-Northeast Texas
Longview, Texas, 75601, United States
Texas Oncology
McAllen, Texas, 78503, United States
Texas Oncology-Northeast Texas
McKinney, Texas, 75071, United States
Texas Oncology-Northeast Texas
Palestine, Texas, 75801, United States
Texas Oncology-Northeast Texas
Paris, Texas, 75460, United States
Texas Oncology - Gulf Coast
Pearland, Texas, 77584, United States
Baylor Scott & White Health - Round Rock
Round Rock, Texas, 78665, United States
The University of Texas, MD Anderson Cancer Center - Sugar Land
Sugar Land, Texas, 77478, United States
Texas Oncology - Gulf Coast
Sugar Land, Texas, 77479, United States
Texas Oncology - Gulf Coast
The Woodlands, Texas, 77380, United States
Texas Oncology-Northeast Texas
Tyler, Texas, 75702, United States
Texas Oncology- Central South
Waco, Texas, 76712, United States
Texas Oncology-Central South
Waco, Texas, 76712, United States
Texas Oncology - Central South
Weslaco, Texas, 78596, United States
Blue Ridge Cancer Care
Blacksburg, Virginia, 24060, United States
Oncology & Hematology Associates of Southwest Virginia Inc dba Blue Ridge Cancer Care
Salem, Virginia, 24153, United States
Shenandoah Oncology, P.C.
Winchester, Virginia, 22601, United States
American Oncology Network Vista Oncology Division-West office
Olympia, Washington, 98502, United States
American Oncology Network Vista Oncology Division-East office
Olympia, Washington, 98506, United States
Fundación Respirar
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ABP, Argentina
Instituto Argentino de Diagnóstico y Tratamiento (IADT)
Buenos Aires, C1122AAL, Argentina
Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
Grampians Health
Ballarat, Victoria, 3350, Australia
AZ Sint-Maarten
Mechelen, Antwerpen, 2800, Belgium
Grand Hôpital de Charleroi -
Charleroi, Hainaut, 6060, Belgium
Jessa Ziekenhuis
Hasselt, Limburg, 3500, Belgium
Algemeen Ziekenhuis klina
Brasschaat, 2930, Belgium
MBAL Uni Hospital
Panagyurishte, Pazardzhik, 4500, Bulgaria
Specialized Hospital for Active Treatment of Oncology - Haskovo
Haskovo, 6300, Bulgaria
MHAT for Women's Health Nadezhda
Sofia, 1330, Bulgaria
Trakia Hospital
Stara Zagora, 6000, Bulgaria
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
Lakeridge Health
Oshawa, Ontario, L1G 2B9, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre
Greenfield Park, Quebec, J4V 2H1, Canada
Centre Intégré de Santé et de Services Sociaux (CISSS) de Laval / Hôpital de la Cité-de-la-Santé
Laval, Quebec, H7M 3L9, Canada
McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
Centre de Services Ambulatoire de St-Jerome
Saint-Jérôme, Quebec, J7Y 0L1, Canada
Unité de Recherche Clinique du CISSS des Laurentides
Saint-Jérôme, Quebec, J7Z 2V4, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
Québec, G1J 1Z4, Canada
IUCPQ-Universite Laval
Québec, G1V 4G5, Canada
Anhui Provincial Hospital
Hefei, Anhui, 230001, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
Beijing Friendship Hospital Affiliate of Capital University
Beijing, Beijing Municipality, 100050, China
Beijing Cancer hospital
Beijing, Beijing Municipality, 100142, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, 510515, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530021, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213003, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, 221006, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330200, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Jinan Central Hospital
Jinan, Shandong, 250013, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200123, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Yunnan Province Cancer Hospital
Kunming, Yunnan, 650118, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317000, China
Henan Cancer Hospital
Zhengzhou, 450008, China
Nemocnice AGEL Ostrava - Vítkovice a.s. Plicní ambulance - pneumoonkologická ambulance
Ostrava, Ostrava Město, 703 00, Czechia
Nemocnice AGEL Novy Jicin a.s.
Nový Jičín, 741 01, Czechia
Fakultni nemocnice Olomouc
Olomouc, 779 00, Czechia
Fakultni nemocnice Motol a Homolka
Prague, 150 00, Czechia
Rigshospitalet Department of Oncology
Copenhagen, Capital Region, 2100, Denmark
Roskilde Sygehus
Roskilde, Region Sjælland, 4000, Denmark
Odense Universitetshospital
Odense, Region Syddanmark, 5000, Denmark
Aarhus University Hospital
Aarhus N, 8200, Denmark
Kuopion Yliopistollinen Sairaala
Kuopio, Northern Savonia, 70210, Finland
Vaasan Keskussairaala
Vaasa, Pohjanmaa, 65130, Finland
Turku University Hospital
Turku, Southwest Finland, 20521, Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
Helsinki, Uusimaa, 00029, Finland
Centre Hospitalier Universitaire Cavale Blanche
Brest, Brittany Region, 29200, France
Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
Brest, Finistère, 29200, France
CHU de Toulouse - Hopital Larrey
Toulouse, Haute-garonne, 31059, France
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
Rennes, Ille-et-vilaine, 35033, France
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes
Saint-Herblain, Loire-atlantique, 44800, France
CHU Lille - Institut Coeur Poumon
Lille, NORD, 59037, France
Gustave Roussy
Villejuif, Val-de-marne, 94805, France
Institut Bergonié
Bordeaux, 33076, France
Assistance Publique Hôpitaux de Marseille - Hôpital Nord
Marseille, 13915, France
Hopital Cochin
Paris, 75014, France
Institut Curie
Paris, 75248, France
Hôpital Tenon
Paris, 75970, France
CHU de Rouen - Hôpital Charles Nicolle
Rouen, 76031, France
Krankenhaus Nordwest GmbH
Frankfurt am Main, Hesse, D-60488, Germany
Lungenfachklinik Immenhausen
Immenhausen, Hesse, 34376, Germany
Klinikum Kassel GmbH
Kassel, Hesse, 34125, Germany
InVO Institut für Versorgungsforschung in der Onkologie
Koblenz, Rhineland-Palatinate, 56068, Germany
Vivantes Auguste-Viktoria-Klinikum
Berlin, 12157, Germany
Universitaetsklinikum Jena
Jena, 07747, Germany
Central Apotheke
Steinbach, 61449, Germany
Agios Loukas Clinic
Thessaloniki, Thessaloníki, 552 36, Greece
European Interbalkan Medical Center
Thessaloniki, Thessaloníki, 570 01, Greece
University General Hospital of Larissa
Larissa, Thessalía, 41110, Greece
?enry Dunant Hospital Center Fourth Department of Oncology and Clinical Trials Unit
Athens, 115 26, Greece
Tata Memorial Hospital
Mumbai, Maharashtra, 400012, India
Sahyadri Super Speciality Hospital
Pune, Maharashtra, 411004, India
Rajiv Gandhi Cancer Institute And Research Centre
New Delhi, National Capital Territory of Delhi, 110085, India
Apollo Multispeciality Hospitals limited
Kolkata, West Bengal, 700054, India
Fortis Hospital
Delhi, 110088, India
Caritas Hospital
Kerala, 686630, India
Rabin Medical Center
Petah Tikva, Central District, 4941492, Israel
Sheba Medical Center
Ramat Gan, Central District, 5265601, Israel
Yitzhak Shamir Medical Center
Ẕerifin, Central District, 70300, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalem, 9013102, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, 9112001, Israel
Sourasky Medical Center
Tel Aviv, TELL ABĪB, 6423906, Israel
Cro-Irccs
Aviano, Pordenone, 33081, Italy
Istituto Nazionale Tumori Regina Elena
Rome, ROMA, 00144, Italy
Ospedale Isola Tiberina Gemelli Isola
Roma, ROME, 00186, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, Veneto, 37126, Italy
Cliniche Gavazzeni S.p.A. - Humanitas Gavazzeni
Bergamo, 24125, Italy
AORN Sant'Anna e San Sebastiano
Caserta, 81100, Italy
Istituto Europeo di Oncologia IRCCS
Milan, 20141, Italy
Ausl Della Romagna- Ospedale Santa Maria Delle Croci Ravenna
Ravenna, 48121, Italy
Kurume University Hospital
Kurume, Fukuoka, 830-0011, Japan
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Kure, Hiroshima, 737-0023, Japan
Hyogo Cancer Center
Akashi, Hyōgo, 673-8558, Japan
National Hospital Organization Kochi National Hospital
Kochi, Kochi, 780-8077, Japan
Mie Chuo Medical Center
Tsu, Mie-ken, 514-1101, Japan
Sendai Kousei Hospital
Sendai, Miyagi, 9810914, Japan
National Hospital Organization Nagasaki Medical Center
Ōmura, Nagasaki, 856-8562, Japan
National Hospital Organization Beppu Medical Center
Beppu-shi, Oita Prefecture, 874-0011, Japan
Kindai University Hospital
Sakai, Osaka, 590-0197, Japan
NHO Kinki Chuo Chest Medical Center
Sakai, Osaka, 591-8555, Japan
The University of Osaka Hospital
Suita, Osaka, 565-0871, Japan
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, 411-8777, Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, 113-8603, Japan
National Hospital Organization Tokyo National Hospital
Kiyose, Tokyo, 204-8585, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
National Hospital Organization Kyoto Medical Center
Kyoto, 612-8555, Japan
National Hospital Organization Okayama Medical Center
Okayama, 701-1192, Japan
Osaka International Cancer Institute
Osaka, 541-8567, Japan
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, Oaxaca, 68020, Mexico
Clinica Integral Internacional de Oncolgia S. de R.L. de C.V ú Oncocenter
Puebla City, 72530, Mexico
St. Antonius Ziekenhuis, locatie Utrecht
Utrecht, 3543 AZ, Netherlands
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
Krakow, Lesser Poland Voivodeship, 30-348, Poland
Instytut Genetyki i Immunologii GENIM
Lublin, Lublin Voivodeship, 20-609, Poland
Provita Centrum Medyczne Spółka Z Ograniczoną Odpowiedzialnością, Provita Prolife
Tomaszów Mazowiecki, 97-200, Poland
Instytut MSF Sp zoo
Lodz, Łódź Voivodeship, 90-302, Poland
Ad-Vance Medical Research
Ponce, 00717, Puerto Rico
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
Bratislava, 826 06, Slovakia
Narodny onkologicky ustav
Bratislava, 833 10, Slovakia
Nemocnica s poliklinikou Stefana Kukuru Michalovce, a.s.
Michalovce, 07101, Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky
Nové Zámky, 940 34, Slovakia
The Oncology Centre
Durban, KwaZulu-Natal, 4091, South Africa
Chungbuk National University Hospital
Cheongju-si, Chungcheongbuk-do [chungbuk], 28644, South Korea
National Cancer Center
Goyang-si, Kyǒnggi-do, 10408, South Korea
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, 13620, South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, Kyǒnggi-do, 13496, South Korea
The Catholic University Of Korea St. Vincent's Hospital
Suwon, Kyǒnggi-do, 16247, South Korea
Inje University Haeundae Paik Hospital
Haeundae-gu, Pusan-kwangyǒkshi, 48108, South Korea
Boramae Medical Center
Dongjak-gu, Seoul-teukbyeolsi [seoul], 07061, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], 03722, South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [seoul], 05505, South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], 06351, South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [seoul], 06591, South Korea
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña [LA Coruña], 15006, Spain
Institut Català d'Oncologia (ICO) - Badalona
Badalona, Barcelona [barcelona], 08916, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], 08035, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [cataluña], 08041, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, Comunidad de, 28009, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, 28041, Spain
Hospital Universitario de Badajoz
Badajoz, 06006, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Hospital Universitario San Cecilio
Granada, 18016, Spain
Hospital Universitari Son Espases
Palma, 07120, Spain
Hospital Universitario Virgen de Valme
Seville, 41014, Spain
Hospital General Universitario de Valencia
Valencia, 46014, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009, Spain
Sjukhuset I Gävle
Gävle, Gävleborgs LÄN [se-21], 80187, Sweden
Mälarsjukhuset
Eskilstuna, Södermanlands LÄN [se-04], 631 88, Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götalands LÄN [se-14], 413 45, Sweden
Changhua Christian Hospital
Changhua County, Changhua, 50006, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Taichung Veterans General Hospital
Taichung, 407219, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
St Bartholomew's Hospital
London, London, CITY of, EC1A 7BE, United Kingdom
Sarah Cannon Research Institute UK
London, London, CITY of, w1g 6ad, United Kingdom
Barts Health NHS Trust , The Royal London Hospital
London, E1 1FR, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2025
First Posted
August 27, 2025
Study Start
September 29, 2025
Primary Completion (Estimated)
March 10, 2028
Study Completion (Estimated)
March 10, 2032
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.