Carcinoma, Non-Small-Cell LungPhase 3NCT06012435
A Study of SGN-B6A Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer
A Phase 3 study testing sigvotatug vedotin and docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by Seagen, a wholly owned subsidiary of Pfizer at 331 sites in 25 countries.
Trial summary
This clinical trial is studying nonsquamous non-small cell lung cancer (NSCLC). Participants in this study must have cancer that has spread through their body or can't be removed with surgery. Participants in this study must have been treated with no more than a platinum-based chemotherapy and an anti-PD-(L)1 drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- sigvotatug vedotin and docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 762 participants
- Where
- 331 sitesin 25 countries
- Study dates
- 21 Feb 2024to 17 May 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of locally advanced, unresectable (Stage IIIB, IIIC), or metastatic Stage IV (M1a, M1b, or M1c) NSCLC American Joint Committee on Cancer (AJCC) Staging Manual, Version 8.0, and the Union for International Cancer Control (UICC) Staging System (Eighth edition).
- Participants must have NSCLC with nonsquamous histology
- Tumors with squamous, or predominantly squamous histology are excluded.
- Tumors with small cell elements are excluded.
- Participants who have NSCLC with known actionable genomic alteration (AGAs) are permitted
- Participants must have received the following prior therapies and progressed during or relapsed after receiving their most recent prior therapy:
Show all 15Show fewer
- 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 a PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy), unless contraindicated.
- Experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant or neoadjuvant setting and received a PD-(L)1 monoclonal antibody at any time during the course of treatment.
- Participants with known AGAs must fulfill the following conditions:
- Must have received at least 1 relevant AGA targeted therapy 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 or neoadjuvant setting
- May have received up to 1 PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy).
- Measurable disease based on RECIST v1.1
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with adequate baseline hematologic, hepatic, and renal function and measurable disease according to RECIST v1.1
Who cannot join
- Life expectancy of less than (<) 3 months
- Known allergies/hypersensitivity/intolerance to or contraindication of taxanes, docetaxel, or any excipient contained in the drug formulation of sigvotatug vedotin
- History of another malignancy within 3 years before Cycle 1 Day 1, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death
- Participants with any of the following respiratory conditions:
- Evidence of noninfectious interstitial lung disease (ILD) or pneumonitis that:
- Was previous diagnosed and required systemic steroids, or
Show all 25Show fewer
- Is currently diagnosed and managed, or
- Is suspected on radiologic imaging at screening
- Known diffusing capacity of the lung for carbon monoxide (DLCO) < 50%
- Any Grade greater than or equal to (≥) 3 pulmonary disease unrelated to underlying malignancy
- Pre-existing peripheral neuropathy Grade greater than or equal to (≥) 2
- Uncontrolled diabetes mellitus
- Prior therapy:
- Prior treatment with antimicrotubule agents (taxanes, vinca alkaloids, or MMAEs) in the locally advanced, unresectable/refractory, or metastatic setting
- Prior antimicrotubule agent exposure in curative settings (including adjuvant, neoadjuvant, or chemoradiotherapy) is permissible.
- Received more than 1 prior line of cytotoxic chemotherapy in the locally advanced, unresectable/refractory, or metastatic setting
- Prior cytotoxic chemotherapy in curative settings is permissible
- At least 14 days must have elapsed from the last dose of radiotherapy until Cycle 1 Day 1.
- Prior radiation therapy to the lung parenchyma that is >30 Gray (Gy) within 6 months of Cycle 1 Day 1.
- Any systemic anticancer therapy (standard or experimental) within 21 days prior to Cycle 1 Day 1.
- Active central nervous system (CNS) lesions, including leptomeningeal metastasis, are excluded. Participants with definitively treated brain metastases are eligible in they meet the following criteria:
- Have been clinically stable for at least 4 weeks prior to treatment initiation and baseline scans show no evidence of new or enlarged metastasis
- On a stable dose of less than or equal to (≤) 10mg/day of prednisone or equivalent for a least 2 weeks (if requiring steroid treatment)
- Treatment with corticosteroids greater than (>) 1 month prior to Screening visit
- No evidence of clinical and radiographic disease progression in the CNS for ≥ 21 days after definitive radiotherapy and/or surgery
Trial locations and contacts
331 sites in 25 countries.
331 sites in 25 countries
United States130 sites
Texas Oncology - West Texas
Abilene, Texas, 79606
Texas Oncology - West Texas
Amarillo, Texas, 79124
Alaska Oncology and Hematology, LLC
Anchorage, Alaska, 99508
Maryland Oncology Hematology P.A.
Annapolis, Maryland, 21401
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005
Rocky Mountain Cancer Centers LLP
Aurora, Colorado, 80012
Texas Oncology - Central South
Austin, Texas, 78705
Texas Oncology - Central South
Austin, Texas, 78731
Texas Oncology - Central South
Austin, Texas, 78745
University Hospitals Seidman Cancer Center at UH Avon Health Center
Avon, Ohio, 44011
Oregon Health and Science University - CHO Beaverton
Beaverton, Oregon, 97006
Nebraska Medicine
Bellevue, Nebraska, 68123
Alliance Cancer Specialists, PC
Bensalem, Pennsylvania, 19020
Maryland Oncology Hematology P.A.
Bethesda, Maryland, 20817
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Blacksburg, Virginia, 24060
Northwest Medical Specialties, PLLC
Bonney Lake, Washington, 98391
Boston Medical Center
Boston, Massachusetts, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Rocky Mountain Cancer Centers LLP
Boulder, Colorado, 80303
Maryland Oncology Hematology P.A.
Brandywine, Maryland, 20613
Oncology Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, 45211
Oncology Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, 45242
Oncology Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, 45245
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic Cancer Center/Fairview Hospital Moll Cancer Pavilion
Cleveland, Ohio, 44111
Rocky Mountain Cancer Centers LLP
Colorado Springs, Colorado, 80907
Rocky Mountain Cancer Centers LLP
Colorado Springs, Colorado, 80923
Maryland Oncology Hematology P.A.
Columbia, Maryland, 21044
Allina Health Cancer Institute - Mercy Hospital
Coon Rapids, Minnesota, 55433
University of Texas Southwestern Medical Center - Simmons Cancer Center
Dallas, Texas, 75235
UT Southwestern Medical Center - Redbird
Dallas, Texas, 75237
Univ. of TX Southwestern Medical Center - Zale Lipshy University Hospital
Dallas, Texas, 75390
University of Texas Southwestern Medical Center - William P. Clements, Jr., University Hospital
Dallas, Texas, 75390
University Of Texas Southwestern Medical Center
Dallas, Texas, 75390
Rocky Mountain Cancer Centers LLP
Denver, Colorado, 80218
Rocky Mountain Cancer Centers LLP
Denver, Colorado, 80220
Alliance Cancer Specialists, PC
Doylestown, Pennsylvania, 18901
Texas Oncology - West Texas
El Paso, Texas, 79902
Texas Oncology - West Texas
El Paso, Texas, 79915
Texas Oncology - West Texas
El Paso, Texas, 79938
Oncology Associates of Oregon, P.C.
Eugene, Oregon, 97401
Oncology Hematology Care Clinical Trials, LLC
Fairfield, Ohio, 45014
Southcoast Centers for Cancer Care
Fairhaven, Massachusetts, 02719
Southcoast Centers for Cancer Care
Fall River, Massachusetts, 02720
Northwest Medical Specialties, PLLC
Federal Way, Washington, 98003
Cancer Specialists of North Florida
Fleming Island, Florida, 32003
Summit Medical Group
Florham Park, New Jersey, 07932
UT Southwestern - Simmons Cancer Center - Fort Worth
Fort Worth, Texas, 76104
Providence Medical Foundation
Fullerton, California, 92835
Providence St. Jude Medical Center Virginia K. Crosson Cancer Center and Infusion Center
Fullerton, California, 92835
Providence St. Jude Medical Center
Fullerton, California, 92835
Maryland Oncology Hematology P.A.
Germantown, Maryland, 20876
Northwest Medical Specialties, PLLC
Gig Harbor, Washington, 98332
Oregon Health and Science University - CHO Gresham
Gresham, Oregon, 97030
Hattiesburg Clinic Hematology/Oncology.
Hattiesburg, Mississippi, 39401
Alliance Cancer Specialists, PC
Horsham, Pennsylvania, 19044
US Oncology Investigational Product Center (IPC)
Irving, Texas, 75063
US Oncology Investigational Products Center (IPC)
Irving, Texas, 75063
Cancer Specialists of North Florida
Jacksonville, Florida, 32204
Cancer Specialists of North Florida
Jacksonville, Florida, 32218
Cancer Specialists of North Florida
Jacksonville, Florida, 32256
Cancer Specialists of North Florida
Jacksonville, Florida, 32258
St Luke's Cancer Institute
Kansas City, Missouri, 64111
Rocky Mountain Cancer Centers LLP
Lakewood, Colorado, 80228
Alliance Cancer Specialists, PC
Langhorne, Pennsylvania, 19047
Maryland Oncology Hematology P.A.
Largo, Maryland, 20774
Rocky Mountain Cancer Centers LLP
Littleton, Colorado, 80120
Rocky Mountain Cancer Centers LLP
Lone Tree, Colorado, 80124
Rocky Mountain Cancer Centers LLP
Longmont, Colorado, 80504
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720
Cancer Blood and Specialty Clinic
Los Alamitos, California, 90720
Regulatory Management Only: TRIO-US Central Administration
Los Angeles, California, 90024
Drug Management Only: UCLA West Medical Pharmacy Attn: Steven L. Wong, Pharma.D.
Los Angeles, California, 90095
Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L Wong, Pharm.D.
Los Angeles, California, 90095
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Low Moor, Virginia, 24457
Taylor Cancer Research Center
Maumee, Ohio, 43537
Cleveland Clinic Cancer Center/Hillcrest Hospital Cancer Center Pharmacy
Mayfield Heights, Ohio, 44124
Alliance Cancer Specialists, PC
Media, Pennsylvania, 19063
Cancer Care Centers of Brevard, Inc.
Melbourne, Florida, 32935
University Hospitals Seidman Cancer Center at UH Mentor Health Center
Mentor, Ohio, 44060
Baptist Hospital of Miami
Miami, Florida, 33176
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
Texas Oncology - West Texas
Midland, Texas, 79701
Froedtert Hospital/Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
NYU Langone Hospital - Long Island
Mineola, New York, 11501
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, 11501
Allina Health Cancer Institute - Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Cancer Specialists of North Florida
Neptune Beach, Florida, 32266
Laura & Isaac Perlmutter Cancer Center - NYU ACC
New York, New York, 10016
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
NYU Langone Medical Center (Tisch Hospital)
New York, New York, 10016
Illinois Cancer Specialists
Niles, Illinois, 60714
Texas Oncology - West Texas
Odessa, Texas, 79761
American Oncology Network Vista Oncology Division-West office
Olympia, Washington, 98502
American Oncology Network Vista Oncology Division
Olympia, Washington, 98506
Nebraska Medicine
Omaha, Nebraska, 68105
Nebraska Medicine
Omaha, Nebraska, 68118
University of Nebraska Medical Center
Omaha, Nebraska, 68198
UH Minoff Health Center at Chagrin Highlands
Orange, Ohio, 44122
Cancer Care Centers of Brevard, Inc.
Palm Bay, Florida, 32901
Oregon Health and Science University - CHO Northwest
Portland, Oregon, 97210
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97213
Oregon Health and Science University - CHO East Portland
Portland, Oregon, 97216
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97227
Oregon Health and Science University (CHH1)
Portland, Oregon, 97239
Oregon Health and Science University (CHH2)
Portland, Oregon, 97239
Oregon Health and Science University
Portland, Oregon, 97239
Rocky Mountain Cancer Centers LLP
Pueblo, Colorado, 81003
Northwest Medical Specialties, PLLC
Puyallup, Washington, 98373
UT Southwestern - Simmons Cancer Center - Richardson/Plano
Richardson, Texas, 75080
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Roanoke, Virginia, 24014
Cancer Care Centers of Brevard, Inc.
Rockledge, Florida, 32955
Maryland Oncology Hematology P.A.
Rockville, Maryland, 20850
Cancer Specialists of North Florida
Saint Augustine, Florida, 32086
Allina Health Cancer Institute - United Hospital
Saint Paul, Minnesota, 55102
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Salem, Virginia, 24153
UCSF Medical Center - Mission Bay
San Francisco, California, 94158
Sansum Clinic
Santa Barbara, California, 93105
Alliance Cancer Specialists, PC
Sellersville, Pennsylvania, 18960
Maryland Oncology Hematology P.A.
Silver Spring, Maryland, 20904
Sansum Clinic
Solvang, California, 93463
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405
Rocky Mountain Cancer Centers LLP
Thornton, Colorado, 80260
Northwest Cancer Specialists, P.C.
Tigard, Oregon, 97223
Oregon Health and Science University - CHO Tualatin
Tualatin, Oregon, 97062
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684
Texas Oncology - Central South
Waco, Texas, 76712
Texas Oncology - West Texas
Wichita Falls, Texas, 76310
Alliance Cancer Specialists, PC
Wynnewood, Pennsylvania, 19096
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Wytheville, Virginia, 24382
China29 sites
Beijing Cancer Hospital
Beijing, 100142
Beijing Chest Hospital, Capital Medical University
Beijing, 101149
Jilin Cancer Hospital
Changchun, Jilin, 130012
Hunan Cancer Hospital
Changsha, Hunan, 410013
Sichuan Province Cancer Hospital
Chengdu, Sichuan, 610213
Chongqing University Cancer Hospital
Chongqing, 400030
The First People's Hospital of Foshan
Foshan, Guangdong, 528000
Fujian provincial Cancer Hospital
Fuzhou, Fujian, 350014
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000
Shandong Cancer Hospital
Jinan, Shandong, 250117
LinYi Cancer Hospital
Linyi, Shandong, 276034
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan, 471000
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330200
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530021
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530201
Fudan University Shanghai Cancer Center
Shanghai, 200032
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317000
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430048
First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shannxi, 710061
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Italy17 sites
Azienda Ospedaliero Universitaria delle Marche
Ancona, 60126
Centro di Riferimento Oncologico (CRO) IRCCS
Aviano (PN), 33081
Azienda Ospedaliera Spedali Civili di brescia
Brescia, Province OF Brescia, 25123
AORN Sant'Anna e San Sebastiano
Caserta, 81100
A.O.U Policlinico G. Rodolico S. Marco
Catania, 95123
IRCCS Azienda Ospedaliera Metropolitana (AOM)
Genova, Other, 16132
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l
Meldola (Fc), Emilia-Romagna, 47014
Fondazione IRCCS Istituto Nazionale Dei Tumori
Milan, Lombardy, 20133
IRCCS Ospedale San Raffaele
Milan, 20132
U.O.C. Centro di Ricerca di Fase 1, Fondazione IRCCS San Gerardo dei Tintori
Monza, MB, 20900
U.O.C. Oncologia Medica, Fondazione IRCCS San Gerardo dei Tintori
Monza, MB, 20900
UOC Oncologia Medica - Azienda Ospedaliero - Universitaria di Parma
Parma, 43126
Farmacia
Roma, ROME, 00144
IRCCS Istituto Nazionale dei Tumori Regina Elena
Roma, ROME, 00144
Fondazione Policlinico Gemelli
Roma, 00168
Radiologia
Rome, 53-00144
Sperimentazioni cliniche fase 1
Rome, 53-00144
Japan17 sites
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, 113-8603
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyo-ku, Tokyo, 113-8677
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577
Kobe City Hospital Organization Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550
Kurume University Hospital
Kurume, Fukuoka, 830-0011
NHO Shikoku Cancer Center
Matsuyama, Ehime, 791-0280
Aichi Cancer Center
Nagoya, Aichi-ken, 464-8681
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566
Osaka International Cancer Institute
Osaka, Other, 541-8567
Gunma Prefectural Cancer Center
Ota-Shi, Gunma, 373-8550
Kindai University Hospital
Sakai, Osaka, 590-0197
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777
Osaka Medical and Pharmaceutical University Hospital
Takatsuki-shi, Osaka, 569-8686
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515
France16 sites
CHU de Besancon - Hopital Jean Minjoz
Besançon, 25030
Centre Hospitalier de Cholet
Cholet, 49300
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010
CHRU de Lille
Lille, 59037
Hopital Nord - Batiment Mistral
Marseille, 13015
Centre de Cancerologie du Grand Montpellier
Montpellier, 34070
Service UPCC, R-1, Clinique Clementville
Montpellier, 34070
Hopital Cochin, APHP Centre Universite de Paris
Paris, 75014
Hopital Bichat-Claude Bernard
Paris, 75018
CHU de Bordeaux, Hopital du Haut-Leveque, Centre Francois Magendie
Pessac, 33604
CH de Cornouaille
Quimper, 29000
CHU de Rennes - Hôpital Pontchaillou
Rennes, 35033
Centre de Lutte contre le Cancer Paul Strauss - CPS
Strasbourg, 67033
Hopital Sainte Musse
Toulon, 83000
CHU Toulouse - Hopital Larrey
Toulouse, 31059
IGR Gustave Roussy
Villejuif, 94805
Spain16 sites
Complejo Hospitalario Universitario La Coruna
A Coruña, Galicia, 15006
Hospital General Universitario Alicante
Alicante, Valencia, 03010
Hospital General Universitario de Alicante - Farmacia
Alicante, 03010
lnstitut Catala D'oncologia (ICO) Badalona - Hospital Universitari Germans Trias I Pujol
Badalona, 08919
CETIR Viladomat
Barcelona, Other, 08029
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Consorcio Hospitalario Provincial de Castellon
Castellon, 12002
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Hospital Clinico San Carlos
Madrid, 28040
Servicio de Farmacia Hospitalaria
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Quironsalud Malaga
Málaga, 129004
Hospital Universitario Son Espases
Palma, Balearic Islands, 07120
Fundación Instituto Valenciano de Oncología (FIVO)
Valencia, 46009
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Hospital Clinico Universitario Lozano Blesa de Zaragoza
Zaragoza, 50009
Canada12 sites
William Osler Health System - Brampton Civic Hospital.
Brampton, Ontario, L6R 3J7
William Osler Health System - Peel Memorial Hospital
Brampton, Ontario, L6W 2Z8
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
William Osler Health System - Etobicoke General Hospital
Etobicoke, Ontario, M9V 1 R8
CISSS de la Monteregie-Centre
Greenfield Park, Quebec, J4V 2H1
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 0A9
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 0C1
The Research Institute of the McGill University Health Centre
Montreal, Quebec, H3H 2R9
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
United Kingdom11 sites
J B Russell House, Gartnavel Royal Hospital
Glasgow, Scotland, G12 0XH
The Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Diagnostic Centre
London, Others, W1G 7AF
The Harley Street Clinic (THSC)
London, Other, W1G 8BJ
St. Bartholomew's Hospital - Barts Health NHS Trust
London, EC 1A 7BE
The Royal Marsden NHS Foundation Trust (RM).
London, SW3 6JJ
Sarah Cannon Research Institute UK
London, W1G 6AD
The Harley Street Clinic
London, W1G 7LJ
The Harley Street Clinic
London, W1G 8PP
The Christie NHS Foundation Trust
Manchester, M20 4BX
Royal Marsden Hospital Sutton
Sutton, SM2 5PT
Switzerland9 sites
Universitatsspital Basel
Basel, 4031
Inselspital
Bern, 3010
Kantonsspital Graubuenden
Chur, Graubünden (DE), 7000
Kantonsspital Graubünden/Medizinische Onkologie und Hämatologie
Chur, Graubünden (DE), 7000
Kantonsspital Graubuenden
Chur, Other, 7000
University Hospital Lausanne CHUV
Lausanne, 1011
Universitatsspital Zurich, Institut fur diagnostische und interventionelle Radiologie
Zurich, 8091
Universitatsspital Zurich
Zurich, 8091
Universitatsspital Zurich
Zurich, CH-8091
Brazil8 sites
Hospital de Cancer de Barretos - Fundacao Pio XII
Barretos, São Paulo, 14748-400
Oncosite - Centro de Pesquisa Clinica e Oncologia
Ijuí, Rio Grande do Sul, 98700-000
Fundação Doutor Amaral Carvalho.
Jaú, São Paulo, 17210-080
União Brasileira de Educação e Assitência (UBEA), mantenedora do Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000
Hospital Mãe de Deus
Porto Alegre, 90110-270
Nucleo de Oncologia da Bahia - Oncoclinicas
Salvador, 40170-110
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
Santo André, São Paulo, 09060-650
Centro Paulista de Oncologia S A
Vila Olímpia, São Paulo, 04538-132
Germany7 sites
Johanniter Krankenhaus Bonn
Bonn, 53113
Klinikum Esslingen GmbH
Esslingen am Neckar, 73730
Universitätsklinikum Frankfurt
Frankfurt a.M., 60590
Asklepios Klinik Gauting GmbH
Gauting, 82131
LungenClinic Grosshansdorf
Großhansdorf, 22927
Krankenhaus Martha-Maria Halle-Dölau GmbH
Halle, Other, 06120
Thoraxklinik Heidelberg gGmbH
Heidelberg, D-69126
Greece7 sites
General Hospital of Athens Alexandra
Athens, Attikí, 11528
Henry Dunant Hospital Center
Athens, 11526
University General Hospital of Larisa
Larissa, 41110
Metropolitan Hospital
N.Faliro, 18547
General University Hospital of Patras
Pátrai, 26504
Interbalkan Medical Center
Pilea Thessaloniki, 555 35
St. Luke s Hospital
Thessaloniki, 55236
Romania7 sites
SC Policlinica CCBR SRL
Bucharest, Sector 3, 030463
Memorial Healthcare International S.R.L
Bucharest, 013823
S.C. Medisprof S.R.L
Cluj-Napoca, Cluj, 400641
Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj-Napoca
Cluj-Napoca, Koblenz, 400015
Centrul de Oncologie Sf Nectarie
Craiova, 200542
Ovidius Clinical Hospital
Ovidiu, Constanța County, 905900
S.C. Oncocenter Oncologie Clinica S.R.L, Sectia Oncologie Medicala
Timișoara, Timiș County, 300166
Argentina6 sites
CEMAIC - Centro Medico Privado
Córdoba, Cundinamarca, X5008HHW
Sanatorio Allende Cerro
Córdoba, X5021FPQ
Instituto de Investigaciones Clinicas de Mar del Plata
Mar del Plata, Buenos Aires, B7600FZO
Sanatorio Parque
Rosario, Santa Fe Province, S2000DSV
Hospital Provincial del Centenario
Rosario, Santa Fe Province, S2002KDS
Centro Oncologico de Excelencia
San Juan, J5400
Australia5 sites
Border Medical Oncology Research Unit
Albury, New South Wales, 2640
Peninsula Health, Frankston Hospital
Franskton, Victoria, 3199
The Alfred Hospital
Melbourne, Victoria, 3004
St John of God Hospital Murdoch
Murdoch, Western Australia, 6150
Calvary Mater Newcastle
Waratah, New South Wales, 2298
Belgium5 sites
Algemeen Ziekenhuis klina
Brasschaat, 2930
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Universitair Ziekenhuis Gent
Ghent, 9000
Jessa Ziekenhuis VZW
Hasselt, 3500
CHU de Liege
Liège, 4000
Israel5 sites
Shaare Zedek Medical Center
Jerusalem, 9103102
Meir Medical Center
Kfar Saba, 4428164
Rabin Medical Center
Petah Tikva, 4941492
Kaplan Medical Center
Rehovot, 7661041
Tel Aviv Sourasky Medical Center
Tel Aviv, Other, 6423906
Taiwan5 sites
Changhua Christian Medical Foundation Changhua Christian Hospital
Changhua, 500
National Taiwan University Hospital Yunlin Branch
Douliu, Yunlin, 640
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
E-Da Hospital
Kaohsiung City, 82445
Taipei Veterans General Hospital
Taipei, 11217
Poland4 sites
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214
Instytut MSF Sp. z.o.o.
Lodz, 90-302
Institute of Genetics and Immunology GENIM LCC
Lublin, 20-609
Med-Polonia Sp. z.o.o.
Poznan, 60-693
Austria3 sites
Anstaltsapotheke Wiener Gesundheitsverbund Universitatsklinikum AKH Wien
Vienna, 1090
Riedl-Prayer-Drahanowsky-Barton Radiologiegruppenpraxis OG (RPDB)- Imagingpraterstern
Vienna, A-1020
Medizinischen Universitat Wien, Universitatsklinik fur Innere Medizin I
Vienna
Netherlands3 sites
Martini Ziekenhuis
Groningen, 9728 NT
Maastricht UMC
Maastricht, 6229 HX
Erasmus Medisch Centrum Daniel Den Hoed
Rotterdam, 3015 GD
Norway3 sites
Vestre Viken Health Trust - Drammen Hospital
Drammen, 3004
Oslo University Hospital (OUH) - The Norwegian Radium Hospital
Oslo, 0379
Sykehusapoteket Oslo, Radiumhospitalet - Avdeling Produksjon
Oslo, 0379
Chile2 sites
Centro de Investigacion Clinica Bradford Hill
Recoleta, Santiago Metropolitan
CeCim Biocinetic
Santiago, Santiago Metropolitan, 8331143
Czechia2 sites
Nemocnice AGEL Ostrava Vitkovice a.s.,
Ostrava, 70300
Vseobecna Fakultni Nemocnice v Praze
Prague, 128 08
South Korea2 sites
Ajou University Hospital.
Suwon, Gyeonggi-do, 16499
St. Vincent's Hospital, The Catholic University of Korea.
Suwon, Gyeonggido [kyonggi-do], 16247
About this study
Official title: A RANDOMIZED, PHASE 3, OPEN-LABEL STUDY TO EVALUATE SIGVOTATUG VEDOTIN COMPARED WITH DOCETAXEL IN ADULT PARTICIPANTS WITH PREVIOUSLY TREATED NON-SMALL CELL LUNG CANCER (BE6A LUNG-01)
This clinical trial is studying nonsquamous non-small cell lung cancer (NSCLC). Participants in this study must have cancer that has spread through their body or can't be removed with surgery. Participants in this study must have been treated with no more than a platinum-based chemotherapy and an anti-PD-(L)1 drug. Participants with tumors that have certain treatable genomic alterations must have had at least 1 drug for that genomic alteration, in addition to platinum-based chemotherapy.
This clinical trial uses an experimental drug called sigvotatug vedotin, which is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. This clinical trial also uses a drug called docetaxel. Docetaxel is an anticancer drug that has been approved to treat non-small cell lung cancer. It is usually given to patients who previously received another anticancer treatment. In this study, one group of participants will get sigvotatug vedotin on Days 1 and 15 during each 28-day-cycle. A second group of participants will get docetaxel on Day 1 during each 21-day cycle.
This study is being done to see if sigvotatug vedotin works better than docetaxel to treat participants with NSCLC. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- sigvotatug vedotin, docetaxel
- Keywords
- Non-Small Lung Cancer, Seattle Genetics, lung cancer, advanced lung cancer, metastatic lung cancer, non small cell lung cancer, stage 3 lung cancer, stage 4 lung cancer, lung cancer treatment, lung cancer clinical trial, nonsquamous lung cancer, ADC, Pfizer cancer trial, vedotin, lung disease, phase 3 lung
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sigvotatug vedotinDrug
Also called SGN-B6A; PF-08046047
Given into the vein (IV; intravenously) on Day 1 and 15 of a 28-day cycle
docetaxelDrug
75 mg/m^2 given into the vein (IV; intravenously) on Day 1 of a 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | sigvotatug vedotin monotherapy Receives: Drug: sigvotatug vedotin |
| Control Arm | Active comparator | Docetaxel monotherapy Receives: Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS) between the experimental arm (sigvotatug vedotin) and control arm (docetaxel)
The time from date of randomization to date of death due to any cause.
Measured: Approximately 5 years
Secondary outcomes (19)
Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) as assessed by Blinded Independent Central Review (BICR)
The time from date of randomization to the first documented disease progression per RECIST v1.1 or to death due to any cause.
Measured: Approximately 5 years
PFS per RECIST v1.1 by investigator assessment
The time from date of randomization to the first documented disease progression per RECIST v1.1 or to death due to any cause.
Measured: Approximately 5 years
Confirmed Objective Response Rate (ORR) per RECIST v1.1 as assessed by BICR
The proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1.
Measured: Approximately 5 years
Confirmed ORR per RECIST v1.1 by investigator assessment
The proportion of participants with confirmed CR or PR according to RECIST v1.1.
Measured: Approximately 5 years
Duration of Response (DOR) per RECIST v1.1 by BICR
The time from the first documented objective response (CR or PR that is subsequently confirmed) to the first documented disease progression per RECIST v1.1 or to death due to any cause.
Measured: Approximately 5 years
DOR per RECIST v1.1 by investigator assessment
The time from the first documented objective response (CR or PR that is subsequently confirmed) to the first documented disease progression per RECIST v1.1 or to death due to any cause.
Measured: Approximately 5 years
Number of participants with adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Through 30 days after the last study intervention; Approximately 5 years
Mean score in the global health status/QoL combined score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
The EORTC QLQ-C30 was developed as a quantitative measure of health-related quality of life (HRQoL). Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: Approximately 5 years
Change from baseline in global health status/QoL combined score on the EORTC QLQ-C30
The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: Approximately 5 years
Mean score in physical functioning scores on the EORTC QLQ-C30
The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: Approximately 5 years
Change from baseline score in physical functioning scores on the EORTC QLQ-C30
The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: Approximately 5 years
Mean score in role functioning scores on the EORTC QLQ-C30
The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: Approximately 5 years
Change from baseline score in role functioning scores on the EORTC QLQ-C30
The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: Approximately 5 years
Mean scores in the dyspnea, cough, and chest pain scores on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13)
The EORTC QLQ-LC13 is a lung-cancer specific module that serves as an additional 13 item questionnaire to the general EORTC cancer questionnaire. It incorporates 1 multi-item scale to assess dyspnea, and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Scores range from 0 to 100. A high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: Approximately 5 years
Change from baseline in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13
The EORTC QLQ-LC13 is a lung-cancer specific module that serves as an additional 13 item questionnaire to the general EORTC cancer questionnaire. It incorporates 1 multi-item scale to assess dyspnea, and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Scores range from 0 to 100. A high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: Approximately 5 years
Time to Deterioration (TTD) in the global health status/QoL combined score on the EORTC QLQ-C30
TTD is defined as the time from date of randomization to first onset of PRO deterioration with or without subsequent confirmation. The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: Approximately 5 years
TTD in physical functioning scores on the EORTC QLQ-C30
TTD is defined as the time from date of randomization to first onset of PRO deterioration with or without subsequent confirmation. The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: Approximately 5 years
TTD in role functioning scores on the EORTC QLQ-C30
TTD is defined as the time from date of randomization to first onset of PRO deterioration with or without subsequent confirmation. The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: Approximately 5 years
TTD in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13
TTD is defined as the time from date of randomization to first onset of PRO deterioration with or without subsequent confirmation. The EORTC QLQ-LC13 is a lung-cancer specific module that serves as an additional 13 item questionnaire to the general EORTC cancer questionnaire. It incorporates 1 multi-item scale to assess dyspnea, and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Scores range from 0 to 100. A high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: Approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start21 Feb 2024
- Primary completion18 May 2026
- Study completion17 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Seagen, a wholly owned subsidiary of PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 762 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012435
- Sponsor's protocol ID
- SGNB6A-002
- Other IDs
- C5751002, 2023-503827-25-01, 2023
- Status last verified
- Jul 2026
- First submitted
- 21 Aug 2023
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.