AzTrials
AzTrials

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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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
Are there results?
Not yet: the study is under way

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:
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  • 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
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  • 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

Other trials in United States

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

Other trials in China

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

Other trials in Italy

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

Other trials in Japan

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

Other trials in France

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

Other trials in Spain

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

Other trials in Canada

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

Other trials in United Kingdom

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

Other trials in Switzerland

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

Other trials in Brazil

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

Other trials in Germany

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

Other trials in Greece

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

Other trials in Romania

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

Other trials in Argentina

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

Other trials in Australia

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

Other trials in Belgium

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

Other trials in Israel

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

Other trials in Taiwan

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

Other trials in Poland

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

Other trials in Austria

Netherlands3 sites

  • Martini Ziekenhuis

    Groningen, 9728 NT

  • Maastricht UMC

    Maastricht, 6229 HX

  • Erasmus Medisch Centrum Daniel Den Hoed

    Rotterdam, 3015 GD

Other trials in Netherlands

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

Other trials in Norway

Chile2 sites

  • Centro de Investigacion Clinica Bradford Hill

    Recoleta, Santiago Metropolitan

  • CeCim Biocinetic

    Santiago, Santiago Metropolitan, 8331143

Other trials in Chile

Czechia2 sites

  • Nemocnice AGEL Ostrava Vitkovice a.s.,

    Ostrava, 70300

  • Vseobecna Fakultni Nemocnice v Praze

    Prague, 128 08

Other trials in Czechia

South Korea2 sites

  • Ajou University Hospital.

    Suwon, Gyeonggi-do, 16499

  • St. Vincent's Hospital, The Catholic University of Korea.

    Suwon, Gyeonggido [kyonggi-do], 16247

Other trials in South Korea

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.

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 groups in NCT06012435
Study groupRoleWhat they receive
Experimental ArmExperimentalsigvotatug vedotin monotherapy
Receives: Drug: sigvotatug vedotin
Control ArmActive comparatorDocetaxel monotherapy
Receives: Drug: docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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.

  1. First posted25 Aug 2023
  2. Study start21 Feb 2024
  3. Primary completion18 May 2026
  4. Study completion17 May 2028 (estimated)

Resources

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)
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.

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 331 sites in United States, China, Italy, Japan, France and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) between the experimental arm (sigvotatug vedotin) and control arm (docetaxel) (time frame: Approximately 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06012435.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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