Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) (EVOKE-01)

Open-Label, Global, Multicenter, Randomized, Phase 3 Study of Sacituzumab Govitecan Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy

The goal of this clinical study is to compare the study drug, sacituzumab govitecan-hziy (SG), versus docetaxel in participants with advanced or metastatic (cancer that has spread) non-small cell lung cancer (NSCLC).

Study Overview

• Status: Active, not recruiting
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Docetaxel; Biological: Sacituzumab Govitecan-hziy (SG)

• Study Type: Interventional
• Enrollment (Actual): 603
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Albury, New South Wales, Australia, 2640
      • Border Medical Oncology Research Unit
    • Bowral, New South Wales, Australia, 2576
      • Southern Highlands Cancer Centre
    • Darlinghurst, New South Wales, Australia, 2010
      • St Vincent's Public Hospital
  • Queensland
    • Birtinya, Queensland, Australia, 4575
      • Sunshine Coast University Private Hospital
    • Greenslopes, Queensland, Australia, 4120
      • Gallipoli Medical Research Foundation
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Flinders Medical Centre
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Icon Cancer Centre
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Box Hill Hospital
    • Clayton, Victoria, Australia, 3168
      • Monash Health
    • Frankston, Victoria, Australia, 3199
      • Peninsula & South Eastern Haematology and Oncology Group
  • Western Australia
    • Joondalup, Western Australia, Australia, 6027
      • Joondalup Health Campus
    • Perth, Western Australia, Australia, 6009
      • ir Charles Gairdner Hospital
• Austria
  • Innsbruck, Austria, 06020
    • Medizinische Universität Innsbruck, Medizinische Universitat Innsbruck, Universitatsklinik fur Innere Medizin V, Hamatologie und Onkolgie
  • Salzburg, Austria, 5020
    • Muellner Hauptstrabe 48
  • Salzburg, Austria, A-5020
    • zuniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU
  • Vienna, Austria, 1210
    • Klinik Floridsdorf, Karl Landsteiner Institute fur Lungenforschung und Pneumologische onkologie (LFPO) Abteilung Fur Innere Medizin un Pneumologie
• Belgium
  • Brasschaat, Belgium, 2930
    • Algemeen Ziekenhuis Klina
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-luc
  • Edegem, Belgium, 2650
    • Universitair Ziekenhuis Antwerpen
  • Ghent, Belgium, 9000
    • Az Maria Middelares Ghent
  • Ghent, Belgium, 9000
    • Algemeen Ziekenhuis Sint-Lucas
  • Mons, Belgium, 7000
    • CHU Ambroise Pare
• Brazil
  • Fortaleza, Brazil, 60810180
    • Crio - Centro Regional Integrado de Oncologia
  • Ijuí, Brazil, 98700-000
    • ONCOSITE - Centro de Pesquisa Clinica em Oncologia
  • Itajaí, Brazil, 88331-10
    • Catatina Pesquisa Clinica - Clinica de Neoplasias Litoral
  • Jaú, Brazil, 17210080
    • Centro de Pesquisas Clínicas da Fundação Doutor Amaral Carvalho
  • Porto Alegre, Brazil, 90110-270
    • Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
  • Porto Alegre, Brazil, 90035903
    • Hospital de Clinicas de Porto Alegre - HCPA
  • São Paulo, Brazil
    • A Beneficência Portuguesa de São Paulo
  • São Paulo, Brazil, 03102002
    • Nucleo de Pesquisa da Rede Sao Camilo-Instituto Brasileiro de controle do cancer-IBC
  • São Paulo, Brazil
    • Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP
• Canada
  • Barrie, Canada, L4M 6M2
    • Royal Victoria Regional Health Centre
  • Brampton, Canada, L6R 3J7
    • William Osler Health System-Brampton Civic Hospital
  • Montreal, Canada, H4A 3J1
    • McGill University Health Centre
  • Rimouski, Canada, G5L5T1
    • Required Centre Hospitalier Regional de Rimouski
  • Windsor, Canada, N8W 2X3
    • Windsor Regional Hospital Cancer Program
• France
  • Avignon, France, 84918
    • Institut Sainte Catherine
  • Bayonne, France, 64100
    • Centre Hospitalier de la Cote Basque
  • Boulogne-Billancourt, France, 92100
    • APHP-Hopital Ambroise-Pare
  • Caen, France, 14033
    • CHU de Caen
  • Calvados, France, 14076 CEDEX 05
    • Centre Francois Baclesse
  • Chauny, France, 02300
    • Centre Hospitalier de Chauny
  • Clermont-Ferrand, France, 63000
    • CHU-Hopital Gabriel Montpied
  • Créteil, France, 94010
    • Centre Hospitalier Intercommunal de Créteil
  • Epagny Metz-tessy, France, 74374
    • Centre Hospitalier Annecy Genevois
  • La Roche-sur-Yon, France, 85925
    • Centre Hospitalier Departemental Vendee
  • Le Mans, France, 72000
    • Clinique Victor Hugo
  • Lille, France, 59000
    • CHU de LILLE
  • Limoges, France, 87042
    • Hopital Dupuytren (CHU de Limoges)
  • Montpellier, France, 34295 CEDEX
    • CHU Montpellier Hôpital Arnaud de Villeneuve
  • Mulhouse, France, 68100
    • GHR Sud Alsace - Hopital Emile Muller
  • Paris, France
    • Institut Curie
  • Pessac, France, 33600
    • CHU de Bordeaux Hôpital Haut Lévêque
  • Pierre-Bénite, France, 69495
    • Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud
  • Poitiers, France, 86021
    • Chu de Poitiers
  • Rouen, France, 76031
    • Centre Hospitalier Universitaire de Rouen - Hopitel Charles Nicolle
  • Saint-Herblain, France, 44805
    • Institut de Cancérologie de l'Ouest - Paysde Loire (site SAINT HERBLAIN)
  • Saint-Herblain, France
    • Hopital Foch
  • Strasbourg, France, 67033
    • Institut Cancérologie Strasbourg Europe
  • Toulon, France, 83056
    • CHITS-Hopital Sainte Musse
• Germany
  • Braunschweig, Germany, 38114
    • Stadtisches Klinikum Braunschweig gGmbH Medizinische Klinik III Hamatologie und Onkologie
  • Esslingen am Neckar, Germany, 73730
    • Klinikum Esslingen GmbH Klinik fur Kardiologie,Angiologie und Pneumologie
  • Hamburg, Germany, 21075
    • Asklepios Klinikum Harburg, Thoraxzentrum Hamburg - Lungenabteilung
  • Hamburg, Germany
    • Studiengeselischaft Hamato-Onkologie Hamburg
  • Heilbronn, Germany, 74245
    • Onkologische Schwerpunktpraxis Heilbronn
  • Immenhausen, Germany, 34376
    • Lungenfachklink Immenhausen
  • Kassel, Germany, 34125
    • Klinikum Kassel Klinik Für Hämatologie Onkologie Und Immunologie
  • Lübeck, Germany, 23538
    • Universitatsklinikum Schleswig-Holstein - Campus Lubeck, Medizinische Klinik III (Studienzentrum Pneumologie)
  • Mannheim, Germany, 68167
    • University Hospital Mannheim, Department of Personalized Medical Oncology with Section Thoracic Oncology
  • Munchen-Gauting, Germany, 82131
    • Asklepios-Fachkliniken Munchen-Gauting, Zentrum fur Pneumologie und Thoraxchirurgie
  • Offenbach, Germany, 63069
    • Sana Klinikum Offenbach, Medizinische Klinik IV fur Hamatologie und internistische Onkologie
• Greece
  • Athens, Greece, 11526
    • Henry Dunant Hospital Center, 4th Oncology Department
  • Athens, Greece, 11527
    • General Hospital of Chest Diseases "I Sotiria", 3rd Internal Medicine Department of Athens University - Oncology Unit
  • Cholargós, Greece, 15562
    • Metropolitan General, Oncology department
  • Heraklion, Greece
    • General Oncology Hospital of Kifisia "Agioi Anargyroi", 2nd Department of Medical Oncology
  • Larissa, Greece, 413 34
    • University General Hospital of Larissa, Oncology Department-1St Internal Medical Division
  • Nea Kifissia, Greece, 14565
    • General Oncology Hospital of Kifisia "Agioi Anargyroi", 2nd Department of Medical Oncology
  • Thessaloniki, Greece, 555 35
    • Interbalkan Medical Center of Thessaloniki
  • Thessaloniki, Greece, 54645
    • Euromedica General Clinic of Thessaloniki
• Israel
  • Ashdod, Israel, 7747629
    • Samson Assuta Ashdod University Hospital
  • Beersheba, Israel, 84101
    • Soroka Medical Center
  • Jerusalem, Israel
    • Hadassah University Hospital Ein Kerem
  • Rehovot, Israel, 76100
    • Kaplan Medical Center
  • Tel Aviv, Israel
    • Tel Aviv Sourasky Medical Center
  • Tzrifin, Israel
    • Shamir Medical Center (Assaf Harofeh)
• Italy
  • Bergamo, Italy, 24127
    • ASST Papa Giovanni XXIII, Oncologia Medica
  • Brescia, Italy, 25123
    • Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia
  • Catania, Italy, 95125
    • AOU Policlinico G Rodlico-Oncologia Medica
  • Catanzaro, Italy, 88100
    • AOU mater Domini, UOC Oncologia Medica e Oncologia Medica Trazionale
  • Cremona, Italy, 26100
    • ASST Cremona
  • Milan, Italy, 20141
    • Instituto Europeo di Oncologia
  • Milan, Italy, 20162
    • ASST Grande Ospedale Metropolitano Niguarda SC Oncologia
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico San Matteo
  • Roma, Italy, 00128
    • Fondazione Policlinico Universitario Campus Bio-Medico, UOC Oncologia Medica
  • San Giovanni Rotondo, Italy, 71013
    • UOC Oncologia
  • Treviglio, Italy, 24047
    • ASST Bergamo Ovest- ospedale di Treviglio-u.o. Oncologia
  • Varese, Italy, 21100
    • SC Oncologia -ASST SETTE LAGHI
• Japan
  • Asahikawa, Japan, 070-8644
    • National Hospital Organization Asahikawa Medical Center
  • Chūō, Japan, 104-0045
    • National Cancer Center Hospital
  • Fukui, Japan, 910-8526
    • Fukui Prefectural Hospital
  • Hirakata, Japan, 573-1191
    • Kansai Medical University Hospital
  • Hiroshima, Japan, 734-8551
    • Hiroshima University Hospital
  • Hyōgo, Japan, 650-0047
    • Kobe City Medical Center General Hospital
  • Hyōgo, Japan, 670-8520
    • National Hospital Organization Himeji Medical Center
  • Inzai, Japan, 270-1694
    • Nippon Medical School Chiba Hokusoh Hospital
  • Iwakuni, Japan, 740-8510
    • National Hospital Organization Iwakuni Clinical Center
  • Kagoshima, Japan, 8908520
    • Kagoshima University Hospital
  • Kanagawaken, Japan, 236-0051
    • Kanagawa Prefectural Hospital Organization Kanagawa Cardiovascular and Respiratory Center
  • Kanazawa, Japan, 920-8641
    • Kanazawa University Hospital
  • Kashiwa, Japan, 277-8577
    • National Cancer Center Hospital East
  • Kitaadachi-gun, Japan, 362-0806
    • Saitama Cancer Center
  • Kurume, Japan, 830-0011
    • Kurume University Hospital
  • Kyoto, Japan, 602-8566
    • University Hospital Kyoto Prefectural University of Medicine
  • Kōtō City, Japan, 135-8550
    • The Cancer Institute Hospital Of JFCR
  • Matsuyama, Japan, 791-0280
    • Shikoku Cancer Center
  • Miyagi, Japan, 981-1293
    • Miyagi Cancer Center
  • Nagasaki, Japan, 852-8501
    • Nagasaki University Hospital
  • Nagoya, Japan, 460-0001
    • National Hospital Organization Nagoya Medical Center
  • Niigata, Japan, 951-8566
    • Niigata Cancer Center Hospital
  • Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Osaka, Japan, 541-8567
    • Osaka Prefectural Hospital Organization Osaka International Cancer Institute
  • Osakasayama-Shi, Japan, 589-8511
    • Kindai University Hospital
  • Sakai, Japan, 591-8555
    • National Hospital Organization Kinki-Chuo Chest Medical Center
  • Shinjuku-Ku, Japan, 162-8655
    • Centor Hospital of the National Center for Global Health and Medicine
  • Sunto-gun, Japan, 411-8777
    • Shizuoka Cancer Center
  • Toyonaka, Japan, 560-8552
    • National Hospital Organization Osaka Toneyama Medical Center
  • Utsunomiya, Japan, 320-0834
    • Tochigi Cancer Center
  • Wakayama, Japan, 640-8558
    • Japanese Red Cross Wakayama Medical Center
  • Yokohama, Japan, 221-0855
    • Yokohama Municipal Citizen's Hospital
  • Yokohama, Japan, 241-8515
    • Kanagawa cancer center
  • Yonago, Japan, 683-8504
    • Tottori University Hospital
• Mexico
  • Guadalajara, Mexico, 44670
    • Panamerican Clinical Research S.A. de C.V
  • Guadalajara, Mexico
    • Actualidad Basada en la Investigación del Cáncer
  • Mexico City, Mexico, 06100
    • Cryptex Investigación Clínica, S.A. de C.V.
• Netherlands
  • Breda, Netherlands, 4818 CK
    • Amphia Hospital
  • Maastricht, Netherlands, 6229 HX
    • Maastricht Universitair Medisch Centrum
  • Rotterrdam, Netherlands, 3015
    • Erasmus MC
  • The Hague, Netherlands, 2262BA
    • Haaglanden Medical Centre
  • Tilburg, Netherlands, 5022
    • Elisabeth-TweeSteden Ziekenhuis (ETZ)
• Poland
  • Konin, Poland, 62-500
    • Przychodnia Lekarska KOMED Roman Karaszewski
  • Lodz, Poland, 90-302
    • Instytut MSF Sp. z o.o.
  • Rzeszáw, Poland, 35-085
    • Centrum Medyczne Mrukmed
  • Siedlce, Poland, 08-110
    • Marzowiecki Szpital Wojewodzki sw Jana Pawla II Wsiedicach sp. z.o.o Siedickie centrum onkoiogii
• Portugal
  • Coimbra, Portugal, 3000-075
    • Instituto Português de Oncologia de Coimbra Francisco Gentil
  • Lisbon, Portugal
    • Fundacao Champalimaud
  • Lisbon, Portugal, 1769-001
    • Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido Valente
  • Matosinhos Municipality, Portugal, 4464-513
    • Senhora da Hora
  • Porto, Portugal, 4099-001
    • Centro Hospitalar Universitario do Porto
  • Porto, Portugal, 4200-072
    • Instituto Portugues de Oncologia do Porto
  • Porto, Portugal, 14341
    • Hospital CUF Porto
• Puerto Rico
  • Ponce, Puerto Rico, 00717
    • Ad-Vance Medical Research, LLC
  • PR
    • San Juan, PR, Puerto Rico, 00902
      • Pan American Center for Oncology Trials, LLC
• Spain
  • A Coruña, Spain, 15006
    • Complejo Hospitalario Universitario A Coruna. Hospital Teresa Herrera
  • Badalona, Spain, 08916
    • Institut Catala d'Oncologia Badalona, ICO Badalona, Hospital Germans Trias i Pujol
  • Barakaldo, Spain, 48903
    • Hospital Universitario Cruces
  • Barcelona, Spain, 08028
    • Hospital Universitari Dexeus
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron
  • Barcelona, Spain, 08908
    • Institut Catala D'Oncologia (ICO L'Hospitalet) Hospital Duran i Reynals
  • Cáceres, Spain, 10004
    • Hospital San Pedro de Alcantara
  • Girona, Spain, 17007
    • Institut Catala d'Oncologia de Girona
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28006
    • Hospital Universitario de La Princesa
  • Madrid, Spain, 28007
    • Hospital Universitario Gregorio Maranon
  • Madrid, Spain, 28041
    • Hospital Universitario 12 Octubre
  • Madrid, Spain, 28040
    • Hospital Clinical San Carlos
  • Madrid, Spain, 28020
    • Hospital Universitario Fundacion Jimenez Dias
  • Murcia, Spain, 30120
    • Hospital Clinicl universitario virgen de la Arrixaca
  • Málaga, Spain, 29010
    • Hospital Regional Universitario de Malaga-Hospital Civil
  • Pamplona, Spain, 31008
    • Clinica Universidad de Navarra-Pamplona
  • Sabadell, Spain, 8208
    • Hospital de Sabadell
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Seville, Spain, 41001
    • Hospital Virgen de Valme
  • Valencia, Spain, 46026
    • Hospital Universitario La Fe
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06230
    • Hacettepe Universitesi Hastanesi
  • Ankara, Turkey (Türkiye), 06520
    • Memorial Ankara Hastane
  • Bursa, Turkey (Türkiye), 16059
    • Acibadem Bursa Hastanesi
  • Dikimevi- Ankara, Turkey (Türkiye), 06100
    • Ankara Sehir Hastanesi
  • Edirne, Turkey (Türkiye)
    • Trakya Üniversitesi Sağlık Araştırma ve Uygulama Merkezi
  • Istanbul, Turkey (Türkiye)
    • Bagcilar Medipol Mega Universite Hastanesi
  • Kadıköy, Turkey (Türkiye)
    • T.C. Saglik Bakanligi Goztepe Prof. Dr Suleyman Yalcin Sehir Hastanesi
  • Yellowplace, Turkey (Türkiye)
    • Acibadem Maslak Hastanesi
  • Yenimahalle, Turkey (Türkiye)
    • Gazi Universitesi Gazi Hastanesi
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • University Hospital Birmingham NHS Trust, Birmingham Heartlands Hospital
  • Colchester, United Kingdom, CO4 5JL
    • East Suffolk and North Essex NHS Foundation Trust
  • Glasgow, United Kingdom, G12 0YN
    • The Beatson West of Scotland Cancer Centre
  • Leeds, United Kingdom, LS9 7TF
    • St James University Hospital
  • Leicester, United Kingdom, LE1 5WW
    • Leicester Royal Infirmary
  • London, United Kingdom, EC1A 7BE
    • Barts Health NHS Trust
  • Manchester, United Kingdom, M20 4BX
    • The Christie NHS Foundation
• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Oncology and Hematology, LLC.
  • Arizona
    • Tucson, Arizona, United States, 85711
      • USOR - Arizona Oncology Associates Tucson - Wilmot
  • California
    • Beverly Hills, California, United States, 90211
      • Beverly Hills Cancer Center
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Rocky Mountain Cancer Centers - Aurora
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Florida Cancer Specialists (Administration and Drug Shipment)
    • Pensacola, Florida, United States, 32503
      • Woodlands Medical Specialists, PA
    • St. Petersburg, Florida, United States, 33705
      • Florida Cancer Specialists
    • West Palm Beach, Florida, United States, 33401
      • Florida Cancer Specialists
  • Illinois
    • Chicago, Illinois, United States, 60607
      • University of Chicago Medical Center
    • Niles, Illinois, United States, 60714
      • Illinois Cancer Specialists
  • Iowa
    • Sioux City, Iowa, United States, 51101
      • Siouxland Regional Cancer Center dba June E. Nylen Cancer Center
  • Kansas
    • Westwood, Kansas, United States, 66205
      • Kansas City VA Medical Center
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
  • Maryland
    • Clinton, Maryland, United States, 20735
      • Maryland Oncology Hematology, P.A.
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Hospital & Medical Center
  • Minnesota
    • Saint Paul, Minnesota, United States, 55101
      • Park Nicollet Frauenshuh Cancer Center
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Nebraska Hematology - Oncology
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Comprehensive Cancer Centers of Nevada
  • New York
    • Johnson City, New York, United States, 13790
      • Broome Oncology, LLC
    • Stony Brook, New York, United States, 11794
      • Stony Brook Cancer Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute
    • Pinehurst, North Carolina, United States, 28374
      • FirstHealth Outpatient Cancer Center
    • Salisbury, North Carolina, United States, 28144
      • W.G (Bill) Hefner VAMC
  • Ohio
    • Columbus, Ohio, United States, 43219
      • Zangmeister Cancer Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Tennessee Oncology, PLLC
    • Memphis, Tennessee, United States, 38120
      • Baptist Clinical Research Institute
  • Texas
    • Bedford, Texas, United States, 76022
      • Texas Oncology - Bedford
    • Denison, Texas, United States, 75020
      • Texas Oncology - Denison
    • Denton, Texas, United States, 76201
      • Texas Oncology - Denton South
    • McAllen, Texas, United States, 78503
      • Texas Oncology Cancer Care and Research Center
    • McKinney, Texas, United States, 75071
      • USOR - Texas Oncology - McKinney
    • Paris, Texas, United States, 75460
      • Texas Oncology - Paris
    • Plano, Texas, United States, 75093
      • Texas Oncology-Plano West
    • Plano, Texas, United States, 75075
      • Texas Oncology-Plano East
  • Virginia
    • Winchester, Virginia, United States, 22601
      • Shenandoah Oncology Associates, PC
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Clinical Science Center
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert Hospital/Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Pathologically documented non-small cell lung cancer (NSCLC) with documented evidence of Stage 4 NSCLC disease at the time of enrollment (based on the American Joint Committee on Cancer, Eighth Edition).
• Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and programmed death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) results are required. Testing prior to enrollment. Resulting for other actionable genomic alterations is recommended and to be performed as per local standard of care and availability of targeted treatment. For patients with squamous cell carcinoma, EGFR and ALK testing is optional.

• Must have progressed after platinum-based chemotherapy in combination with anti-PD-1/PD-L1 antibody OR platinum-based chemotherapy and anti-PD-1/PD-L1 antibody (in either order) sequentially.

  • No additional treatments are allowed in the recurrent/metastatic setting for individuals with no actionable genomic alterations.
  • Individuals with EGFR, ALK, or any other known actionable genomic alterations must have also received treatment with at least 1 locally approved and available tyrosine kinase inhibitor 1(TKI) appropriate to the genomic alteration.
  • Documented radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.
• Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by the investigator in accordance with per RECIST Version 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 before randomization.
• Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g/dL, absolute neutrophil count ≥ 1500/mm^3, and platelets ≥ 100,000/μL).
• Adequate hepatic function (bilirubin ≤ 1.5 x upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase ≤ 2.5 ULN or ≤ 5 x ULN if known liver metastases, and serum albumin > 3 g/dL).
• Creatinine clearance of at least 30 mL/min as assessed by the Cockcroft-Gault equation.
• Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.

Key Exclusion Criteria:

• Mixed small-cell lung cancer and NSCLC histology.
• Positive serum pregnancy test or women who are lactating.
• Received a prior anticancer biologic agent within 4 weeks prior to enrollment or have received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to enrollment and have not recovered (ie, > Grade 2 is considered not recovered) from adverse events (AEs) at the time of study entry. Individuals participating in observational studies are eligible.
• Have not recovered (ie, > Grade 2 is considered not recovered) from AEs due to a previously administered agent.

• Previously received treatment with any of the following:

  • Topoisomerase 1 inhibitors. Any agent including an antibody-drug conjugate (ADC) containing a chemotherapeutic agent targeting topoisomerase 1
  • Trop-2-targeted therapy
  • Docetaxel as monotherapy or in combination with other agents
• Active second malignancy
• NSCLC that is eligible for definitive local therapy alone.
• Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc); any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren syndrome, sarcoidosis, etc); or prior pneumonectomy.
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Active cardiac disease
• Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months of enrollment.
• Active serious infection requiring antibiotics.
• Positive HIV-1 or HIV-2 antibody with detectable viral load OR taking medications that may interfere with SN-38 metabolism.
• Positive for hepatitis B surface antigen. Individuals who test positive for hepatitis B core antibody will require hepatitis B virus DNA by quantitative polymerase chain reaction for confirmation of active disease.
• Positive hepatitis C antibody and detectable hepatitis C viral load.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sacituzumab Govitecan-hziy (SG); Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle (ie, 2 weekly doses plus 1 week without treatment) until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met.	Biological: Sacituzumab Govitecan-hziy (SG); Administered intravenously; Other Names: IMMU-132; GS-0132
Active Comparator: Docetaxel; Participants will receive docetaxel 75 mg/m^2 on Day 1 of a 21-day cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion is met.	Drug: Docetaxel; Administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from the date of randomization until the date of death from any cause. OS was estimated using Kaplan-Meier estimate. Participants without documentation of death were censored on the date they were last known to be alive.	Up to 24.4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS) Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1	PFS is defined as the time from the date of randomization until the date of objective disease progression (PD) or death from any cause, whichever occurs first as assessed by RECIST v.1.1. As per RECIST 1.1, PD was defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study), in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or the appearance of of 1 or more new lesions or unequivocal progression of existing non-target lesions. Participants who did not have documented disease progression and did not die were censored at their last tumor assessment date. Kaplan-Meier estimate was used for analysis.	Up to 24.4 months
Objective Response Rate (ORR) Assessed by Investigator Per RECIST Version 1.1	ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) that was confirmed at least 4 weeks later as assessed by RECIST v.1.1. As per RECIST 1.1 CR was defined as: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR was defined as: At least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.	Up to 24.4 months
Duration of Response (DOR) Assessed by Investigator Per RECIST Version 1.1	DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of PD or death from any cause (whichever comes first) as assessed by RECIST v. 1.1. As per RECIST 1.1 CR was disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR was at least 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD, and PD was at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study), in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or the appearance of of 1 or more new lesions or unequivocal progression of existing non-target lesions. Kaplan-Meier estimate was used for analysis.	Up to 24.4 months
Disease Control Rate (DCR) Assessed by Investigator Per RECIST Version 1.1	DCR was defined as the percentage of participants who achieved a CR, PR,or stable disease(SD)as assessed by RECIST v.1.1. Per RECIST 1.1 CR was disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal;PR was at least 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference the smallest sum LD since the treatment started and persistence of 1 or more nontarget lesion(s).PD was at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study),in addition of increase of 20% sum also demonstrate an absolute increase of at least 5 mm or appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions.	Up to 24.4 months
Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs)	An AE was defined as any untoward medical occurrence in a participants administered a medicinal product that does not necessarily have a causal relationship with this treatment. TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of the study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0.	Up to 3.5 years
Percentage of Participants Who Experienced Grade 3 or 4 Treatment Emergent Laboratory Abnormalities Post-Baseline	Blood samples were collected for hematology, serum chemistry, and the laboratory abnormalities were assessed. A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last study drug dose plus 30 days.The most severe graded abnormality observed post-baseline for each graded test was counted for each participant. Safety as assessed by grading of laboratory values and AEs according to the National Cancer Institutes' Common Terminology Criteria for Adverse Events (NCI CTCAE) covering grades 0-5 (0=Normal, 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death). The percentage of participants with worst postbaseline grades 3 or 4 will be reported.	Up to 3.5 years
Time to First Deterioration in Shortness of Breath Domain as Measured by Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)	The NSCLC-SAQ is a participant reported outcome with seven items assessing five symptom concepts of NSCLC: cough, pain, dyspnea, fatigue, and appetite. Each item is rated using a five-point verbal rating scale from "No <symptom> At All" to "Very severe <symptom>" or from "Never to Always" depending on the item's question structure relative to either intensity or frequency, corresponding to a score of 0 to 4, with total score ranging from 0 to 20. The dyspnea (shortness of breath) item uses a "Never(0) to Always(4)" rating scale with higher score indicating higher frequency of dyspnea. Time to deterioration (TTD) was defined as the time from date of randomization to the first date a participant achieves 2-point deterioration from baseline. For shortness of breath domain, a 1-point or greater worsening from baseline represents a clinically meaningful deterioration. Kaplan-Meier estimate was used for analysis.	Up to 24.4 months
Time to First Deterioration in NSCLC-SAQ Total Score	The NSCLC-SAQ is a participant reported outcome measure with seven items assessing five symptom concepts of NSCLC: cough, pain, dyspnea, fatigue, and appetite. Each item is rated using a five-point verbal rating scale from "No <symptom> At All" to "Very severe <symptom>" or from "Never to Always" depending on the item's question structure relative to either intensity or frequency, corresponding to a score of 0 to 4. A total score sums all five domain scores at each visit. If any domain score was missing, the score was not computed. The total score ranges between 0 and 20, with higher scores indicating more severe symptoms. TTD was defined as the time from date of randomization to the first date a participant achieves 2-point deterioration from baseline. For NSCLC-SAQ total score, a 2-point or greater worsening from baseline represents a clinically meaningful deterioration. Kaplan-Meier estimate was used for analysis.	Up to 24.4 months

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

General Publications

• Paz-Ares LG, Juan-Vidal O, Mountzios GS, Felip E, Reinmuth N, de Marinis F, Girard N, Patel VM, Takahama T, Owen SP, Reznick DM, Badin FB, Cicin I, Mekan S, Patel R, Zhang E, Karumanchi D, Garassino MC. Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study. J Clin Oncol. 2024 Aug 20;42(24):2860-2872. doi: 10.1200/JCO.24.00733. Epub 2024 May 31.

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2021
• Primary Completion (Actual): November 29, 2023
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: October 11, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Taxoids; Cyclodecanes; Diterpenes; Docetaxel; sacituzumab govitecan
• Other Study ID Numbers: GS-US-577-6153; jRCT2051220119 (Registry Identifier: Japan Registry of Clinical Trials); 2024-512148-50 (Other Identifier: European Medicines Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No