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
  • Gent, Belgium, 9000
    • Az Maria Middelares Ghent
  • Gent, Belgium, 9000
    • Algemeen Ziekenhuis Sint-Lucas
  • Mons, Belgium, 7000
    • CHU Ambroise Pare
• Brazil
  • Fortaleza, Brazil, 60810180
    • Crio - Centro Regional Integrado de Oncologia
  • Ijui, Brazil, 98700-000
    • ONCOSITE - Centro de Pesquisa Clinica em Oncologia
  • Itajai, Brazil, 88331-10
    • Catatina Pesquisa Clinica - Clinica de Neoplasias Litoral
  • Jau, Brazil, 17210080
    • Centro de Pesquisas Clinicas 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
  • Sao Paolo, Brazil
    • Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP
  • Sao Paulo, Brazil, 03102002
    • Nucleo de Pesquisa da Rede Sao Camilo-Instituto Brasileiro de controle do cancer-IBC
  • São Paulo, Brazil
    • A Beneficência Portuguesa de São Paulo
• 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
  • Creteil, France, 94010
    • Centre Hospitalier Intercommunal de Créteil
  • Epagny Metz-tessy, France, 74374
    • Centre Hospitalier Annecy Genevois
  • La Roche-sur-Yon, France, 85925
    • Centre Hospitalier Départemental VENDEE
  • Le Mans, France, 72000
    • Clinique Victor Hugo
  • Lille, France, 59000
    • CHU de Lille
  • Limoges cedex, 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 cedex 05, France
    • Institut Curie
  • Pessac, France, 33600
    • CHU de Bordeaux Hopital Haut leveque
  • Pierre Benite, 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
    • Hopital Foch
  • Strasbourg, France, 67033
    • Institut Cancérologie Strasbourg Europe
  • Toulon cedex, France, 83056
    • CHITS-Hopital Sainte Musse
  • saint Herblain, France, 44805
    • Institut de Cancérologie de l'Ouest - Paysde Loire (site SAINT HERBLAIN)
• Germany
  • Braunschweig, Germany, 38114
    • Stadtisches Klinikum Braunschweig gGmbH Medizinische Klinik III Hamatologie und Onkologie
  • Esslingen, 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
  • Lubeck, 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
  • Cholargos, Greece, 15562
    • Metropolitan General, Oncology department
  • Heraklion, Greece
    • General Oncology Hospital of Kifisia "Agioi Anargyroi", 2nd Department of Medical Oncology
  • Larisa, Greece, 413 34
    • University General Hospital of Larissa, Oncology Department-1St Internal Medical Division
  • Nea Kifisia, 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
  • Beer Seva, 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
  • Milano, Italy, 20141
    • Instituto Europeo di Oncologia
  • Milano, 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
  • Chuo, 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
  • Hyogo, Japan, 650-0047
    • Kobe City Medical Center General Hospital
  • Hyogo, 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
  • Koto, Japan, 135-8550
    • The Cancer Institute Hospital of JFCR
  • Kurume, Japan, 830-0011
    • Kurume University Hospital
  • Kyoto, Japan, 602-8566
    • University Hospital Kyoto Prefectural University of Medicine
  • 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
  • Ciudad de Mexico, Mexico, 06100
    • Cryptex Investigación Clínica, S.A. de C.V.
  • Guadalajara, Mexico, 44670
    • Panamerican Clinical Research S.A. de C.V
  • Guadalajara, Mexico
    • Actualidad Basada en la Investigación del Cáncer
• Netherlands
  • Breda, Netherlands, 4818 CK
    • Amphia Hospital
  • Den Haag, Netherlands, 2262BA
    • Haaglanden Medical Centre
  • Maastricht, Netherlands, 6229 HX
    • Maastricht Universitair Medisch Centrum
  • Rotterrdam, Netherlands, 3015
    • Erasmus MC
  • 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
  • Lisboa, Portugal, 1769-001
    • Centro Hospitalar Universitario Lisboa Norte - Hospital Pulido Valente
  • Lisbon, Portugal
    • Fundação Champalimaud
  • Matosinhos, 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
  • San Juan, Puerto Rico, 00902
    • Pan American Center for Oncology Trials, LLC
• Spain
  • A coruna, 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'Hebrón
  • Barcelona, Spain, 08908
    • Institut Catala D'Oncologia (ICO L'Hospitalet) Hospital Duran i Reynals
  • Cáceres, Spain, 10004
    • Hospital San Pedro de Alcántara
  • Girona, Spain, 17007
    • Institut Catala d'Oncologia de Girona
  • Madrid, Spain, 28034
    • Hospital Universitario Ramón y Cajal
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28006
    • Hospital Universitario de La Princesa
  • Madrid, Spain, 28007
    • Hospital Universitario Gregorio Marañon
  • Madrid, Spain, 28041
    • Hospital Universitario 12 Octubre
  • Madrid, Spain, 28040
    • Hospital Clinical San Carlos
  • Madrid, Spain, 28020
    • Hospital Universitario Fundacion Jimenez Dias
  • Malaga, Spain, 29010
    • Hospital Regional Universitario de Malaga-Hospital Civil
  • Murcia, Spain, 30120
    • Hospital Clinicl universitario virgen de la Arrixaca
  • Pamplona, Spain, 31008
    • Clinica Universidad de Navarra-Pamplona
  • Sabadell, Spain, 8208
    • Hospital de Sabadell
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Sevilla, Spain, 41001
    • Hospital Virgen de Valme
  • Valencia, Spain, 46026
    • Hospital Universitario La Fe
• Turkey
  • Ankara, Turkey, 06230
    • Hacettepe Universitesi Hastanesi
  • Ankara, Turkey, 06520
    • Memorial Ankara Hastane
  • Bursa, Turkey, 16059
    • Acibadem Bursa Hastanesi
  • Dikimevi- Ankara, Turkey, 06100
    • Ankara Sehir Hastanesi
  • Edirne, Turkey
    • Trakya Üniversitesi Sağlık Araştırma ve Uygulama Merkezi
  • Istanbul, Turkey
    • Bagcilar Medipol Mega Universite Hastanesi
  • Kadikoy, Turkey
    • T.C. Saglik Bakanligi Goztepe Prof. Dr Suleyman Yalcin Sehir Hastanesi
  • Sariyer, Turkey
    • Acibadem Maslak Hastanesi
  • Yenimahalle, Turkey
    • 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
    • Saint 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.	Up to 30 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.	Up to 30 months
Objective Response Rate (ORR) Assessed by Investigator per RECIST Version 1.1	ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later.	Up to 30 months
Duration of Response (DOR) Assessed by Investigator per RECIST Version 1.1	DOR is defined as time from first documented CR or PR to the earlier of the first documented PD or death from any cause (whichever comes first)	Up to 30 months
Disease Control Rate (DCR) Assessed by Investigator per RECIST Version 1.1	DCR is defined as the proportion of participants who achieve a CR, PR, or stable disease (SD) as assessed by RECIST Version 1.1.	Up to 30 months
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)		First dose date up to 30 months plus 30 days
Percentage of Participants Experiencing Laboratory abnormalities		First dose date up to 30 months plus 30 days
Time to First Deterioration in Shortness of Breath Domain as Measured by Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) Score	The NSCLC-SAQ is a patient 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," corresponding to a score of 0 to 4. The dyspnea (shortness of breath) item uses a "Never to Always" rating scale with higher score indicating higher frequency of dyspnea.	Up to 30 Months
Time to First Deterioration in NSCLC-SAQ Total Score	The NSCLC-SAQ is a patient 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," corresponding to a score of 0 to 4. The sum of all 5 domain scores will be computed, if any scores are missing, a total score will not be computed. The total score ranges between 0 and 20 with higher scores indicating more severe symptoms.	Up to 30 Months

Collaborators and Investigators

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

Publications and helpful links

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): March 1, 2025

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): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Immunoconjugates; Docetaxel; Sacituzumab govitecan
• Other Study ID Numbers: GS-US-577-6153; 2021-003578-30 (Registry Identifier: European Medicines Agency); jRCT2051220119 (Registry Identifier: Japan Registry of Clinical Trials)

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