AzTrials
AzTrials

Non-Small Cell Lung CancerPhase 3EVOKE-01NCT05089734

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

A Phase 3 study testing Sacituzumab Govitecan-hziy (SG) and Docetaxel in people with Non-Small Cell Lung Cancer, run by Gilead Sciences at 227 sites in 20 countries.

Active, not recruiting

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

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Sacituzumab Govitecan-hziy (SG) and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
603 participants
Where
227 sitesin 20 countries
Study dates
17 Nov 2021to Jan 2027
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

227 sites in 20 countries.

227 sites in 20 countries

United States37 sites

  • Alaska Oncology and Hematology, LLC.

    Anchorage, Alaska, 99508

  • Rocky Mountain Cancer Centers - Aurora

    Aurora, Colorado, 80012

  • Texas Oncology - Bedford

    Bedford, Texas, 76022

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 01805

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Tennessee Oncology, PLLC

    Chattanooga, Tennessee, 37404

  • University of Chicago Medical Center

    Chicago, Illinois, 60607

  • Maryland Oncology Hematology, P.A.

    Clinton, Maryland, 20735

  • Zangmeister Cancer Center

    Columbus, Ohio, 43219

  • Texas Oncology - Denison

    Denison, Texas, 75020

  • Texas Oncology - Denton South

    Denton, Texas, 76201

  • Florida Cancer Specialists (Administration and Drug Shipment)

    Fort Myers, Florida, 33901

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89052

  • Broome Oncology, LLC

    Johnson City, New York, 13790

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Nebraska Hematology - Oncology

    Lincoln, Nebraska, 68506

  • University of Wisconsin Clinical Science Center

    Madison, Wisconsin, 53792

  • Texas Oncology Cancer Care and Research Center

    McAllen, Texas, 78503

  • USOR - Texas Oncology - McKinney

    McKinney, Texas, 75071

  • Baptist Clinical Research Institute

    Memphis, Tennessee, 38120

  • Froedtert Hospital/Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Illinois Cancer Specialists

    Niles, Illinois, 60714

  • Texas Oncology - Paris

    Paris, Texas, 75460

  • Woodlands Medical Specialists, PA

    Pensacola, Florida, 32503

  • FirstHealth Outpatient Cancer Center

    Pinehurst, North Carolina, 28374

  • Texas Oncology-Plano East

    Plano, Texas, 75075

  • Texas Oncology-Plano West

    Plano, Texas, 75093

  • Park Nicollet Frauenshuh Cancer Center

    Saint Paul, Minnesota, 55101

  • W.G (Bill) Hefner VAMC

    Salisbury, North Carolina, 28144

  • Siouxland Regional Cancer Center dba June E. Nylen Cancer Center

    Sioux City, Iowa, 51101

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

  • Stony Brook Cancer Center

    Stony Brook, New York, 11794

  • USOR - Arizona Oncology Associates Tucson - Wilmot

    Tucson, Arizona, 85711

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401

  • Kansas City VA Medical Center

    Westwood, Kansas, 66205

  • Shenandoah Oncology Associates, PC

    Winchester, Virginia, 22601

Other trials in United States

Japan34 sites

  • National Hospital Organization Asahikawa Medical Center

    Asahikawa, 070-8644

  • National Cancer Center Hospital

    Chūō, 104-0045

  • Fukui Prefectural Hospital

    Fukui, 910-8526

  • Kansai Medical University Hospital

    Hirakata, 573-1191

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Kobe City Medical Center General Hospital

    Hyōgo, 650-0047

  • National Hospital Organization Himeji Medical Center

    Hyōgo, 670-8520

  • Nippon Medical School Chiba Hokusoh Hospital

    Inzai, 270-1694

  • National Hospital Organization Iwakuni Clinical Center

    Iwakuni, 740-8510

  • Kagoshima University Hospital

    Kagoshima, 8908520

  • Kanagawa Prefectural Hospital Organization Kanagawa Cardiovascular and Respiratory Center

    Kanagawaken, 236-0051

  • Kanazawa University Hospital

    Kanazawa, 920-8641

  • National Cancer Center Hospital East

    Kashiwa, 277-8577

  • Saitama Cancer Center

    Kitaadachi-gun, 362-0806

  • The Cancer Institute Hospital of JFCR

    Kōtō City, 135-8550

  • Kurume University Hospital

    Kurume, 830-0011

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Shikoku Cancer Center

    Matsuyama, 791-0280

  • Miyagi Cancer Center

    Miyagi, 981-1293

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • National Hospital Organization Nagoya Medical Center

    Nagoya, 460-0001

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Okayama University Hospital

    Okayama, 700-8558

  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute

    Osaka, 541-8567

  • Kindai University Hospital

    Osakasayama-Shi, 589-8511

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Sakai, 591-8555

  • Centor Hospital of the National Center for Global Health and Medicine

    Shinjuku-Ku, 162-8655

  • Shizuoka Cancer Center

    Sunto-gun, 411-8777

  • National Hospital Organization Osaka Toneyama Medical Center

    Toyonaka, 560-8552

  • Tochigi Cancer Center

    Utsunomiya, 320-0834

  • Japanese Red Cross Wakayama Medical Center

    Wakayama, 640-8558

  • Yokohama Municipal Citizen's Hospital

    Yokohama, 221-0855

  • Kanagawa Cancer Center

    Yokohama, 241-8515

  • Tottori University Hospital

    Yonago, 683-8504

Other trials in Japan

France24 sites

  • Institut Sainte Catherine

    Avignon, 84918

  • Centre Hospitalier de la Côte Basque

    Bayonne, 64100

  • APHP-Hopital Ambroise-Pare

    Boulogne-Billancourt, 92100

  • CHU de CAEN

    Caen, 14033

  • Centre Francois Baclesse

    Calvados, 14076 CEDEX 05

  • Centre Hospitalier de Chauny

    Chauny, 02300

  • CHU-Hopital Gabriel Montpied

    Clermont-Ferrand, 63000

  • Centre Hospitalier Intercommunal de Creteil

    Créteil, 94010

  • Centre Hospitalier Annecy Genevois

    Epagny Metz-tessy, 74374

  • Centre Hospitalier Departemental Vendee

    La Roche-sur-Yon, 85925

  • Clinique Victor Hugo

    Le Mans, 72000

  • CHU de Lille

    Lille, 59000

  • Hopital Dupuytren (CHU de Limoges)

    Limoges, 87042

  • Chu Montpellier Hopital Arnaud de Villeneuve

    Montpellier, 34295 CEDEX

  • GHR Sud Alsace - Hopital Emile Muller

    Mulhouse, 68100

  • Institut Curie

    Paris

  • CHU de Bordeaux Hopital Haut leveque

    Pessac, 33600

  • Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud

    Pierre-Bénite, 69495

  • CHU de Poitiers

    Poitiers, 86021

  • Centre Hospitalier Universitaire de Rouen - Hopitel Charles Nicolle

    Rouen, 76031

  • Institut de Cancérologie de l'Ouest - Paysde Loire (site SAINT HERBLAIN)

    Saint-Herblain, 44805

  • Hopital Foch

    Saint-Herblain

  • Institut Cancérologie Strasbourg Europe

    Strasbourg, 67033

  • CHITS-Hopital Sainte Musse

    Toulon, 83056

Other trials in France

Spain22 sites

  • Complejo Hospitalario Universitario A Coruna. Hospital Teresa Herrera

    A Coruña, 15006

  • Institut Catala d'Oncologia Badalona, ICO Badalona, Hospital Germans Trias i Pujol

    Badalona, 08916

  • Hospital Universitario Cruces

    Barakaldo, 48903

  • Hospital Universitari Dexeus

    Barcelona, 08028

  • Hospital Universitario Vall D'Hebron

    Barcelona, 08035

  • Institut Catala D'Oncologia (ICO L'Hospitalet) Hospital Duran i Reynals

    Barcelona, 08908

  • Hospital San Pedro de Alcantara

    Cáceres, 10004

  • Institut Catala d'Oncologia de Girona

    Girona, 17007

  • Hospital Universitario de la Princesa

    Madrid, 28006

  • Hospital Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario Fundacion Jimenez Dias

    Madrid, 28020

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Clinical San Carlos

    Madrid, 28040

  • Hospital Universitario 12 Octubre

    Madrid, 28041

  • Hospital universitario la paz

    Madrid, 28046

  • Hospital Regional Universitario de Malaga-Hospital Civil

    Málaga, 29010

  • Hospital Clinicl universitario virgen de la Arrixaca

    Murcia, 30120

  • Clinica Universidad de Navarra-Pamplona

    Pamplona, 31008

  • Hospital de Sabadell

    Sabadell, 8208

  • Hospital Virgen de Valme

    Seville, 41001

  • Hospital universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario la Fe

    Valencia, 46026

Other trials in Spain

Australia12 sites

  • Border Medical Oncology Research Unit

    Albury, New South Wales, 2640

  • Flinders Medical centre

    Bedford Park, South Australia, 5042

  • Sunshine Coast University Private Hospital

    Birtinya, Queensland, 4575

  • Southern Highlands Cancer Centre

    Bowral, New South Wales, 2576

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Monash Health

    Clayton, Victoria, 3168

  • St Vincent's Public Hospital

    Darlinghurst, New South Wales, 2010

  • Peninsula & South Eastern Haematology and Oncology Group

    Frankston, Victoria, 3199

  • Gallipoli Medical Research Foundation

    Greenslopes, Queensland, 4120

  • Icon Cancer Centre

    Hobart, Tasmania, 7000

  • Joondalup Health Campus

    Joondalup, Western Australia, 6027

  • ir Charles Gairdner Hospital

    Perth, Western Australia, 6009

Other trials in Australia

Italy12 sites

  • ASST Papa Giovanni XXIII, Oncologia Medica

    Bergamo, 24127

  • Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia

    Brescia, 25123

  • AOU Policlinico G Rodlico-Oncologia Medica

    Catania, 95125

  • AOU mater Domini, UOC Oncologia Medica e Oncologia Medica Trazionale

    Catanzaro, 88100

  • ASST Cremona

    Cremona, 26100

  • Instituto Europeo di Oncologia

    Milan, 20141

  • ASST Grande Ospedale Metropolitano Niguarda SC Oncologia

    Milan, 20162

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Fondazione Policlinico Universitario Campus Bio-Medico, UOC Oncologia Medica

    Roma, 00128

  • UOC Oncologia

    San Giovanni Rotondo, 71013

  • ASST Bergamo Ovest- ospedale di Treviglio-u.o. Oncologia

    Treviglio, 24047

  • SC Oncologia -ASST SETTE LAGHI

    Varese, 21100

Other trials in Italy

Germany11 sites

  • Stadtisches Klinikum Braunschweig gGmbH Medizinische Klinik III Hamatologie und Onkologie

    Braunschweig, 38114

  • Klinikum Esslingen GmbH Klinik fur Kardiologie,Angiologie und Pneumologie

    Esslingen am Neckar, 73730

  • Asklepios Klinikum Harburg, Thoraxzentrum Hamburg - Lungenabteilung

    Hamburg, 21075

  • Studiengeselischaft Hamato-Onkologie Hamburg

    Hamburg

  • Onkologische Schwerpunktpraxis Heilbronn

    Heilbronn, 74245

  • Lungenfachklink Immenhausen

    Immenhausen, 34376

  • Klinikum Kassel Klinik Für Hämatologie Onkologie Und Immunologie

    Kassel, 34125

  • Universitatsklinikum Schleswig-Holstein - Campus Lubeck, Medizinische Klinik III (Studienzentrum Pneumologie)

    Lübeck, 23538

  • University Hospital Mannheim, Department of Personalized Medical Oncology with Section Thoracic Oncology

    Mannheim, 68167

  • Asklepios-Fachkliniken Munchen-Gauting, Zentrum fur Pneumologie und Thoraxchirurgie

    Munchen-Gauting, 82131

  • Sana Klinikum Offenbach, Medizinische Klinik IV fur Hamatologie und internistische Onkologie

    Offenbach, 63069

Other trials in Germany

Brazil9 sites

  • CRIO - Centro Regional Integrado de Oncologia

    Fortaleza, 60810180

  • ONCOSITE - Centro de Pesquisa Clinica em Oncologia

    Ijuí, 98700-000

  • Catatina Pesquisa Clinica - Clinica de Neoplasias Litoral

    Itajaí, 88331-10

  • Centro de Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho

    Jaú, 17210080

  • Hospital de Clínicas de Porto Alegre - HCPA

    Porto Alegre, 90035903

  • Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa

    Porto Alegre, 90110-270

  • Nucleo de Pesquisa da Rede Sao Camilo-Instituto Brasileiro de controle do cancer-IBC

    São Paulo, 03102002

  • A Beneficência Portuguesa de São Paulo

    São Paulo

  • Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP

    São Paulo

Other trials in Brazil

Turkey (Türkiye)9 sites

  • Hacettepe Üniversitesi Hastanesi

    Ankara, 06230

  • Memorial Ankara Hastane

    Ankara, 06520

  • Acibadem Bursa Hastanesi

    Bursa, 16059

  • Ankara Sehir Hastanesi

    Dikimevi- Ankara, 06100

  • Trakya Üniversitesi Sağlık Araştırma ve Uygulama Merkezi

    Edirne

  • Bagcilar Medipol Mega Universite Hastanesi

    Istanbul

  • T.C. Saglik Bakanligi Goztepe Prof. Dr Suleyman Yalcin Sehir Hastanesi

    Kadıköy

  • Acibadem Maslak Hastanesi

    Sariyer

  • Gazi Universitesi Gazi Hastanesi

    Yenimahalle

Other trials in Turkey (Türkiye)

Greece8 sites

  • Henry Dunant Hospital Center, 4th Oncology Department

    Athens, 11526

  • General Hospital of Chest Diseases "I Sotiria", 3rd Internal Medicine Department of Athens University - Oncology Unit

    Athens, 11527

  • Metropolitan General, Oncology department

    Cholargós, 15562

  • General Oncology Hospital of Kifisia "Agioi Anargyroi", 2nd Department of Medical Oncology

    Heraklion

  • University General Hospital of Larissa, Oncology Department-1St Internal Medical Division

    Larissa, 413 34

  • General Oncology Hospital of Kifisia "Agioi Anargyroi", 2nd Department of Medical Oncology

    Nea Kifissia, 14565

  • Euromedica General Clinic of Thessaloniki

    Thessaloniki, 54645

  • Interbalkan Medical Center of Thessaloniki

    Thessaloniki, 555 35

Other trials in Greece

Portugal7 sites

  • Instituto Português de Oncologia de Coimbra Francisco Gentil

    Coimbra, 3000-075

  • Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido Valente

    Lisbon, 1769-001

  • Fundacao Champalimaud

    Lisbon

  • Senhora da Hora

    Matosinhos Municipality, 4464-513

  • Hospital CUF Porto

    Porto, 14341

  • Centro Hospitalar Universitario do Porto

    Porto, 4099-001

  • Instituto Portugues de Oncologia do Porto

    Porto, 4200-072

Other trials in Portugal

United Kingdom7 sites

  • University Hospital Birmingham NHS Trust, Birmingham Heartlands Hospital

    Birmingham, B9 5SS

  • East Suffolk and North Essex NHS Foundation Trust

    Colchester, CO4 5JL

  • The Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • St James University Hospital

    Leeds, LS9 7TF

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

  • Barts Health NHS Trust

    London, EC1A 7BE

  • The Christie NHS Foundation

    Manchester, M20 4BX

Other trials in United Kingdom

Belgium6 sites

  • Algemeen Ziekenhuis Klina

    Brasschaat, 2930

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • Algemeen Ziekenhuis Sint-Lucas

    Ghent, 9000

  • Az Maria Middelares Ghent

    Ghent, 9000

  • CHU Ambroise Pare

    Mons, 7000

Other trials in Belgium

Israel6 sites

  • Samson Assuta Ashdod University Hospital

    Ashdod, 7747629

  • Soroka Medical Center

    Beersheba, 84101

  • Hadassah University Hospital Ein Kerem

    Jerusalem

  • Kaplan Medical Center

    Rehovot, 76100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv

  • Shamir Medical Center (Assaf Harofeh)

    Tzrifin

Other trials in Israel

Canada5 sites

  • Royal Victoria Regional Health Centre

    Barrie, L4M 6M2

  • William Osler Health System-Brampton Civic Hospital

    Brampton, L6R 3J7

  • McGill University Health Centre

    Montreal, H4A 3J1

  • Required Centre Hospitalier Regional de Rimouski

    Rimouski, G5L5T1

  • Windsor Regional Hospital Cancer Program

    Windsor, N8W 2X3

Other trials in Canada

Netherlands5 sites

  • Amphia Hospital

    Breda, 4818 CK

  • Maastricht Universitair Medisch Centrum

    Maastricht, 6229 HX

  • Erasmus MC

    Rotterrdam, 3015

  • Haaglanden Medical Centre

    The Hague, 2262BA

  • Elisabeth-TweeSteden Ziekenhuis (ETZ)

    Tilburg, 5022

Other trials in Netherlands

Austria4 sites

  • Medizinische Universität Innsbruck, Medizinische Universitat Innsbruck, Universitatsklinik fur Innere Medizin V, Hamatologie und Onkolgie

    Innsbruck, 06020

  • Muellner Hauptstrabe 48

    Salzburg, 5020

  • zuniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU

    Salzburg, A-5020

  • Klinik Floridsdorf, Karl Landsteiner Institute fur Lungenforschung und Pneumologische onkologie (LFPO) Abteilung Fur Innere Medizin un Pneumologie

    Vienna, 1210

Other trials in Austria

Poland4 sites

  • Przychodnia Lekarska Komed Roman Karaszewski

    Konin, 62-500

  • Instytut MSF Sp. z o.o.

    Lodz, 90-302

  • Centrum Medyczne Mrukmed

    Rzeszáw, 35-085

  • Marzowiecki Szpital Wojewodzki sw Jana Pawla II Wsiedicach sp. z.o.o Siedickie centrum onkoiogii

    Siedlce, 08-110

Other trials in Poland

Mexico3 sites

  • Panamerican Clinical Research S.A. de C.V

    Guadalajara, 44670

  • Actualidad Basada en la Investigación del Cáncer

    Guadalajara

  • Cryptex Investigación Clínica, S.A. de C.V.

    Mexico City, 06100

Other trials in Mexico

Puerto Rico2 sites

  • Ad-Vance Medical Research, LLC

    Ponce, 00717

  • Pan American Center For Oncology Trials, LLC

    San Juan, PR, 00902

Other trials in Puerto Rico

About this study

Official title: 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).

Being tested
Sacituzumab Govitecan-hziy (SG), Docetaxel
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab Govitecan-hziy (SG)Biological

    Also called IMMU-132, GS-0132

    Administered intravenously

  • DocetaxelDrug

    Administered intravenously

Study groups in NCT05089734
Study groupRoleWhat they receive
Sacituzumab Govitecan-hziy (SG)ExperimentalParticipants 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.
Receives: Biological: Sacituzumab Govitecan-hziy (SG)
DocetaxelActive comparatorParticipants 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.
Receives: Drug: Docetaxel

What is being measured

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

  1. 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.

    Measured: Up to 24.4 months

Secondary outcomes (8)

  1. 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.

    Measured: Up to 24.4 months

  2. 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.

    Measured: Up to 24.4 months

  3. 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.

    Measured: Up to 24.4 months

  4. 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.

    Measured: Up to 24.4 months

  5. 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.

    Measured: Up to 3.5 years

  6. 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.

    Measured: Up to 3.5 years

  7. 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.

    Measured: Up to 24.4 months

  8. 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.

    Measured: Up to 24.4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2021
  2. Study start17 Nov 2021
  3. Primary completion29 Nov 2023
  4. Study completionJan 2027 (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
603 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05089734
Sponsor's protocol ID
GS-US-577-6153
Other IDs
jRCT2051220119, 2024-512148-50
Acronym
EVOKE-01
Status last verified
Apr 2026
First submitted
11 Oct 2021
Last updated
7 May 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 38843511

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sacituzumab Govitecan-hziy (SG) and Docetaxel in people with Non-Small Cell Lung Cancer, run by Gilead Sciences at 227 sites in 20 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 12 inclusion and 19 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 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 227 sites in United States, Japan, France, Spain, Australia and 15 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?

Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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) (time frame: Up to 24.4 months). 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 NCT05089734, which also lists 1 linked publication.

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 7 May 2026.

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