Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
NCT ID: NCT05089734
Last Updated: 2025-05-23
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
603 participants
INTERVENTIONAL
2021-11-17
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Sacituzumab Govitecan-hziy (SG)
Administered intravenously
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.
Docetaxel
Administered intravenously
Interventions
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Sacituzumab Govitecan-hziy (SG)
Administered intravenously
Docetaxel
Administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Alaska Oncology and Hematology, LLC.
Anchorage, Alaska, United States
USOR - Arizona Oncology Associates Tucson - Wilmot
Tucson, Arizona, United States
Beverly Hills Cancer Center
Beverly Hills, California, United States
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado, United States
Florida Cancer Specialists (Administration and Drug Shipment)
Fort Myers, Florida, United States
Woodlands Medical Specialists, PA
Pensacola, Florida, United States
Florida Cancer Specialists
St. Petersburg, Florida, United States
Florida Cancer Specialists
West Palm Beach, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Illinois Cancer Specialists
Niles, Illinois, United States
Siouxland Regional Cancer Center dba June E. Nylen Cancer Center
Sioux City, Iowa, United States
Kansas City VA Medical Center
Westwood, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Maryland Oncology Hematology, P.A.
Clinton, Maryland, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States
Park Nicollet Frauenshuh Cancer Center
Saint Paul, Minnesota, United States
Nebraska Hematology - Oncology
Lincoln, Nebraska, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States
Broome Oncology, LLC
Johnson City, New York, United States
Stony Brook Cancer Center
Stony Brook, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, United States
W.G (Bill) Hefner VAMC
Salisbury, North Carolina, United States
Zangmeister Cancer Center
Columbus, Ohio, United States
Tennessee Oncology, PLLC
Chattanooga, Tennessee, United States
Baptist Clinical Research Institute
Memphis, Tennessee, United States
Texas Oncology - Bedford
Bedford, Texas, United States
Texas Oncology - Denison
Denison, Texas, United States
Texas Oncology - Denton South
Denton, Texas, United States
Texas Oncology Cancer Care and Research Center
McAllen, Texas, United States
USOR - Texas Oncology - McKinney
McKinney, Texas, United States
Texas Oncology - Paris
Paris, Texas, United States
Texas Oncology-Plano East
Plano, Texas, United States
Texas Oncology-Plano West
Plano, Texas, United States
Shenandoah Oncology Associates, PC
Winchester, Virginia, United States
University of Wisconsin Clinical Science Center
Madison, Wisconsin, United States
Froedtert Hospital/Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Border Medical Oncology Research Unit
Albury, New South Wales, Australia
Southern Highlands Cancer Centre
Bowral, New South Wales, Australia
St Vincent's Public Hospital
Darlinghurst, New South Wales, Australia
Sunshine Coast University Private Hospital
Birtinya, Queensland, Australia
Gallipoli Medical Research Foundation
Greenslopes, Queensland, Australia
Flinders Medical centre
Bedford Park, South Australia, Australia
Icon Cancer Centre
Hobart, Tasmania, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Health
Clayton, Victoria, Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia
Joondalup Health Campus
Joondalup, Western Australia, Australia
ir Charles Gairdner Hospital
Perth, Western Australia, Australia
Medizinische Universität Innsbruck, Medizinische Universitat Innsbruck, Universitatsklinik fur Innere Medizin V, Hamatologie und Onkolgie
Innsbruck, , Austria
Muellner Hauptstrabe 48
Salzburg, , Austria
zuniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU
Salzburg, , Austria
Klinik Floridsdorf, Karl Landsteiner Institute fur Lungenforschung und Pneumologische onkologie (LFPO) Abteilung Fur Innere Medizin un Pneumologie
Vienna, , Austria
Algemeen Ziekenhuis Klina
Brasschaat, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Algemeen Ziekenhuis Sint-Lucas
Ghent, , Belgium
Az Maria Middelares Ghent
Ghent, , Belgium
CHU Ambroise Pare
Mons, , Belgium
CRIO - Centro Regional Integrado de Oncologia
Fortaleza, , Brazil
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Ijuí, , Brazil
Catatina Pesquisa Clinica - Clinica de Neoplasias Litoral
Itajaí, , Brazil
Centro de Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho
Jaú, , Brazil
Hospital de Clínicas de Porto Alegre - HCPA
Porto Alegre, , Brazil
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa
Porto Alegre, , Brazil
Nucleo de Pesquisa da Rede Sao Camilo-Instituto Brasileiro de controle do cancer-IBC
São Paulo, , Brazil
A Beneficência Portuguesa de São Paulo
São Paulo, , Brazil
Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP
São Paulo, , Brazil
Royal Victoria Regional Health Centre
Barrie, , Canada
William Osler Health System-Brampton Civic Hospital
Brampton, , Canada
McGill University Health Centre
Montreal, , Canada
Required Centre Hospitalier Regional de Rimouski
Rimouski, , Canada
Windsor Regional Hospital Cancer Program
Windsor, , Canada
Institut Sainte Catherine
Avignon, , France
Centre Hospitalier de la Côte Basque
Bayonne, , France
APHP-Hopital Ambroise-Pare
Boulogne-Billancourt, , France
CHU de CAEN
Caen, , France
Centre Francois Baclesse
Calvados, , France
Centre Hospitalier de Chauny
Chauny, , France
CHU-Hopital Gabriel Montpied
Clermont-Ferrand, , France
Centre Hospitalier Intercommunal de Creteil
Créteil, , France
Centre Hospitalier Annecy Genevois
Epagny Metz-tessy, , France
Centre Hospitalier Departemental Vendee
La Roche-sur-Yon, , France
Clinique Victor Hugo
Le Mans, , France
CHU de Lille
Lille, , France
Hopital Dupuytren (CHU de Limoges)
Limoges, , France
Chu Montpellier Hopital Arnaud de Villeneuve
Montpellier, , France
GHR Sud Alsace - Hopital Emile Muller
Mulhouse, , France
Institut Curie
Paris, , France
CHU de Bordeaux Hopital Haut leveque
Pessac, , France
Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud
Pierre-Bénite, , France
CHU de Poitiers
Poitiers, , France
Centre Hospitalier Universitaire de Rouen - Hopitel Charles Nicolle
Rouen, , France
Institut de Cancérologie de l'Ouest - Paysde Loire (site SAINT HERBLAIN)
Saint-Herblain, , France
Hopital Foch
Saint-Herblain, , France
Institut Cancérologie Strasbourg Europe
Strasbourg, , France
CHITS-Hopital Sainte Musse
Toulon, , France
Stadtisches Klinikum Braunschweig gGmbH Medizinische Klinik III Hamatologie und Onkologie
Braunschweig, , Germany
Klinikum Esslingen GmbH Klinik fur Kardiologie,Angiologie und Pneumologie
Esslingen am Neckar, , Germany
Asklepios Klinikum Harburg, Thoraxzentrum Hamburg - Lungenabteilung
Hamburg, , Germany
Studiengeselischaft Hamato-Onkologie Hamburg
Hamburg, , Germany
Onkologische Schwerpunktpraxis Heilbronn
Heilbronn, , Germany
Lungenfachklink Immenhausen
Immenhausen, , Germany
Klinikum Kassel Klinik Für Hämatologie Onkologie Und Immunologie
Kassel, , Germany
Universitatsklinikum Schleswig-Holstein - Campus Lubeck, Medizinische Klinik III (Studienzentrum Pneumologie)
Lübeck, , Germany
University Hospital Mannheim, Department of Personalized Medical Oncology with Section Thoracic Oncology
Mannheim, , Germany
Asklepios-Fachkliniken Munchen-Gauting, Zentrum fur Pneumologie und Thoraxchirurgie
Munchen-Gauting, , Germany
Sana Klinikum Offenbach, Medizinische Klinik IV fur Hamatologie und internistische Onkologie
Offenbach, , Germany
Henry Dunant Hospital Center, 4th Oncology Department
Athens, , Greece
General Hospital of Chest Diseases "I Sotiria", 3rd Internal Medicine Department of Athens University - Oncology Unit
Athens, , Greece
Metropolitan General, Oncology department
Cholargós, , Greece
General Oncology Hospital of Kifisia "Agioi Anargyroi", 2nd Department of Medical Oncology
Heraklion, , Greece
University General Hospital of Larissa, Oncology Department-1St Internal Medical Division
Larissa, , Greece
General Oncology Hospital of Kifisia "Agioi Anargyroi", 2nd Department of Medical Oncology
Nea Kifissia, , Greece
Euromedica General Clinic of Thessaloniki
Thessaloniki, , Greece
Interbalkan Medical Center of Thessaloniki
Thessaloniki, , Greece
Samson Assuta Ashdod University Hospital
Ashdod, , Israel
Soroka Medical Center
Beersheba, , Israel
Hadassah University Hospital Ein Kerem
Jerusalem, , Israel
Kaplan Medical Center
Rehovot, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Shamir Medical Center (Assaf Harofeh)
Tzrifin, , Israel
ASST Papa Giovanni XXIII, Oncologia Medica
Bergamo, , Italy
Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia
Brescia, , Italy
AOU Policlinico G Rodlico-Oncologia Medica
Catania, , Italy
AOU mater Domini, UOC Oncologia Medica e Oncologia Medica Trazionale
Catanzaro, , Italy
ASST Cremona
Cremona, , Italy
Instituto Europeo di Oncologia
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda SC Oncologia
Milan, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Fondazione Policlinico Universitario Campus Bio-Medico, UOC Oncologia Medica
Roma, , Italy
UOC Oncologia
San Giovanni Rotondo, , Italy
ASST Bergamo Ovest- ospedale di Treviglio-u.o. Oncologia
Treviglio, , Italy
SC Oncologia -ASST SETTE LAGHI
Varese, , Italy
National Hospital Organization Asahikawa Medical Center
Asahikawa, , Japan
National Cancer Center Hospital
Chūō, , Japan
Fukui Prefectural Hospital
Fukui, , Japan
Kansai Medical University Hospital
Hirakata, , Japan
Hiroshima University Hospital
Hiroshima, , Japan
Kobe City Medical Center General Hospital
Hyōgo, , Japan
National Hospital Organization Himeji Medical Center
Hyōgo, , Japan
Nippon Medical School Chiba Hokusoh Hospital
Inzai, , Japan
National Hospital Organization Iwakuni Clinical Center
Iwakuni, , Japan
Kagoshima University Hospital
Kagoshima, , Japan
Kanagawa Prefectural Hospital Organization Kanagawa Cardiovascular and Respiratory Center
Kanagawaken, , Japan
Kanazawa University Hospital
Kanazawa, , Japan
National Cancer Center Hospital East
Kashiwa, , Japan
Saitama Cancer Center
Kitaadachi-gun, , Japan
The Cancer Institute Hospital of JFCR
Kōtō City, , Japan
Kurume University Hospital
Kurume, , Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, , Japan
Shikoku Cancer Center
Matsuyama, , Japan
Miyagi Cancer Center
Miyagi, , Japan
Nagasaki University Hospital
Nagasaki, , Japan
National Hospital Organization Nagoya Medical Center
Nagoya, , Japan
Niigata Cancer Center Hospital
Niigata, , Japan
Okayama University Hospital
Okayama, , Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
Osaka, , Japan
Kindai University Hospital
Osakasayama-Shi, , Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai, , Japan
Centor Hospital of the National Center for Global Health and Medicine
Shinjuku-Ku, , Japan
Shizuoka Cancer Center
Sunto-gun, , Japan
National Hospital Organization Osaka Toneyama Medical Center
Toyonaka, , Japan
Tochigi Cancer Center
Utsunomiya, , Japan
Japanese Red Cross Wakayama Medical Center
Wakayama, , Japan
Yokohama Municipal Citizen's Hospital
Yokohama, , Japan
Kanagawa Cancer Center
Yokohama, , Japan
Tottori University Hospital
Yonago, , Japan
Panamerican Clinical Research S.A. de C.V
Guadalajara, , Mexico
Actualidad Basada en la Investigación del Cáncer
Guadalajara, , Mexico
Cryptex Investigación Clínica, S.A. de C.V.
Mexico City, , Mexico
Amphia Hospital
Breda, , Netherlands
Maastricht Universitair Medisch Centrum
Maastricht, , Netherlands
Erasmus MC
Rotterrdam, , Netherlands
Haaglanden Medical Centre
The Hague, , Netherlands
Elisabeth-TweeSteden Ziekenhuis (ETZ)
Tilburg, , Netherlands
Przychodnia Lekarska Komed Roman Karaszewski
Konin, , Poland
Instytut MSF Sp. z o.o.
Lodz, , Poland
Centrum Medyczne Mrukmed
Rzeszáw, , Poland
Marzowiecki Szpital Wojewodzki sw Jana Pawla II Wsiedicach sp. z.o.o Siedickie centrum onkoiogii
Siedlce, , Poland
Instituto Português de Oncologia de Coimbra Francisco Gentil
Coimbra, , Portugal
Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido Valente
Lisbon, , Portugal
Fundacao Champalimaud
Lisbon, , Portugal
Senhora da Hora
Matosinhos Municipality, , Portugal
Hospital CUF Porto
Porto, , Portugal
Centro Hospitalar Universitario do Porto
Porto, , Portugal
Instituto Portugues de Oncologia do Porto
Porto, , Portugal
Pan American Center For Oncology Trials, LLC
San Juan, PR, Puerto Rico
Ad-Vance Medical Research, LLC
Ponce, , Puerto Rico
Complejo Hospitalario Universitario A Coruna. Hospital Teresa Herrera
A Coruña, , Spain
Institut Catala d'Oncologia Badalona, ICO Badalona, Hospital Germans Trias i Pujol
Badalona, , Spain
Hospital Universitario Cruces
Barakaldo, , Spain
Hospital Universitari Dexeus
Barcelona, , Spain
Hospital Universitario Vall D'Hebron
Barcelona, , Spain
Institut Catala D'Oncologia (ICO L'Hospitalet) Hospital Duran i Reynals
Barcelona, , Spain
Hospital San Pedro de Alcantara
Cáceres, , Spain
Institut Catala d'Oncologia de Girona
Girona, , Spain
Hospital Universitario de la Princesa
Madrid, , Spain
Hospital Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Dias
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Clinical San Carlos
Madrid, , Spain
Hospital Universitario 12 Octubre
Madrid, , Spain
Hospital universitario la paz
Madrid, , Spain
Hospital Regional Universitario de Malaga-Hospital Civil
Málaga, , Spain
Hospital Clinicl universitario virgen de la Arrixaca
Murcia, , Spain
Clinica Universidad de Navarra-Pamplona
Pamplona, , Spain
Hospital de Sabadell
Sabadell, , Spain
Hospital Virgen de Valme
Seville, , Spain
Hospital universitario Virgen Macarena
Seville, , Spain
Hospital Universitario la Fe
Valencia, , Spain
Hacettepe Üniversitesi Hastanesi
Ankara, , Turkey (Türkiye)
Memorial Ankara Hastane
Ankara, , Turkey (Türkiye)
Acibadem Bursa Hastanesi
Bursa, , Turkey (Türkiye)
Ankara Sehir Hastanesi
Dikimevi- Ankara, , Turkey (Türkiye)
Trakya Üniversitesi Sağlık Araştırma ve Uygulama Merkezi
Edirne, , Turkey (Türkiye)
Bagcilar Medipol Mega Universite Hastanesi
Istanbul, , Turkey (Türkiye)
T.C. Saglik Bakanligi Goztepe Prof. Dr Suleyman Yalcin Sehir Hastanesi
Kadıköy, , Turkey (Türkiye)
Acibadem Maslak Hastanesi
Sarıyer, , Turkey (Türkiye)
Gazi Universitesi Gazi Hastanesi
Yenimahalle, , Turkey (Türkiye)
University Hospital Birmingham NHS Trust, Birmingham Heartlands Hospital
Birmingham, , United Kingdom
East Suffolk and North Essex NHS Foundation Trust
Colchester, , United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
St James University Hospital
Leeds, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Barts Health NHS Trust
London, , United Kingdom
The Christie NHS Foundation
Manchester, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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jRCT2051220119
Identifier Type: REGISTRY
Identifier Source: secondary_id
2024-512148-50
Identifier Type: OTHER
Identifier Source: secondary_id
GS-US-577-6153
Identifier Type: -
Identifier Source: org_study_id
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