NCT05089734

Brief 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).

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Strong global presence with extensive site network
Enrollment
603

participants targeted

Target at P75+ for phase_3 nonsmall-cell-lung-cancer

Timeline
Completed

Started Nov 2021

Geographic Reach
19 countries

215 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
26 days until next milestone

Study Start

First participant enrolled

November 17, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 14, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

May 23, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

October 11, 2021

Results QC Date

November 27, 2024

Last Update Submit

May 13, 2025

Conditions

Outcome Measures

Primary Outcomes (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.

    Up to 24.4 months

Secondary Outcomes (8)

  • Progression-free Survival (PFS) Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

    Up to 24.4 months

  • Objective Response Rate (ORR) Assessed by Investigator Per RECIST Version 1.1

    Up to 24.4 months

  • Duration of Response (DOR) Assessed by Investigator Per RECIST Version 1.1

    Up to 24.4 months

  • Disease Control Rate (DCR) Assessed by Investigator Per RECIST Version 1.1

    Up to 24.4 months

  • Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs)

    Up to 3.5 years

  • +3 more secondary outcomes

Study Arms (2)

Sacituzumab Govitecan-hziy (SG)

EXPERIMENTAL

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)

Docetaxel

ACTIVE COMPARATOR

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

Interventions

Administered intravenously

Also known as: IMMU-132, GS-0132
Sacituzumab Govitecan-hziy (SG)

Administered intravenously

Docetaxel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (227)

Alaska Oncology and Hematology, LLC.

Anchorage, Alaska, 99508, United States

Location

USOR - Arizona Oncology Associates Tucson - Wilmot

Tucson, Arizona, 85711, United States

Location

Beverly Hills Cancer Center

Beverly Hills, California, 90211, United States

Location

Rocky Mountain Cancer Centers - Aurora

Aurora, Colorado, 80012, United States

Location

Florida Cancer Specialists (Administration and Drug Shipment)

Fort Myers, Florida, 33901, United States

Location

Woodlands Medical Specialists, PA

Pensacola, Florida, 32503, United States

Location

Florida Cancer Specialists

St. Petersburg, Florida, 33705, United States

Location

Florida Cancer Specialists

West Palm Beach, Florida, 33401, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60607, United States

Location

Illinois Cancer Specialists

Niles, Illinois, 60714, United States

Location

Siouxland Regional Cancer Center dba June E. Nylen Cancer Center

Sioux City, Iowa, 51101, United States

Location

Kansas City VA Medical Center

Westwood, Kansas, 66205, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Maryland Oncology Hematology, P.A.

Clinton, Maryland, 20735, United States

Location

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States

Location

Park Nicollet Frauenshuh Cancer Center

Saint Paul, Minnesota, 55101, United States

Location

Nebraska Hematology - Oncology

Lincoln, Nebraska, 68506, United States

Location

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, 89052, United States

Location

Broome Oncology, LLC

Johnson City, New York, 13790, United States

Location

Stony Brook Cancer Center

Stony Brook, New York, 11794, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

FirstHealth Outpatient Cancer Center

Pinehurst, North Carolina, 28374, United States

Location

W.G (Bill) Hefner VAMC

Salisbury, North Carolina, 28144, United States

Location

Zangmeister Cancer Center

Columbus, Ohio, 43219, United States

Location

Tennessee Oncology, PLLC

Chattanooga, Tennessee, 37404, United States

Location

Baptist Clinical Research Institute

Memphis, Tennessee, 38120, United States

Location

Texas Oncology - Bedford

Bedford, Texas, 76022, United States

Location

Texas Oncology - Denison

Denison, Texas, 75020, United States

Location

Texas Oncology - Denton South

Denton, Texas, 76201, United States

Location

Texas Oncology Cancer Care and Research Center

McAllen, Texas, 78503, United States

Location

USOR - Texas Oncology - McKinney

McKinney, Texas, 75071, United States

Location

Texas Oncology - Paris

Paris, Texas, 75460, United States

Location

Texas Oncology-Plano East

Plano, Texas, 75075, United States

Location

Texas Oncology-Plano West

Plano, Texas, 75093, United States

Location

Shenandoah Oncology Associates, PC

Winchester, Virginia, 22601, United States

Location

University of Wisconsin Clinical Science Center

Madison, Wisconsin, 53792, United States

Location

Froedtert Hospital/Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Border Medical Oncology Research Unit

Albury, New South Wales, 2640, Australia

Location

Southern Highlands Cancer Centre

Bowral, New South Wales, 2576, Australia

Location

St Vincent's Public Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

Sunshine Coast University Private Hospital

Birtinya, Queensland, 4575, Australia

Location

Gallipoli Medical Research Foundation

Greenslopes, Queensland, 4120, Australia

Location

Flinders Medical centre

Bedford Park, South Australia, 5042, Australia

Location

Icon Cancer Centre

Hobart, Tasmania, 7000, Australia

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

Monash Health

Clayton, Victoria, 3168, Australia

Location

Peninsula & South Eastern Haematology and Oncology Group

Frankston, Victoria, 3199, Australia

Location

Joondalup Health Campus

Joondalup, Western Australia, 6027, Australia

Location

ir Charles Gairdner Hospital

Perth, Western Australia, 6009, Australia

Location

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

Innsbruck, 06020, Austria

Location

Muellner Hauptstrabe 48

Salzburg, 5020, Austria

Location

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

Salzburg, A-5020, Austria

Location

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

Vienna, 1210, Austria

Location

Algemeen Ziekenhuis Klina

Brasschaat, 2930, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

Algemeen Ziekenhuis Sint-Lucas

Ghent, 9000, Belgium

Location

Az Maria Middelares Ghent

Ghent, 9000, Belgium

Location

CHU Ambroise Pare

Mons, 7000, Belgium

Location

CRIO - Centro Regional Integrado de Oncologia

Fortaleza, 60810180, Brazil

Location

ONCOSITE - Centro de Pesquisa Clinica em Oncologia

Ijuí, 98700-000, Brazil

Location

Catatina Pesquisa Clinica - Clinica de Neoplasias Litoral

Itajaí, 88331-10, Brazil

Location

Centro de Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho

Jaú, 17210080, Brazil

Location

Hospital de Clínicas de Porto Alegre - HCPA

Porto Alegre, 90035903, Brazil

Location

Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa

Porto Alegre, 90110-270, Brazil

Location

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

São Paulo, 03102002, Brazil

Location

A Beneficência Portuguesa de São Paulo

São Paulo, Brazil

Location

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

São Paulo, Brazil

Location

Royal Victoria Regional Health Centre

Barrie, L4M 6M2, Canada

Location

William Osler Health System-Brampton Civic Hospital

Brampton, L6R 3J7, Canada

Location

McGill University Health Centre

Montreal, H4A 3J1, Canada

Location

Required Centre Hospitalier Regional de Rimouski

Rimouski, G5L5T1, Canada

Location

Windsor Regional Hospital Cancer Program

Windsor, N8W 2X3, Canada

Location

Institut Sainte Catherine

Avignon, 84918, France

Location

Centre Hospitalier de la Côte Basque

Bayonne, 64100, France

Location

APHP-Hopital Ambroise-Pare

Boulogne-Billancourt, 92100, France

Location

CHU de CAEN

Caen, 14033, France

Location

Centre Francois Baclesse

Calvados, 14076 CEDEX 05, France

Location

Centre Hospitalier de Chauny

Chauny, 02300, France

Location

CHU-Hopital Gabriel Montpied

Clermont-Ferrand, 63000, France

Location

Centre Hospitalier Intercommunal de Creteil

Créteil, 94010, France

Location

Centre Hospitalier Annecy Genevois

Epagny Metz-tessy, 74374, France

Location

Centre Hospitalier Departemental Vendee

La Roche-sur-Yon, 85925, France

Location

Clinique Victor Hugo

Le Mans, 72000, France

Location

CHU de Lille

Lille, 59000, France

Location

Hopital Dupuytren (CHU de Limoges)

Limoges, 87042, France

Location

Chu Montpellier Hopital Arnaud de Villeneuve

Montpellier, 34295 CEDEX, France

Location

GHR Sud Alsace - Hopital Emile Muller

Mulhouse, 68100, France

Location

Institut Curie

Paris, France

Location

CHU de Bordeaux Hopital Haut leveque

Pessac, 33600, France

Location

Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud

Pierre-Bénite, 69495, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

Centre Hospitalier Universitaire de Rouen - Hopitel Charles Nicolle

Rouen, 76031, France

Location

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

Saint-Herblain, 44805, France

Location

Hopital Foch

Saint-Herblain, France

Location

Institut Cancérologie Strasbourg Europe

Strasbourg, 67033, France

Location

CHITS-Hopital Sainte Musse

Toulon, 83056, France

Location

Stadtisches Klinikum Braunschweig gGmbH Medizinische Klinik III Hamatologie und Onkologie

Braunschweig, 38114, Germany

Location

Klinikum Esslingen GmbH Klinik fur Kardiologie,Angiologie und Pneumologie

Esslingen am Neckar, 73730, Germany

Location

Asklepios Klinikum Harburg, Thoraxzentrum Hamburg - Lungenabteilung

Hamburg, 21075, Germany

Location

Studiengeselischaft Hamato-Onkologie Hamburg

Hamburg, Germany

Location

Onkologische Schwerpunktpraxis Heilbronn

Heilbronn, 74245, Germany

Location

Lungenfachklink Immenhausen

Immenhausen, 34376, Germany

Location

Klinikum Kassel Klinik Für Hämatologie Onkologie Und Immunologie

Kassel, 34125, Germany

Location

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

Lübeck, 23538, Germany

Location

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

Mannheim, 68167, Germany

Location

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

Munchen-Gauting, 82131, Germany

Location

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

Offenbach, 63069, Germany

Location

Henry Dunant Hospital Center, 4th Oncology Department

Athens, 11526, Greece

Location

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

Athens, 11527, Greece

Location

Metropolitan General, Oncology department

Cholargós, 15562, Greece

Location

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

Heraklion, Greece

Location

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

Larissa, 413 34, Greece

Location

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

Nea Kifissia, 14565, Greece

Location

Euromedica General Clinic of Thessaloniki

Thessaloniki, 54645, Greece

Location

Interbalkan Medical Center of Thessaloniki

Thessaloniki, 555 35, Greece

Location

Samson Assuta Ashdod University Hospital

Ashdod, 7747629, Israel

Location

Soroka Medical Center

Beersheba, 84101, Israel

Location

Hadassah University Hospital Ein Kerem

Jerusalem, Israel

Location

Kaplan Medical Center

Rehovot, 76100, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Shamir Medical Center (Assaf Harofeh)

Tzrifin, Israel

Location

ASST Papa Giovanni XXIII, Oncologia Medica

Bergamo, 24127, Italy

Location

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

Brescia, 25123, Italy

Location

AOU Policlinico G Rodlico-Oncologia Medica

Catania, 95125, Italy

Location

AOU mater Domini, UOC Oncologia Medica e Oncologia Medica Trazionale

Catanzaro, 88100, Italy

Location

ASST Cremona

Cremona, 26100, Italy

Location

Instituto Europeo di Oncologia

Milan, 20141, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda SC Oncologia

Milan, 20162, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Fondazione Policlinico Universitario Campus Bio-Medico, UOC Oncologia Medica

Roma, 00128, Italy

Location

UOC Oncologia

San Giovanni Rotondo, 71013, Italy

Location

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

Treviglio, 24047, Italy

Location

SC Oncologia -ASST SETTE LAGHI

Varese, 21100, Italy

Location

National Hospital Organization Asahikawa Medical Center

Asahikawa, 070-8644, Japan

Location

National Cancer Center Hospital

Chūō, 104-0045, Japan

Location

Fukui Prefectural Hospital

Fukui, 910-8526, Japan

Location

Kansai Medical University Hospital

Hirakata, 573-1191, Japan

Location

Hiroshima University Hospital

Hiroshima, 734-8551, Japan

Location

Kobe City Medical Center General Hospital

Hyōgo, 650-0047, Japan

Location

National Hospital Organization Himeji Medical Center

Hyōgo, 670-8520, Japan

Location

Nippon Medical School Chiba Hokusoh Hospital

Inzai, 270-1694, Japan

Location

National Hospital Organization Iwakuni Clinical Center

Iwakuni, 740-8510, Japan

Location

Kagoshima University Hospital

Kagoshima, 8908520, Japan

Location

Kanagawa Prefectural Hospital Organization Kanagawa Cardiovascular and Respiratory Center

Kanagawaken, 236-0051, Japan

Location

Kanazawa University Hospital

Kanazawa, 920-8641, Japan

Location

National Cancer Center Hospital East

Kashiwa, 277-8577, Japan

Location

Saitama Cancer Center

Kitaadachi-gun, 362-0806, Japan

Location

The Cancer Institute Hospital of JFCR

Kōtō City, 135-8550, Japan

Location

Kurume University Hospital

Kurume, 830-0011, Japan

Location

University Hospital Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

Location

Shikoku Cancer Center

Matsuyama, 791-0280, Japan

Location

Miyagi Cancer Center

Miyagi, 981-1293, Japan

Location

Nagasaki University Hospital

Nagasaki, 852-8501, Japan

Location

National Hospital Organization Nagoya Medical Center

Nagoya, 460-0001, Japan

Location

Niigata Cancer Center Hospital

Niigata, 951-8566, Japan

Location

Okayama University Hospital

Okayama, 700-8558, Japan

Location

Osaka Prefectural Hospital Organization Osaka International Cancer Institute

Osaka, 541-8567, Japan

Location

Kindai University Hospital

Osakasayama-Shi, 589-8511, Japan

Location

National Hospital Organization Kinki-Chuo Chest Medical Center

Sakai, 591-8555, Japan

Location

Centor Hospital of the National Center for Global Health and Medicine

Shinjuku-Ku, 162-8655, Japan

Location

Shizuoka Cancer Center

Sunto-gun, 411-8777, Japan

Location

National Hospital Organization Osaka Toneyama Medical Center

Toyonaka, 560-8552, Japan

Location

Tochigi Cancer Center

Utsunomiya, 320-0834, Japan

Location

Japanese Red Cross Wakayama Medical Center

Wakayama, 640-8558, Japan

Location

Yokohama Municipal Citizen's Hospital

Yokohama, 221-0855, Japan

Location

Kanagawa Cancer Center

Yokohama, 241-8515, Japan

Location

Tottori University Hospital

Yonago, 683-8504, Japan

Location

Panamerican Clinical Research S.A. de C.V

Guadalajara, 44670, Mexico

Location

Actualidad Basada en la Investigación del Cáncer

Guadalajara, Mexico

Location

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

Mexico City, 06100, Mexico

Location

Amphia Hospital

Breda, 4818 CK, Netherlands

Location

Maastricht Universitair Medisch Centrum

Maastricht, 6229 HX, Netherlands

Location

Erasmus MC

Rotterrdam, 3015, Netherlands

Location

Haaglanden Medical Centre

The Hague, 2262BA, Netherlands

Location

Elisabeth-TweeSteden Ziekenhuis (ETZ)

Tilburg, 5022, Netherlands

Location

Przychodnia Lekarska Komed Roman Karaszewski

Konin, 62-500, Poland

Location

Instytut MSF Sp. z o.o.

Lodz, 90-302, Poland

Location

Centrum Medyczne Mrukmed

Rzeszáw, 35-085, Poland

Location

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

Siedlce, 08-110, Poland

Location

Instituto Português de Oncologia de Coimbra Francisco Gentil

Coimbra, 3000-075, Portugal

Location

Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido Valente

Lisbon, 1769-001, Portugal

Location

Fundacao Champalimaud

Lisbon, Portugal

Location

Senhora da Hora

Matosinhos Municipality, 4464-513, Portugal

Location

Hospital CUF Porto

Porto, 14341, Portugal

Location

Centro Hospitalar Universitario do Porto

Porto, 4099-001, Portugal

Location

Instituto Portugues de Oncologia do Porto

Porto, 4200-072, Portugal

Location

Pan American Center For Oncology Trials, LLC

San Juan, PR, 00902, Puerto Rico

Location

Ad-Vance Medical Research, LLC

Ponce, 00717, Puerto Rico

Location

Complejo Hospitalario Universitario A Coruna. Hospital Teresa Herrera

A Coruña, 15006, Spain

Location

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

Badalona, 08916, Spain

Location

Hospital Universitario Cruces

Barakaldo, 48903, Spain

Location

Hospital Universitari Dexeus

Barcelona, 08028, Spain

Location

Hospital Universitario Vall D'Hebron

Barcelona, 08035, Spain

Location

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

Barcelona, 08908, Spain

Location

Hospital San Pedro de Alcantara

Cáceres, 10004, Spain

Location

Institut Catala d'Oncologia de Girona

Girona, 17007, Spain

Location

Hospital Universitario de la Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario Fundacion Jimenez Dias

Madrid, 28020, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Clinical San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 Octubre

Madrid, 28041, Spain

Location

Hospital universitario la paz

Madrid, 28046, Spain

Location

Hospital Regional Universitario de Malaga-Hospital Civil

Málaga, 29010, Spain

Location

Hospital Clinicl universitario virgen de la Arrixaca

Murcia, 30120, Spain

Location

Clinica Universidad de Navarra-Pamplona

Pamplona, 31008, Spain

Location

Hospital de Sabadell

Sabadell, 8208, Spain

Location

Hospital Virgen de Valme

Seville, 41001, Spain

Location

Hospital universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Universitario la Fe

Valencia, 46026, Spain

Location

Hacettepe Üniversitesi Hastanesi

Ankara, 06230, Turkey (Türkiye)

Location

Memorial Ankara Hastane

Ankara, 06520, Turkey (Türkiye)

Location

Acibadem Bursa Hastanesi

Bursa, 16059, Turkey (Türkiye)

Location

Ankara Sehir Hastanesi

Dikimevi- Ankara, 06100, Turkey (Türkiye)

Location

Trakya Üniversitesi Sağlık Araştırma ve Uygulama Merkezi

Edirne, Turkey (Türkiye)

Location

Bagcilar Medipol Mega Universite Hastanesi

Istanbul, Turkey (Türkiye)

Location

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

Kadıköy, Turkey (Türkiye)

Location

Acibadem Maslak Hastanesi

Sarıyer, Turkey (Türkiye)

Location

Gazi Universitesi Gazi Hastanesi

Yenimahalle, Turkey (Türkiye)

Location

University Hospital Birmingham NHS Trust, Birmingham Heartlands Hospital

Birmingham, B9 5SS, United Kingdom

Location

East Suffolk and North Essex NHS Foundation Trust

Colchester, CO4 5JL, United Kingdom

Location

The Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

St James University Hospital

Leeds, LS9 7TF, United Kingdom

Location

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

Barts Health NHS Trust

London, EC1A 7BE, United Kingdom

Location

The Christie NHS Foundation

Manchester, M20 4BX, United Kingdom

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

sacituzumab govitecanDocetaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Results Point of Contact

Title
Gilead Clinical Study Information Center
Organization
Gilead Sciences

Study Officials

  • Gilead Study Director

    Gilead Sciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2021

First Posted

October 22, 2021

Study Start

November 17, 2021

Primary Completion

November 29, 2023

Study Completion

January 1, 2026

Last Updated

May 23, 2025

Results First Posted

January 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations