Lung Cancer Clinical Trial

Study of Sacituzumab Govitecan-hziy (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-programmed Death Protein 1 (PD-1)/Programmed Death Ligand 1 (PD-L1) Immunotherapy

Summary

The primary objective of this study is to compare overall survival (OS) of sacituzumab govitecan-hziy (SG) versus docetaxel in participants with advanced or metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy and anti-programmed death protein 1 (PD-1)/ programmed death ligand 1 (PD-L1) immunotherapy received either in combination or sequentially.

Participants will be randomly assigned in a 1:1 ratio to receive either SG or docetaxel.

View Eligibility Criteria

Eligibility Criteria

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).
Testing for epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and programmed death ligand 1 (PD-L1) is required. Testing for other actionable genomic alterations is recommended and to be performed as per local standard of care and availability of targeted treatment.

Must have progressed after platinum-based chemotherapy in combination with anti-PD-L1 antibody OR platinum-based chemotherapy and anti-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 approved 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.
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 is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

520

Study ID:

NCT05089734

Recruitment Status:

Recruiting

Sponsor:

Gilead Sciences

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There are 159 Locations for this study

See Locations Near You

Alaska Oncology and Hematology, LLC.
Anchorage Alaska, 99508, United States
USOR - Arizona Oncology Associates Tucson - Wilmot
Tucson Arizona, 85711, United States
Beverly Hills Cancer Center
Beverly Hills California, 90211, United States
Rocky Mountain Cancer Centers - Aurora
Aurora Colorado, 80012, United States
Florida Cancer Specialists (Administration and Drug Shipment)
Fort Myers Florida, 33901, United States
Woodlands Medical Specialists, PA
Pensacola Florida, 32503, United States
Florida Cancer Specialists
Saint Petersburg Florida, 33705, United States
Florida Cancer Specialists
West Palm Beach Florida, 33401, United States
University of Chicago Medical Center
Chicago Illinois, 60607, United States
Illinois Cancer Specialists
Niles Illinois, 60714, United States
Siouxland Regional Cancer Center dba June E. Nylen Cancer Center
Sioux City Iowa, 51101, United States
Kansas City VA Medical Center
Westwood Kansas, 66205, United States
Baptist Health Lexington
Lexington Kentucky, 40503, United States
Maryland Oncology Hematology, P.A.
Clinton Maryland, 20735, United States
Lahey Hospital & Medical Center
Burlington Massachusetts, 01805, United States
Park Nicollet Frauenshuh Cancer Center
Saint Paul Minnesota, 55101, United States
Nebraska Hematology - Oncology
Lincoln Nebraska, 68506, United States
Comprehensive Cancer Centers of Nevada
Henderson Nevada, 89052, United States
Broome Oncology, LLC
Johnson City New York, 13790, United States
Stony Brook Cancer Center
Stony Brook New York, 11794, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
FirstHealth Outpatient Cancer Center
Pinehurst North Carolina, 28374, United States
W.G (Bill) Hefner VAMC
Salisbury North Carolina, 28144, United States
Zangmeister Cancer Center
Columbus Ohio, 43219, United States
Tennessee Oncology, PLLC
Chattanooga Tennessee, 37404, United States
Baptist Clinical Research Institute
Memphis Tennessee, 38120, United States
Texas Oncology - Bedford
Bedford Texas, 76022, United States
Texas Oncology - Denison
Denison Texas, 75020, United States
Texas Oncology - Denton South
Denton Texas, 76201, United States
Texas Oncology Cancer Care and Research Center
McAllen Texas, 78503, United States
USOR - Texas Oncology - McKinney
McKinney Texas, 75071, United States
Texas Oncology - Paris
Paris Texas, 75460, United States
Texas Oncology-Plano East
Plano Texas, 75075, United States
Texas Oncology-Plano West
Plano Texas, 75093, United States
Shenandoah Oncology Associates, PC
Winchester Virginia, 22601, United States
University of Wisconsin Clinical Science Center
Madison Wisconsin, 53792, United States
Froedtert Hospital/Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Border Medical Oncology Research Unit
Albury New South Wales, 2640, Australia
Southern Highlands Cancer Centre
Bowral New South Wales, 2576, Australia
St Vincent's Public Hospital
Darlinghurst New South Wales, 2010, Australia
Gallipoli Medical Research Foundation
Greenslopes Queensland, 4120, Australia
Flinders Medical centre
Bedford Park South Australia, 5042, Australia
Icon Cancer Centre
Hobart Tasmania, 7000, Australia
Box Hill Hospital
Box Hill Victoria, 3128, Australia
Monash Health
Clayton Victoria, 3168, Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston Victoria, 3199, Australia
ir Charles Gairdner Hospital
Perth Western Australia, 6009, Australia
Muellner Hauptstrabe 48
Salzburg , 5020, Austria
zuniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU
Salzburg , A-502, Austria
Klinik Floridsdorf, Karl Landsteiner Institute fur Lungenforschung und Pneumologische onkologie (LFPO) Abteilung Fur Innere Medizin un Pneumologie
Vienna , 1210, Austria
Algemeen Ziekenhuis Klina
Brasschaat , 2930, Belgium
Cliniques Universitaires Saint-Luc
Brussels , 1200, Belgium
Universitair Ziekenhuis Antwerpen
Edegem , 2650, Belgium
CHU Ambroise Pare
Mons , 7000, Belgium
CRIO - Centro Regional Integrado de Oncologia
Fortaleza , 60810, Brazil
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Ijui , 98700, Brazil
Catatina Pesquisa Clinica - Clinica de Neoplasias Litoral
Itajai , 88331, Brazil
Centro de Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho
Jau , 17210, Brazil
Hospital de Clínicas de Porto Alegre - HCPA
Porto Alegre , 90035, Brazil
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa
Porto Alegre , 90110, Brazil
Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP
Sao Paolo , , Brazil
Nucleo de Pesquisa da Rede Sao Camilo-Instituto Brasileiro de controle do cancer-IBC
Sao Paulo , 03102, Brazil
A Beneficência Portuguesa de São Paulo
São Paulo , , Brazil
Royal Victoria Regional Health Centre
Barrie , L4M 6, Canada
William Osler Health System-Brampton Civic Hospital
Brampton , L6R 3, Canada
McGill University Health Centre
Montreal , H4A 3, Canada
Required Centre Hospitalier Regional de Rimouski
Rimouski , G5L5T, Canada
Windsor Regional Hospital Cancer Program
Windsor , N8W 2, Canada
Institut Sainte Catherine
Avignon , 84918, France
Centre Hospitalier de la Côte Basque
Bayonne , 64100, France
APHP-Hopital Ambroise-Pare
Boulogne-Billancourt , 92100, France
CHU de CAEN
Caen , 14033, France
Centre Francois Baclesse
Calvados , 14076, France
Centre Hospitalier de Chauny
Chauny , 02300, France
CHU-Hopital Gabriel Montpied
Clermont Ferrand , 63000, France
Centre Hospitalier Intercommunal de Creteil
Creteil , 94010, France
Centre Hospitalier Annecy Genevois
Epagny Metz-tessy , 74374, France
Centre Hospitalier Departemental Vendee
La Roche-sur-Yon , 85925, France
Clinique Victor Hugo
Le Mans , 72000, France
CHU de Lille
Lille , 59000, France
Chu Montpellier Hopital Arnaud de Villeneuve
Montpellier , 34295, France
GHR Sud Alsace - Hopital Emile Muller
Mulhouse , 68100, France
Institut Curie
Paris cedex 05 , , France
Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud
Pierre Benite , 69495, France
Hopital Foch
Saint Herblain , , France
CHITS-Hopital Sainte Musse
Toulon cedex , 83056, France
Stadtisches Klinikum Braunschweig gGmbH Medizinische Klinik III Hamatologie und Onkologie
Braunschweig , 38114, Germany
Klinikum Esslingen GmbH Klinik fur Kardiologie,Angiologie und Pneumologie
Esslingen , 73730, Germany
Asklepios-Fachkliniken Munchen-Gauting,Zentrum fur Pneumologie und Thoraxchirurgie
Gauting , 82131, Germany
Asklepios Klinikum Harburg, Thoraxzentrum Hamburg - Lungenabteilung
Hamburg , 21075, Germany
Studiengeselischaft Hamato-Onkologie Hamburg
Hamburg , , Germany
Onkologische Schwerpunktpraxis Heilbronn
Heilbronn , 74245, Germany
Lungenfachklink Immenhausen
Immenhausen , 34376, Germany
Klinikum Kassel Klinik Für Hämatologie Onkologie Und Immunologie
Kassel , 34125, Germany
University Hospital Mannheim, Department of Personalized Medical Oncology with Section Thoracic Oncology
Mannheim , 68167, Germany
Sana Klinikum Offenbach, Medizinische Klinik IV fur Hamatologie und internistische Onkologie
Offenbach , 63069, Germany
Henry Dunant Hospital Center, 4th Oncology Department
Athens , 11526, Greece
General Hospital of Chest Diseases "I Sotiria", 3rd Internal Medicine Department of Athens University - Oncology Unit
Athens , 11527, Greece
Metropolitan General, Oncology department
Cholargos , 15562, 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
Larisa , 413 3, Greece
General Oncology Hospital of Kifisia "Agioi Anargyroi", 2nd Department of Medical Oncology
NEA Kifissia , 14565, Greece
Euromedica General Clinic of Thessaloniki
Thessaloniki , 54645, Greece
Interbalkan Medical Center of Thessaloniki
Thessaloniki , 555 3, Greece
Soroka Medical Center
Beer Seva , 84101, Israel
Hadassah University Hospital Ein Kerem
Jerusalem , , Israel
Kaplan Medical Center
Rehovot , 76100, Israel
Shamir Medical Center (Assaf Harofeh)
Tzrifin , , Israel
ASST Papa Giovanni XXIII, Oncologia Medica
Bergamo , 24127, Italy
AOU Policlinico G Rodlico-Oncologia Medica
Catania , 95125, Italy
AOU mater Domini, UOC Oncologia Medica e Oncologia Medica Trazionale
Catanzaro , 88100, Italy
ASST Cremona
Cremona , 26100, Italy
Instituto Europeo di Oncologia
Milano , 20141, Italy
ASST Grande Ospedale Metropolitano Niguarda SC Oncologia
Milano , 20162, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia , 27100, Italy
Fondazione Policlinico Universitario Campus Bio-Medico, UOC Oncologia Medica
Roma , 00128, Italy
UOC Oncologia
San Giovanni Rotondo , 71013, Italy
ASST Bergamo Ovest- ospedale di Treviglio-u.o. Oncologia
Treviglio (Bg) , 24047, Italy
SC Oncologia -ASST SETTE LAGHI
Varese , 21100, Italy
National Hospital Organization Himeji Medical Center
Hyogo , 670-8, Japan
The Cancer Institute Hospital of JFCR
Koto , 135-8, Japan
Cryptex Investigación Clínica, S.A. de C.V.
Ciudad de Mexico , 06100, Mexico
Panamerican Clinical Research S.A. de C.V
Guadalajara , 44670, Mexico
Actualidad Basada en la Investigación del Cáncer
Guadalajara , , Mexico
Amphia Hospital
Breda , 4818 , Netherlands
Haaglanden Medical Centre
Den Haag , 2262B, Netherlands
Maastricht Universitair Medisch Centrum
Maastricht , 6229 , Netherlands
Elisabeth-TweeSteden Ziekenhuis (ETZ)
Tilburg , 5022, Netherlands
Przychodnia Lekarska Komed Roman Karaszewski
Konin , 62-50, Poland
Instytut MSF Sp. z o.o.
Lodz , 90-30, Poland
Centrum Medyczne Mrukmed
Rzeszáw , 35-08, Poland
Marzowiecki Szpital Wojewodzki sw Jana Pawla II Wsiedicach sp. z.o.o Siedickie centrum onkoiogii
Siedlce , 08-11, Poland
Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido Valente
Lisboa , 1769-, Portugal
Fundacao Champalimaud
Lisbon , , Portugal
Senhora da Hora
Matosinhos , 4464-, Portugal
Hospital CUF Porto
Porto , 14341, Portugal
Instituto Portugues de Oncologia do Porto
Porto , 4200-, Portugal
Ad-Vance Medical Research, LLC
Ponce , 00717, Puerto Rico
Pan American Center For Oncology Trials, LLC
San Juan , 00902, Puerto Rico
Complejo Hospitalario Universitario A Coruna. Hospital Teresa Herrera
A coruna , 15006, Spain
Institut Catala d'Oncologia Badalona, ICO Badalona, Hospital Germans Trias i Pujol
Badalona , 08916, Spain
Hospital Universitario Cruces
Barakaldo , 48903, Spain
Hospital Universitari Dexeus
Barcelona , 08028, Spain
Hospital Universitario Vall D'Hebron
Barcelona , 08035, Spain
Institut Catala D'Oncologia (ICO L'Hospitalet) Hospital Duran i Reynals
Barcelona , 08908, Spain
Hospital San Pedro de Alcantara
Cáceres , 10004, Spain
Institut Catala d'Oncologia de Girona
Girona , 17007, Spain
Hospital Universitario de la Princesa
Madrid , 28006, Spain
Hospital Universitario Gregorio Marañón
Madrid , 28007, Spain
Hospital Universitario Fundacion Jimenez Dias
Madrid , 28020, Spain
Hospital Universitario Ramón y Cajal
Madrid , 28034, Spain
Hospital Clinical San Carlos
Madrid , 28040, Spain
Hospital Universitario 12 Octubre
Madrid , 28041, Spain
Hospital universitario la paz
Madrid , 28046, Spain
Hospital Regional Universitario de Malaga-Hospital Civil
Malaga , 29010, Spain
Hospital Clinicl universitario virgen de la Arrixaca
Murcia , 30120, Spain
Clinica Universidad de Navarra-Pamplona
Pamplona , 31008, Spain
Hospital de Sabadell
Sabadell , 8208, Spain
Hospital Virgen de Valme
Sevilla , 41001, Spain
Hospital universitario Virgen Macarena
Sevilla , 41009, Spain
Hospital Universitario la Fe
Valencia , 46026, Spain
Memorial Ankara Hastane
Ankara , 06520, Turkey
Acibadem Bursa Hastanesi
Bursa , 16059, Turkey
Ankara Sehir Hastanesi
Dikimevi- Ankara , 06100, Turkey
Trakya Üniversitesi Sağlık Araştırma ve Uygulama Merkezi
Edirne , , Turkey
Bagcilar Medipol Mega Universite Hastanesi
Istanbul , , Turkey
T.C. Saglik Bakanligi Goztepe Prof. Dr Suleyman Yalcin Sehir Hastanesi
Kadikoy , , Turkey
Acibadem Maslak Hastanesi
Sariyer , , Turkey
Gazi Universitesi Gazi Hastanesi
Yenimahalle , , Turkey
University Hospital Birmingham NHS Trust, Birmingham Heartlands Hospital
Birmingham , B9 5S, United Kingdom
East Suffolk and North Essex NHS Foundation Trust
Colchester , CO4 5, United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow , G12 0, United Kingdom
St James University Hospital
Leeds , LS9 7, United Kingdom
Leicester Royal Infirmary
Leicester , LE1 5, United Kingdom
Barts Health NHS Trust
London , EC1A , United Kingdom
The Christie NHS Foundation
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

520

Study ID:

NCT05089734

Recruitment Status:

Recruiting

Sponsor:


Gilead Sciences

How clear is this clinincal trial information?

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