Clinical trial NCT05089734: Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2021-10-22
Enrollment: 603
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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).
* Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and programmed death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) results are required. Testing prior to enrollment. Resulting for other actionable genomic alterations is recommended and to be performed as per local standard of care and availability of targeted treatment. For patients with squamous cell carcinoma, EGFR and ALK testing is optional.
* Must have progressed after platinum-based chemotherapy in combination with anti-PD-1/PD-L1 antibody OR platinum-based chemotherapy and anti-PD-1/PD-L1 antibody (in either order) sequentially.

  * No additional treatments are allowed in the recurrent/metastatic setting for individuals with no actionable genomic alterations.
  * Individuals with EGFR, ALK, or any other known actionable genomic alterations must have also received treatment with at least 1 locally approved and available tyrosine kinase inhibitor 1(TKI) appropriate to the genomic alteration.
  * Documented radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.
* Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by the investigator in accordance with per RECIST Version 1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 before randomization.
* Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g/dL, absolute neutrophil count ≥ 1500/mm\^3, and platelets ≥ 100,000/μL).
* Adequate hepatic function (bilirubin ≤ 1.5 x upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase ≤ 2.5 ULN or ≤ 5 x ULN if known liver metastases, and serum albumin \> 3 g/dL).
* Creatinine clearance of at least 30 mL/min as assessed by the Cockcroft-Gault equation.
* Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.

Key Exclusion Criteria:

* Mixed small-cell lung cancer and NSCLC histology.
* Positive serum pregnancy test or women who are lactating.
* Received a prior anticancer biologic agent within 4 weeks prior to enrollment or have received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to enrollment and have not recovered (ie, \> Grade 2 is considered not recovered) from adverse events (AEs) at the time of study entry. Individuals participating in observational studies are eligible.
* Have not recovered (ie, \> Grade 2 is considered not recovered) from AEs due to a previously administered agent.
* Previously received treatment with any of the following:

  * Topoisomerase 1 inhibitors. Any agent including an antibody-drug conjugate (ADC) containing a chemotherapeutic agent targeting topoisomerase 1
  * Trop-2-targeted therapy
  * Docetaxel as monotherapy or in combination with other agents
* Active second malignancy
* NSCLC that is eligible for definitive local therapy alone.
* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc); any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren syndrome, sarcoidosis, etc); or prior pneumonectomy.
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Active cardiac disease
* Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months of enrollment.
* Active serious infection requiring antibiotics.
* Positive HIV-1 or HIV-2 antibody with detectable viral load OR taking medications that may interfere with SN-38 metabolism.
* Positive for hepatitis B surface antigen. Individuals who test positive for hepatitis B core antibody will require hepatitis B virus DNA by quantitative polymerase chain reaction for confirmation of active disease.
* Positive hepatitis C antibody and detectable hepatitis C viral load.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 24.4 months
Secondary outcomes:
measure: Progression-free Survival (PFS) Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
timeFrame: Up to 24.4 months
measure: Objective Response Rate (ORR) Assessed by Investigator Per RECIST Version 1.1
timeFrame: Up to 24.4 months
measure: Duration of Response (DOR) Assessed by Investigator Per RECIST Version 1.1
timeFrame: Up to 24.4 months
measure: Disease Control Rate (DCR) Assessed by Investigator Per RECIST Version 1.1
timeFrame: Up to 24.4 months
measure: Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 3.5 years
measure: Percentage of Participants Who Experienced Grade 3 or 4 Treatment Emergent Laboratory Abnormalities Post-Baseline
timeFrame: Up to 3.5 years
measure: Time to First Deterioration in Shortness of Breath Domain as Measured by Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
timeFrame: Up to 24.4 months
measure: Time to First Deterioration in NSCLC-SAQ Total Score
timeFrame: Up to 24.4 months
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Oncology and Hematology, LLC.
state: Alaska
city: Tucson
country: United States
facility: USOR - Arizona Oncology Associates Tucson - Wilmot
state: Arizona
city: Beverly Hills
country: United States
facility: Beverly Hills Cancer Center
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers - Aurora
state: Colorado
city: Fort Myers
country: United States
facility: Florida Cancer Specialists (Administration and Drug Shipment)
state: Florida
city: Pensacola
country: United States
facility: Woodlands Medical Specialists, PA
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Niles
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Sioux City
country: United States
facility: Siouxland Regional Cancer Center dba June E. Nylen Cancer Center
state: Iowa
city: Westwood
country: United States
facility: Kansas City VA Medical Center
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Clinton
country: United States
facility: Maryland Oncology Hematology, P.A.
state: Maryland
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center
state: Massachusetts
city: Saint Paul
country: United States
facility: Park Nicollet Frauenshuh Cancer Center
state: Minnesota
city: Lincoln
country: United States
facility: Nebraska Hematology - Oncology
state: Nebraska
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Johnson City
country: United States
facility: Broome Oncology, LLC
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Cancer Center
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Pinehurst
country: United States
facility: FirstHealth Outpatient Cancer Center
state: North Carolina
city: Salisbury
country: United States
facility: W.G (Bill) Hefner VAMC
state: North Carolina
city: Columbus
country: United States
facility: Zangmeister Cancer Center
state: Ohio
city: Chattanooga
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Memphis
country: United States
facility: Baptist Clinical Research Institute
state: Tennessee
city: Bedford
country: United States
facility: Texas Oncology - Bedford
state: Texas
city: Denison
country: United States
facility: Texas Oncology - Denison
state: Texas
city: Denton
country: United States
facility: Texas Oncology - Denton South
state: Texas
city: McAllen
country: United States
facility: Texas Oncology Cancer Care and Research Center
state: Texas
city: McKinney
country: United States
facility: USOR - Texas Oncology - McKinney
state: Texas
city: Paris
country: United States
facility: Texas Oncology - Paris
state: Texas
city: Plano
country: United States
facility: Texas Oncology-Plano East
state: Texas
city: Plano
country: United States
facility: Texas Oncology-Plano West
state: Texas
city: Winchester
country: United States
facility: Shenandoah Oncology Associates, PC
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin Clinical Science Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert Hospital/Medical College of Wisconsin
state: Wisconsin
city: Albury
country: Australia
facility: Border Medical Oncology Research Unit
state: New South Wales
city: Bowral
country: Australia
facility: Southern Highlands Cancer Centre
state: New South Wales
city: Darlinghurst
country: Australia
facility: St Vincent's Public Hospital
state: New South Wales
city: Birtinya
country: Australia
facility: Sunshine Coast University Private Hospital
state: Queensland
city: Greenslopes
country: Australia
facility: Gallipoli Medical Research Foundation
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical centre
state: South Australia
city: Hobart
country: Australia
facility: Icon Cancer Centre
state: Tasmania
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Frankston
country: Australia
facility: Peninsula & South Eastern Haematology and Oncology Group
state: Victoria
city: Joondalup
country: Australia
facility: Joondalup Health Campus
state: Western Australia
city: Perth
country: Australia
facility: ir Charles Gairdner Hospital
state: Western Australia
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck, Medizinische Universitat Innsbruck, Universitatsklinik fur Innere Medizin V, Hamatologie und Onkolgie
city: Salzburg
country: Austria
facility: Muellner Hauptstrabe 48
city: Salzburg
country: Austria
facility: zuniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU
city: Vienna
country: Austria
facility: Klinik Floridsdorf, Karl Landsteiner Institute fur Lungenforschung und Pneumologische onkologie (LFPO) Abteilung Fur Innere Medizin un Pneumologie
city: Brasschaat
country: Belgium
facility: Algemeen Ziekenhuis Klina
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Gent
country: Belgium
facility: Algemeen Ziekenhuis Sint-Lucas
city: Gent
country: Belgium
facility: Az Maria Middelares Ghent
city: Mons
country: Belgium
facility: CHU Ambroise Pare
city: Fortaleza
country: Brazil
facility: CRIO - Centro Regional Integrado de Oncologia
city: Ijui
country: Brazil
facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia
city: Itajai
country: Brazil
facility: Catatina Pesquisa Clinica - Clinica de Neoplasias Litoral
city: Jau
country: Brazil
facility: Centro de Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre - HCPA
city: Porto Alegre
country: Brazil
facility: Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa
city: Sao Paolo
country: Brazil
facility: Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP
city: Sao Paulo
country: Brazil
facility: Nucleo de Pesquisa da Rede Sao Camilo-Instituto Brasileiro de controle do cancer-IBC
city: São Paulo
country: Brazil
facility: A Beneficência Portuguesa de São Paulo
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre
city: Brampton
country: Canada
facility: William Osler Health System-Brampton Civic Hospital
city: Montreal
country: Canada
facility: McGill University Health Centre
city: Rimouski
country: Canada
facility: Required Centre Hospitalier Regional de Rimouski
city: Windsor
country: Canada
facility: Windsor Regional Hospital Cancer Program
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Bayonne
country: France
facility: Centre Hospitalier de la Côte Basque
city: Boulogne-Billancourt
country: France
facility: APHP-Hopital Ambroise-Pare
city: Caen
country: France
facility: CHU de CAEN
city: Calvados
country: France
facility: Centre Francois Baclesse
city: Chauny
country: France
facility: Centre Hospitalier de Chauny
city: Clermont Ferrand
country: France
facility: CHU-Hopital Gabriel Montpied
city: Creteil
country: France
facility: Centre Hospitalier Intercommunal de Creteil
city: Epagny Metz-tessy
country: France
facility: Centre Hospitalier Annecy Genevois
city: La Roche-sur-Yon
country: France
facility: Centre Hospitalier Departemental Vendee
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Lille
country: France
facility: CHU de Lille
city: Limoges cedex
country: France
facility: Hopital Dupuytren (CHU de Limoges)
city: Montpellier
country: France
facility: Chu Montpellier Hopital Arnaud de Villeneuve
city: Mulhouse
country: France
facility: GHR Sud Alsace - Hopital Emile Muller
city: Paris cedex 05
country: France
facility: Institut Curie
city: Pessac
country: France
facility: CHU de Bordeaux Hopital Haut leveque
city: Pierre Benite
country: France
facility: Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rouen
country: France
facility: Centre Hospitalier Universitaire de Rouen - Hopitel Charles Nicolle
city: saint Herblain
country: France
facility: Institut de Cancérologie de l'Ouest - Paysde Loire (site SAINT HERBLAIN)
city: Saint Herblain
country: France
facility: Hopital Foch
city: Strasbourg
country: France
facility: Institut Cancérologie Strasbourg Europe
city: Toulon cedex
country: France
facility: CHITS-Hopital Sainte Musse
city: Braunschweig
country: Germany
facility: Stadtisches Klinikum Braunschweig gGmbH Medizinische Klinik III Hamatologie und Onkologie
city: Esslingen
country: Germany
facility: Klinikum Esslingen GmbH Klinik fur Kardiologie,Angiologie und Pneumologie
city: Hamburg
country: Germany
facility: Asklepios Klinikum Harburg, Thoraxzentrum Hamburg - Lungenabteilung
city: Hamburg
country: Germany
facility: Studiengeselischaft Hamato-Onkologie Hamburg
city: Heilbronn
country: Germany
facility: Onkologische Schwerpunktpraxis Heilbronn
city: Immenhausen
country: Germany
facility: Lungenfachklink Immenhausen
city: Kassel
country: Germany
facility: Klinikum Kassel Klinik Für Hämatologie Onkologie Und Immunologie
city: Lubeck
country: Germany
facility: Universitatsklinikum Schleswig-Holstein - Campus Lubeck, Medizinische Klinik III (Studienzentrum Pneumologie)
city: Mannheim
country: Germany
facility: University Hospital Mannheim, Department of Personalized Medical Oncology with Section Thoracic Oncology
city: Munchen-Gauting
country: Germany
facility: Asklepios-Fachkliniken Munchen-Gauting, Zentrum fur Pneumologie und Thoraxchirurgie
city: Offenbach
country: Germany
facility: Sana Klinikum Offenbach, Medizinische Klinik IV fur Hamatologie und internistische Onkologie
city: Athens
country: Greece
facility: Henry Dunant Hospital Center, 4th Oncology Department
city: Athens
country: Greece
facility: General Hospital of Chest Diseases "I Sotiria", 3rd Internal Medicine Department of Athens University - Oncology Unit
city: Cholargos
country: Greece
facility: Metropolitan General, Oncology department
city: Heraklion
country: Greece
facility: General Oncology Hospital of Kifisia "Agioi Anargyroi", 2nd Department of Medical Oncology
city: Larisa
country: Greece
facility: University General Hospital of Larissa, Oncology Department-1St Internal Medical Division
city: Nea Kifisia
country: Greece
facility: General Oncology Hospital of Kifisia "Agioi Anargyroi", 2nd Department of Medical Oncology
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic of Thessaloniki
city: Thessaloniki
country: Greece
facility: Interbalkan Medical Center of Thessaloniki
city: Ashdod
country: Israel
facility: Samson Assuta Ashdod University Hospital
city: Beer Seva
country: Israel
facility: Soroka Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital Ein Kerem
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Tzrifin
country: Israel
facility: Shamir Medical Center (Assaf Harofeh)
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII, Oncologia Medica
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia
city: Catania
country: Italy
facility: AOU Policlinico G Rodlico-Oncologia Medica
city: Catanzaro
country: Italy
facility: AOU mater Domini, UOC Oncologia Medica e Oncologia Medica Trazionale
city: Cremona
country: Italy
facility: ASST Cremona
city: Milano
country: Italy
facility: Instituto Europeo di Oncologia
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda SC Oncologia
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico, UOC Oncologia Medica
city: San Giovanni Rotondo
country: Italy
facility: UOC Oncologia
city: Treviglio
country: Italy
facility: ASST Bergamo Ovest- ospedale di Treviglio-u.o. Oncologia
city: Varese
country: Italy
facility: SC Oncologia -ASST SETTE LAGHI
city: Asahikawa
country: Japan
facility: National Hospital Organization Asahikawa Medical Center
city: Chuo
country: Japan
facility: National Cancer Center Hospital
city: Fukui
country: Japan
facility: Fukui Prefectural Hospital
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Hyogo
country: Japan
facility: Kobe City Medical Center General Hospital
city: Hyogo
country: Japan
facility: National Hospital Organization Himeji Medical Center
city: Inzai
country: Japan
facility: Nippon Medical School Chiba Hokusoh Hospital
city: Iwakuni
country: Japan
facility: National Hospital Organization Iwakuni Clinical Center
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kanagawaken
country: Japan
facility: Kanagawa Prefectural Hospital Organization Kanagawa Cardiovascular and Respiratory Center
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center
city: Koto
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Kurume
country: Japan
facility: Kurume University Hospital
city: Kyoto
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Matsuyama
country: Japan
facility: Shikoku Cancer Center
city: Miyagi
country: Japan
facility: Miyagi Cancer Center
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osakasayama-Shi
country: Japan
facility: Kindai University Hospital
city: Osaka
country: Japan
facility: Osaka Prefectural Hospital Organization Osaka International Cancer Institute
city: Sakai
country: Japan
facility: National Hospital Organization Kinki-Chuo Chest Medical Center
city: Shinjuku-Ku
country: Japan
facility: Centor Hospital of the National Center for Global Health and Medicine
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
city: Toyonaka
country: Japan
facility: National Hospital Organization Osaka Toneyama Medical Center
city: Utsunomiya
country: Japan
facility: Tochigi Cancer Center
city: Wakayama
country: Japan
facility: Japanese Red Cross Wakayama Medical Center
city: Yokohama
country: Japan
facility: Yokohama Municipal Citizen's Hospital
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center
city: Yonago
country: Japan
facility: Tottori University Hospital
city: Ciudad de Mexico
country: Mexico
facility: Cryptex Investigación Clínica, S.A. de C.V.
city: Guadalajara
country: Mexico
facility: Panamerican Clinical Research S.A. de C.V
city: Guadalajara
country: Mexico
facility: Actualidad Basada en la Investigación del Cáncer
city: Breda
country: Netherlands
facility: Amphia Hospital
city: Den Haag
country: Netherlands
facility: Haaglanden Medical Centre
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum
city: Rotterrdam
country: Netherlands
facility: Erasmus MC
city: Tilburg
country: Netherlands
facility: Elisabeth-TweeSteden Ziekenhuis (ETZ)
city: Konin
country: Poland
facility: Przychodnia Lekarska Komed Roman Karaszewski
city: Lodz
country: Poland
facility: Instytut MSF Sp. z o.o.
city: Rzeszáw
country: Poland
facility: Centrum Medyczne Mrukmed
city: Siedlce
country: Poland
facility: Marzowiecki Szpital Wojewodzki sw Jana Pawla II Wsiedicach sp. z.o.o Siedickie centrum onkoiogii
city: Coimbra
country: Portugal
facility: Instituto Português de Oncologia de Coimbra Francisco Gentil
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido Valente
city: Lisbon
country: Portugal
facility: Fundacao Champalimaud
city: Matosinhos
country: Portugal
facility: Senhora da Hora
city: Porto
country: Portugal
facility: Hospital CUF Porto
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario do Porto
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia do Porto
city: Ponce
country: Puerto Rico
facility: Ad-Vance Medical Research, LLC
city: San Juan
country: Puerto Rico
facility: Pan American Center For Oncology Trials, LLC
city: A coruna
country: Spain
facility: Complejo Hospitalario Universitario A Coruna. Hospital Teresa Herrera
city: Badalona
country: Spain
facility: Institut Catala d'Oncologia Badalona, ICO Badalona, Hospital Germans Trias i Pujol
city: Barakaldo
country: Spain
facility: Hospital Universitario Cruces
city: Barcelona
country: Spain
facility: Hospital Universitari Dexeus
city: Barcelona
country: Spain
facility: Hospital Universitario Vall D'Hebron
city: Barcelona
country: Spain
facility: Institut Catala D'Oncologia (ICO L'Hospitalet) Hospital Duran i Reynals
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcantara
city: Girona
country: Spain
facility: Institut Catala d'Oncologia de Girona
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Dias
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clinical San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 Octubre
city: Madrid
country: Spain
facility: Hospital universitario la paz
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga-Hospital Civil
city: Murcia
country: Spain
facility: Hospital Clinicl universitario virgen de la Arrixaca
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra-Pamplona
city: Sabadell
country: Spain
facility: Hospital de Sabadell
city: Sevilla
country: Spain
facility: Hospital Virgen de Valme
city: Sevilla
country: Spain
facility: Hospital universitario Virgen Macarena
city: Valencia
country: Spain
facility: Hospital Universitario la Fe
city: Ankara
country: Turkey
facility: Hacettepe Üniversitesi Hastanesi
city: Ankara
country: Turkey
facility: Memorial Ankara Hastane
city: Bursa
country: Turkey
facility: Acibadem Bursa Hastanesi
city: Dikimevi- Ankara
country: Turkey
facility: Ankara Sehir Hastanesi
city: Edirne
country: Turkey
facility: Trakya Üniversitesi Sağlık Araştırma ve Uygulama Merkezi
city: Istanbul
country: Turkey
facility: Bagcilar Medipol Mega Universite Hastanesi
city: Kadikoy
country: Turkey
facility: T.C. Saglik Bakanligi Goztepe Prof. Dr Suleyman Yalcin Sehir Hastanesi
city: Sariyer
country: Turkey
facility: Acibadem Maslak Hastanesi
city: Yenimahalle
country: Turkey
facility: Gazi Universitesi Gazi Hastanesi
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham NHS Trust, Birmingham Heartlands Hospital
city: Colchester
country: United Kingdom
facility: East Suffolk and North Essex NHS Foundation Trust
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre
city: Leeds
country: United Kingdom
facility: St James University Hospital
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: