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Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) (EVOKE-01)

Primary Purpose

Non-Small Cell Lung Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sacituzumab Govitecan-hziy (SG)
Docetaxel
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alaska Oncology and Hematology, LLC.
  • USOR - Arizona Oncology Associates Tucson - Wilmot
  • Beverly Hills Cancer Center
  • Rocky Mountain Cancer Centers - Aurora
  • Florida Cancer Specialists (Administration and Drug Shipment)
  • Woodlands Medical Specialists, PA
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • University of Chicago Medical Center
  • Illinois Cancer Specialists
  • Siouxland Regional Cancer Center dba June E. Nylen Cancer Center
  • Kansas City VA Medical Center
  • Baptist Health Lexington
  • Maryland Oncology Hematology, P.A.
  • Lahey Hospital & Medical Center
  • Park Nicollet Frauenshuh Cancer Center
  • Nebraska Hematology - Oncology
  • Comprehensive Cancer Centers of Nevada
  • Broome Oncology, LLC
  • Stony Brook Cancer Center
  • Levine Cancer Institute
  • FirstHealth Outpatient Cancer Center
  • W.G (Bill) Hefner VAMC
  • Zangmeister Cancer Center
  • Tennessee Oncology, PLLC
  • Baptist Clinical Research Institute
  • Texas Oncology - Bedford
  • Texas Oncology - Denison
  • Texas Oncology - Denton South
  • Texas Oncology Cancer Care and Research Center
  • USOR - Texas Oncology - McKinney
  • Texas Oncology - Paris
  • Texas Oncology-Plano East
  • Texas Oncology-Plano West
  • Shenandoah Oncology Associates, PC
  • University of Wisconsin Clinical Science Center
  • Froedtert Hospital/Medical College of Wisconsin
  • Border Medical Oncology Research Unit
  • Southern Highlands Cancer Centre
  • St Vincent's Public Hospital
  • Sunshine Coast University Private Hospital
  • Gallipoli Medical Research Foundation
  • Flinders Medical centre
  • Icon Cancer Centre
  • Box Hill Hospital
  • Monash Health
  • Peninsula & South Eastern Haematology and Oncology Group
  • Joondalup Health Campus
  • ir Charles Gairdner Hospital
  • Medizinische Universität Innsbruck, Medizinische Universitat Innsbruck, Universitatsklinik fur Innere Medizin V, Hamatologie und Onkolgie
  • Muellner Hauptstrabe 48
  • zuniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU
  • Klinik Floridsdorf, Karl Landsteiner Institute fur Lungenforschung und Pneumologische onkologie (LFPO) Abteilung Fur Innere Medizin un Pneumologie
  • Algemeen Ziekenhuis Klina
  • Cliniques Universitaires Saint-Luc
  • Universitair Ziekenhuis Antwerpen
  • Algemeen Ziekenhuis Sint-Lucas
  • Az Maria Middelares Ghent
  • CHU Ambroise Pare
  • CRIO - Centro Regional Integrado de Oncologia
  • ONCOSITE - Centro de Pesquisa Clinica em Oncologia
  • Catatina Pesquisa Clinica - Clinica de Neoplasias Litoral
  • Centro de Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho
  • Hospital de Clínicas de Porto Alegre - HCPA
  • Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa
  • Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP
  • Nucleo de Pesquisa da Rede Sao Camilo-Instituto Brasileiro de controle do cancer-IBC
  • A Beneficência Portuguesa de São Paulo
  • Royal Victoria Regional Health Centre
  • William Osler Health System-Brampton Civic Hospital
  • McGill University Health Centre
  • Required Centre Hospitalier Regional de Rimouski
  • Windsor Regional Hospital Cancer Program
  • Institut Sainte Catherine
  • Centre Hospitalier de la Côte Basque
  • APHP-Hopital Ambroise-Pare
  • CHU de CAEN
  • Centre Francois Baclesse
  • Centre Hospitalier de Chauny
  • CHU-Hopital Gabriel Montpied
  • Centre Hospitalier Intercommunal de Creteil
  • Centre Hospitalier Annecy Genevois
  • Centre Hospitalier Departemental Vendee
  • Clinique Victor Hugo
  • CHU de Lille
  • Hopital Dupuytren (CHU de Limoges)
  • Chu Montpellier Hopital Arnaud de Villeneuve
  • GHR Sud Alsace - Hopital Emile Muller
  • Institut Curie
  • CHU de Bordeaux Hopital Haut leveque
  • Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud
  • CHU de Poitiers
  • Centre Hospitalier Universitaire de Rouen - Hopitel Charles Nicolle
  • Institut de Cancérologie de l'Ouest - Paysde Loire (site SAINT HERBLAIN)
  • Hopital Foch
  • Institut Cancérologie Strasbourg Europe
  • CHITS-Hopital Sainte Musse
  • Stadtisches Klinikum Braunschweig gGmbH Medizinische Klinik III Hamatologie und Onkologie
  • Klinikum Esslingen GmbH Klinik fur Kardiologie,Angiologie und Pneumologie
  • Asklepios Klinikum Harburg, Thoraxzentrum Hamburg - Lungenabteilung
  • Studiengeselischaft Hamato-Onkologie Hamburg
  • Onkologische Schwerpunktpraxis Heilbronn
  • Lungenfachklink Immenhausen
  • Klinikum Kassel Klinik Für Hämatologie Onkologie Und Immunologie
  • Universitatsklinikum Schleswig-Holstein - Campus Lubeck, Medizinische Klinik III (Studienzentrum Pneumologie)
  • University Hospital Mannheim, Department of Personalized Medical Oncology with Section Thoracic Oncology
  • Asklepios-Fachkliniken Munchen-Gauting, Zentrum fur Pneumologie und Thoraxchirurgie
  • Sana Klinikum Offenbach, Medizinische Klinik IV fur Hamatologie und internistische Onkologie
  • Henry Dunant Hospital Center, 4th Oncology Department
  • General Hospital of Chest Diseases "I Sotiria", 3rd Internal Medicine Department of Athens University - Oncology Unit
  • Metropolitan General, Oncology department
  • General Oncology Hospital of Kifisia "Agioi Anargyroi", 2nd Department of Medical Oncology
  • University General Hospital of Larissa, Oncology Department-1St Internal Medical Division
  • General Oncology Hospital of Kifisia "Agioi Anargyroi", 2nd Department of Medical Oncology
  • Euromedica General Clinic of Thessaloniki
  • Interbalkan Medical Center of Thessaloniki
  • Samson Assuta Ashdod University Hospital
  • Soroka Medical Center
  • Hadassah University Hospital Ein Kerem
  • Kaplan Medical Center
  • Tel Aviv Sourasky Medical Center
  • Shamir Medical Center (Assaf Harofeh)
  • ASST Papa Giovanni XXIII, Oncologia Medica
  • Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia
  • AOU Policlinico G Rodlico-Oncologia Medica
  • AOU mater Domini, UOC Oncologia Medica e Oncologia Medica Trazionale
  • ASST Cremona
  • Instituto Europeo di Oncologia
  • ASST Grande Ospedale Metropolitano Niguarda SC Oncologia
  • Fondazione IRCCS Policlinico San Matteo
  • Fondazione Policlinico Universitario Campus Bio-Medico, UOC Oncologia Medica
  • UOC Oncologia
  • ASST Bergamo Ovest- ospedale di Treviglio-u.o. Oncologia
  • SC Oncologia -ASST SETTE LAGHI
  • National Hospital Organization Asahikawa Medical Center
  • National Cancer Center Hospital
  • Fukui Prefectural Hospital
  • Kansai Medical University Hospital
  • Hiroshima University Hospital
  • Kobe City Medical Center General Hospital
  • National Hospital Organization Himeji Medical Center
  • Nippon Medical School Chiba Hokusoh Hospital
  • National Hospital Organization Iwakuni Clinical Center
  • Kagoshima University Hospital
  • Kanagawa Prefectural Hospital Organization Kanagawa Cardiovascular and Respiratory Center
  • Kanazawa University Hospital
  • National Cancer Center Hospital East
  • Saitama Cancer Center
  • The Cancer Institute Hospital of JFCR
  • Kurume University Hospital
  • University Hospital Kyoto Prefectural University of Medicine
  • Shikoku Cancer Center
  • Miyagi Cancer Center
  • Nagasaki University Hospital
  • National Hospital Organization Nagoya Medical Center
  • Niigata Cancer Center Hospital
  • Okayama University Hospital
  • Kindai University Hospital
  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute
  • National Hospital Organization Kinki-Chuo Chest Medical Center
  • Centor Hospital of the National Center for Global Health and Medicine
  • Shizuoka Cancer Center
  • National Hospital Organization Osaka Toneyama Medical Center
  • Tochigi Cancer Center
  • Japanese Red Cross Wakayama Medical Center
  • Yokohama Municipal Citizen's Hospital
  • Kanagawa Cancer Center
  • Tottori University Hospital
  • Cryptex Investigación Clínica, S.A. de C.V.
  • Panamerican Clinical Research S.A. de C.V
  • Actualidad Basada en la Investigación del Cáncer
  • Amphia Hospital
  • Haaglanden Medical Centre
  • Maastricht Universitair Medisch Centrum
  • Erasmus MC
  • Elisabeth-TweeSteden Ziekenhuis (ETZ)
  • Przychodnia Lekarska Komed Roman Karaszewski
  • Instytut MSF Sp. z o.o.
  • Centrum Medyczne Mrukmed
  • Marzowiecki Szpital Wojewodzki sw Jana Pawla II Wsiedicach sp. z.o.o Siedickie centrum onkoiogii
  • Instituto Português de Oncologia de Coimbra Francisco Gentil
  • Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido Valente
  • Fundacao Champalimaud
  • Senhora da Hora
  • Hospital CUF Porto
  • Centro Hospitalar Universitario do Porto
  • Instituto Portugues de Oncologia do Porto
  • Ad-Vance Medical Research, LLC
  • Pan American Center For Oncology Trials, LLC
  • Complejo Hospitalario Universitario A Coruna. Hospital Teresa Herrera
  • Institut Catala d'Oncologia Badalona, ICO Badalona, Hospital Germans Trias i Pujol
  • Hospital Universitario Cruces
  • Hospital Universitari Dexeus
  • Hospital Universitario Vall D'Hebron
  • Institut Catala D'Oncologia (ICO L'Hospitalet) Hospital Duran i Reynals
  • Hospital San Pedro de Alcantara
  • Institut Catala d'Oncologia de Girona
  • Hospital Universitario de la Princesa
  • Hospital Universitario Gregorio Marañón
  • Hospital Universitario Fundacion Jimenez Dias
  • Hospital Universitario Ramón y Cajal
  • Hospital Clinical San Carlos
  • Hospital Universitario 12 Octubre
  • Hospital universitario la paz
  • Hospital Regional Universitario de Malaga-Hospital Civil
  • Hospital Clinicl universitario virgen de la Arrixaca
  • Clinica Universidad de Navarra-Pamplona
  • Hospital de Sabadell
  • Hospital Virgen de Valme
  • Hospital universitario Virgen Macarena
  • Hospital Universitario la Fe
  • Hacettepe Üniversitesi Hastanesi
  • Memorial Ankara Hastane
  • Acibadem Bursa Hastanesi
  • Ankara Sehir Hastanesi
  • Trakya Üniversitesi Sağlık Araştırma ve Uygulama Merkezi
  • Bagcilar Medipol Mega Universite Hastanesi
  • T.C. Saglik Bakanligi Goztepe Prof. Dr Suleyman Yalcin Sehir Hastanesi
  • Acibadem Maslak Hastanesi
  • Gazi Universitesi Gazi Hastanesi
  • University Hospital Birmingham NHS Trust, Birmingham Heartlands Hospital
  • East Suffolk and North Essex NHS Foundation Trust
  • The Beatson West of Scotland Cancer Centre
  • St James University Hospital
  • Leicester Royal Infirmary
  • Barts Health NHS Trust
  • The Christie NHS Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sacituzumab Govitecan-hziy (SG)

Docetaxel

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Overall Survival (OS)
OS is defined as the time from the date of randomization until the date of death from any cause.

Secondary Outcome Measures

Progression-free Survival (PFS) Assessed by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
PFS is defined as the time from the date of randomization until the date of objective disease progression (PD) or death from any cause, whichever occurs first.
Objective Response Rate (ORR) Assessed by Investigator per RECIST Version 1.1
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later.
Duration of Response (DOR) Assessed by Investigator per RECIST Version 1.1
DOR is defined as time from first documented CR or PR to the earlier of the first documented PD or death from any cause (whichever comes first)
Disease Control Rate (DCR) Assessed by Investigator per RECIST Version 1.1
DCR is defined as the proportion of participants who achieve a CR, PR, or stable disease (SD) as assessed by RECIST Version 1.1.
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Percentage of Participants Experiencing Laboratory abnormalities
Time to First Deterioration in Shortness of Breath Domain as Measured by Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) Score
The NSCLC-SAQ is a patient reported outcome measure with seven items assessing five symptom concepts of NSCLC: cough, pain, dyspnea, fatigue, and appetite. Each item is rated using a five-point verbal rating scale from "No <symptom> At All" to "Very severe <symptom>" or from "Never to Always," corresponding to a score of 0 to 4. The dyspnea (shortness of breath) item uses a "Never to Always" rating scale with higher score indicating higher frequency of dyspnea.
Time to First Deterioration in NSCLC-SAQ Total Score
The NSCLC-SAQ is a patient reported outcome measure with seven items assessing five symptom concepts of NSCLC: cough, pain, dyspnea, fatigue, and appetite. Each item is rated using a five-point verbal rating scale from "No <symptom> At All" to "Very severe <symptom>" or from "Never to Always," corresponding to a score of 0 to 4. The sum of all 5 domain scores will be computed, if any scores are missing, a total score will not be computed. The total score ranges between 0 and 20 with higher scores indicating more severe symptoms.

Full Information

First Posted
October 11, 2021
Last Updated
June 28, 2023
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05089734
Brief Title
Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Acronym
EVOKE-01
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 17, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
580 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sacituzumab Govitecan-hziy (SG)
Arm Type
Experimental
Arm Description
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.
Arm Title
Docetaxel
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Sacituzumab Govitecan-hziy (SG)
Other Intervention Name(s)
IMMU-132, GS-0132
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Administered intravenously
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from the date of randomization until the date of death from any cause.
Time Frame
Up to 30 months
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS) Assessed by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Description
PFS is defined as the time from the date of randomization until the date of objective disease progression (PD) or death from any cause, whichever occurs first.
Time Frame
Up to 30 months
Title
Objective Response Rate (ORR) Assessed by Investigator per RECIST Version 1.1
Description
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later.
Time Frame
Up to 30 months
Title
Duration of Response (DOR) Assessed by Investigator per RECIST Version 1.1
Description
DOR is defined as time from first documented CR or PR to the earlier of the first documented PD or death from any cause (whichever comes first)
Time Frame
Up to 30 months
Title
Disease Control Rate (DCR) Assessed by Investigator per RECIST Version 1.1
Description
DCR is defined as the proportion of participants who achieve a CR, PR, or stable disease (SD) as assessed by RECIST Version 1.1.
Time Frame
Up to 30 months
Title
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time Frame
First dose date up to 30 months plus 30 days
Title
Percentage of Participants Experiencing Laboratory abnormalities
Time Frame
First dose date up to 30 months plus 30 days
Title
Time to First Deterioration in Shortness of Breath Domain as Measured by Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) Score
Description
The NSCLC-SAQ is a patient reported outcome measure with seven items assessing five symptom concepts of NSCLC: cough, pain, dyspnea, fatigue, and appetite. Each item is rated using a five-point verbal rating scale from "No <symptom> At All" to "Very severe <symptom>" or from "Never to Always," corresponding to a score of 0 to 4. The dyspnea (shortness of breath) item uses a "Never to Always" rating scale with higher score indicating higher frequency of dyspnea.
Time Frame
Up to 30 Months
Title
Time to First Deterioration in NSCLC-SAQ Total Score
Description
The NSCLC-SAQ is a patient reported outcome measure with seven items assessing five symptom concepts of NSCLC: cough, pain, dyspnea, fatigue, and appetite. Each item is rated using a five-point verbal rating scale from "No <symptom> At All" to "Very severe <symptom>" or from "Never to Always," corresponding to a score of 0 to 4. The sum of all 5 domain scores will be computed, if any scores are missing, a total score will not be computed. The total score ranges between 0 and 20 with higher scores indicating more severe symptoms.
Time Frame
Up to 30 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Alaska Oncology and Hematology, LLC.
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
USOR - Arizona Oncology Associates Tucson - Wilmot
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
Beverly Hills Cancer Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Florida Cancer Specialists (Administration and Drug Shipment)
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Woodlands Medical Specialists, PA
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Florida Cancer Specialists
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Florida Cancer Specialists
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Illinois Cancer Specialists
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Siouxland Regional Cancer Center dba June E. Nylen Cancer Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Kansas City VA Medical Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Maryland Oncology Hematology, P.A.
City
Clinton
State/Province
Maryland
ZIP/Postal Code
20735
Country
United States
Facility Name
Lahey Hospital & Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Park Nicollet Frauenshuh Cancer Center
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Nebraska Hematology - Oncology
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Broome Oncology, LLC
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
Stony Brook Cancer Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
FirstHealth Outpatient Cancer Center
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
W.G (Bill) Hefner VAMC
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Zangmeister Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Baptist Clinical Research Institute
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Texas Oncology - Bedford
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Texas Oncology - Denison
City
Denison
State/Province
Texas
ZIP/Postal Code
75020
Country
United States
Facility Name
Texas Oncology - Denton South
City
Denton
State/Province
Texas
ZIP/Postal Code
76201
Country
United States
Facility Name
Texas Oncology Cancer Care and Research Center
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
USOR - Texas Oncology - McKinney
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Facility Name
Texas Oncology - Paris
City
Paris
State/Province
Texas
ZIP/Postal Code
75460
Country
United States
Facility Name
Texas Oncology-Plano East
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Texas Oncology-Plano West
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Shenandoah Oncology Associates, PC
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
University of Wisconsin Clinical Science Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Froedtert Hospital/Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Border Medical Oncology Research Unit
City
Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
Facility Name
Southern Highlands Cancer Centre
City
Bowral
State/Province
New South Wales
ZIP/Postal Code
2576
Country
Australia
Facility Name
St Vincent's Public Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Sunshine Coast University Private Hospital
City
Birtinya
State/Province
Queensland
ZIP/Postal Code
4575
Country
Australia
Facility Name
Gallipoli Medical Research Foundation
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Flinders Medical centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Icon Cancer Centre
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Monash Health
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Peninsula & South Eastern Haematology and Oncology Group
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Joondalup Health Campus
City
Joondalup
State/Province
Western Australia
ZIP/Postal Code
6027
Country
Australia
Facility Name
ir Charles Gairdner Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Medizinische Universität Innsbruck, Medizinische Universitat Innsbruck, Universitatsklinik fur Innere Medizin V, Hamatologie und Onkolgie
City
Innsbruck
ZIP/Postal Code
06020
Country
Austria
Facility Name
Muellner Hauptstrabe 48
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
zuniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU
City
Salzburg
ZIP/Postal Code
A-5020
Country
Austria
Facility Name
Klinik Floridsdorf, Karl Landsteiner Institute fur Lungenforschung und Pneumologische onkologie (LFPO) Abteilung Fur Innere Medizin un Pneumologie
City
Vienna
ZIP/Postal Code
1210
Country
Austria
Facility Name
Algemeen Ziekenhuis Klina
City
Brasschaat
ZIP/Postal Code
2930
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Algemeen Ziekenhuis Sint-Lucas
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Az Maria Middelares Ghent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
CHU Ambroise Pare
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
CRIO - Centro Regional Integrado de Oncologia
City
Fortaleza
ZIP/Postal Code
60810180
Country
Brazil
Facility Name
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
City
Ijui
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Catatina Pesquisa Clinica - Clinica de Neoplasias Litoral
City
Itajai
ZIP/Postal Code
88331-10
Country
Brazil
Facility Name
Centro de Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho
City
Jau
ZIP/Postal Code
17210080
Country
Brazil
Facility Name
Hospital de Clínicas de Porto Alegre - HCPA
City
Porto Alegre
ZIP/Postal Code
90035903
Country
Brazil
Facility Name
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa
City
Porto Alegre
ZIP/Postal Code
90110-270
Country
Brazil
Facility Name
Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP
City
Sao Paolo
Country
Brazil
Facility Name
Nucleo de Pesquisa da Rede Sao Camilo-Instituto Brasileiro de controle do cancer-IBC
City
Sao Paulo
ZIP/Postal Code
03102002
Country
Brazil
Facility Name
A Beneficência Portuguesa de São Paulo
City
São Paulo
Country
Brazil
Facility Name
Royal Victoria Regional Health Centre
City
Barrie
ZIP/Postal Code
L4M 6M2
Country
Canada
Facility Name
William Osler Health System-Brampton Civic Hospital
City
Brampton
ZIP/Postal Code
L6R 3J7
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Required Centre Hospitalier Regional de Rimouski
City
Rimouski
ZIP/Postal Code
G5L5T1
Country
Canada
Facility Name
Windsor Regional Hospital Cancer Program
City
Windsor
ZIP/Postal Code
N8W 2X3
Country
Canada
Facility Name
Institut Sainte Catherine
City
Avignon
ZIP/Postal Code
84918
Country
France
Facility Name
Centre Hospitalier de la Côte Basque
City
Bayonne
ZIP/Postal Code
64100
Country
France
Facility Name
APHP-Hopital Ambroise-Pare
City
Boulogne-Billancourt
ZIP/Postal Code
92100
Country
France
Facility Name
CHU de CAEN
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Centre Francois Baclesse
City
Calvados
ZIP/Postal Code
14076 CEDEX 05
Country
France
Facility Name
Centre Hospitalier de Chauny
City
Chauny
ZIP/Postal Code
02300
Country
France
Facility Name
CHU-Hopital Gabriel Montpied
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Centre Hospitalier Intercommunal de Creteil
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Hospitalier Annecy Genevois
City
Epagny Metz-tessy
ZIP/Postal Code
74374
Country
France
Facility Name
Centre Hospitalier Departemental Vendee
City
La Roche-sur-Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Clinique Victor Hugo
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
CHU de Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Hopital Dupuytren (CHU de Limoges)
City
Limoges cedex
ZIP/Postal Code
87042
Country
France
Facility Name
Chu Montpellier Hopital Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295 CEDEX
Country
France
Facility Name
GHR Sud Alsace - Hopital Emile Muller
City
Mulhouse
ZIP/Postal Code
68100
Country
France
Facility Name
Institut Curie
City
Paris cedex 05
Country
France
Facility Name
CHU de Bordeaux Hopital Haut leveque
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Centre Hospitalier Universitaire de Rouen - Hopitel Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Institut de Cancérologie de l'Ouest - Paysde Loire (site SAINT HERBLAIN)
City
saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Hopital Foch
City
Saint Herblain
Country
France
Facility Name
Institut Cancérologie Strasbourg Europe
City
Strasbourg
ZIP/Postal Code
67033
Country
France
Facility Name
CHITS-Hopital Sainte Musse
City
Toulon cedex
ZIP/Postal Code
83056
Country
France
Facility Name
Stadtisches Klinikum Braunschweig gGmbH Medizinische Klinik III Hamatologie und Onkologie
City
Braunschweig
ZIP/Postal Code
38114
Country
Germany
Facility Name
Klinikum Esslingen GmbH Klinik fur Kardiologie,Angiologie und Pneumologie
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
Facility Name
Asklepios Klinikum Harburg, Thoraxzentrum Hamburg - Lungenabteilung
City
Hamburg
ZIP/Postal Code
21075
Country
Germany
Facility Name
Studiengeselischaft Hamato-Onkologie Hamburg
City
Hamburg
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis Heilbronn
City
Heilbronn
ZIP/Postal Code
74245
Country
Germany
Facility Name
Lungenfachklink Immenhausen
City
Immenhausen
ZIP/Postal Code
34376
Country
Germany
Facility Name
Klinikum Kassel Klinik Für Hämatologie Onkologie Und Immunologie
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Facility Name
Universitatsklinikum Schleswig-Holstein - Campus Lubeck, Medizinische Klinik III (Studienzentrum Pneumologie)
City
Lubeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
University Hospital Mannheim, Department of Personalized Medical Oncology with Section Thoracic Oncology
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Asklepios-Fachkliniken Munchen-Gauting, Zentrum fur Pneumologie und Thoraxchirurgie
City
Munchen-Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Sana Klinikum Offenbach, Medizinische Klinik IV fur Hamatologie und internistische Onkologie
City
Offenbach
ZIP/Postal Code
63069
Country
Germany
Facility Name
Henry Dunant Hospital Center, 4th Oncology Department
City
Athens
ZIP/Postal Code
11526
Country
Greece
Facility Name
General Hospital of Chest Diseases "I Sotiria", 3rd Internal Medicine Department of Athens University - Oncology Unit
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Metropolitan General, Oncology department
City
Cholargos
ZIP/Postal Code
15562
Country
Greece
Facility Name
General Oncology Hospital of Kifisia "Agioi Anargyroi", 2nd Department of Medical Oncology
City
Heraklion
Country
Greece
Facility Name
University General Hospital of Larissa, Oncology Department-1St Internal Medical Division
City
Larisa
ZIP/Postal Code
413 34
Country
Greece
Facility Name
General Oncology Hospital of Kifisia "Agioi Anargyroi", 2nd Department of Medical Oncology
City
Nea Kifisia
ZIP/Postal Code
14565
Country
Greece
Facility Name
Euromedica General Clinic of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
54645
Country
Greece
Facility Name
Interbalkan Medical Center of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
555 35
Country
Greece
Facility Name
Samson Assuta Ashdod University Hospital
City
Ashdod
ZIP/Postal Code
7747629
Country
Israel
Facility Name
Soroka Medical Center
City
Beer Seva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Hadassah University Hospital Ein Kerem
City
Jerusalem
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Facility Name
Shamir Medical Center (Assaf Harofeh)
City
Tzrifin
Country
Israel
Facility Name
ASST Papa Giovanni XXIII, Oncologia Medica
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
AOU Policlinico G Rodlico-Oncologia Medica
City
Catania
ZIP/Postal Code
95125
Country
Italy
Facility Name
AOU mater Domini, UOC Oncologia Medica e Oncologia Medica Trazionale
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
ASST Cremona
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
Instituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda SC Oncologia
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Fondazione Policlinico Universitario Campus Bio-Medico, UOC Oncologia Medica
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
UOC Oncologia
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
ASST Bergamo Ovest- ospedale di Treviglio-u.o. Oncologia
City
Treviglio
ZIP/Postal Code
24047
Country
Italy
Facility Name
SC Oncologia -ASST SETTE LAGHI
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
National Hospital Organization Asahikawa Medical Center
City
Asahikawa
ZIP/Postal Code
070-8644
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Fukui Prefectural Hospital
City
Fukui
ZIP/Postal Code
910-8526
Country
Japan
Facility Name
Kansai Medical University Hospital
City
Hirakata
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
National Hospital Organization Himeji Medical Center
City
Hyogo
ZIP/Postal Code
670-8520
Country
Japan
Facility Name
Nippon Medical School Chiba Hokusoh Hospital
City
Inzai
ZIP/Postal Code
270-1694
Country
Japan
Facility Name
National Hospital Organization Iwakuni Clinical Center
City
Iwakuni
ZIP/Postal Code
740-8510
Country
Japan
Facility Name
Kagoshima University Hospital
City
Kagoshima
ZIP/Postal Code
8908520
Country
Japan
Facility Name
Kanagawa Prefectural Hospital Organization Kanagawa Cardiovascular and Respiratory Center
City
Kanagawaken
ZIP/Postal Code
236-0051
Country
Japan
Facility Name
Kanazawa University Hospital
City
Kanazawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Saitama Cancer Center
City
Kitaadachi-gun
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR
City
Koto
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
University Hospital Kyoto Prefectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Shikoku Cancer Center
City
Matsuyama
ZIP/Postal Code
791-0280
Country
Japan
Facility Name
Miyagi Cancer Center
City
Miyagi
ZIP/Postal Code
981-1293
Country
Japan
Facility Name
Nagasaki University Hospital
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
National Hospital Organization Nagoya Medical Center
City
Nagoya
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Kindai University Hospital
City
Osakasayama-Shi
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Facility Name
National Hospital Organization Kinki-Chuo Chest Medical Center
City
Sakai
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Centor Hospital of the National Center for Global Health and Medicine
City
Shinjuku-Ku
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Sunto-gun
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
National Hospital Organization Osaka Toneyama Medical Center
City
Toyonaka
ZIP/Postal Code
560-8552
Country
Japan
Facility Name
Tochigi Cancer Center
City
Utsunomiya
ZIP/Postal Code
320-0834
Country
Japan
Facility Name
Japanese Red Cross Wakayama Medical Center
City
Wakayama
ZIP/Postal Code
640-8558
Country
Japan
Facility Name
Yokohama Municipal Citizen's Hospital
City
Yokohama
ZIP/Postal Code
221-0855
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Yokohama
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Tottori University Hospital
City
Yonago
ZIP/Postal Code
683-8504
Country
Japan
Facility Name
Cryptex Investigación Clínica, S.A. de C.V.
City
Ciudad de Mexico
ZIP/Postal Code
06100
Country
Mexico
Facility Name
Panamerican Clinical Research S.A. de C.V
City
Guadalajara
ZIP/Postal Code
44670
Country
Mexico
Facility Name
Actualidad Basada en la Investigación del Cáncer
City
Guadalajara
Country
Mexico
Facility Name
Amphia Hospital
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
Haaglanden Medical Centre
City
Den Haag
ZIP/Postal Code
2262BA
Country
Netherlands
Facility Name
Maastricht Universitair Medisch Centrum
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterrdam
ZIP/Postal Code
3015
Country
Netherlands
Facility Name
Elisabeth-TweeSteden Ziekenhuis (ETZ)
City
Tilburg
ZIP/Postal Code
5022
Country
Netherlands
Facility Name
Przychodnia Lekarska Komed Roman Karaszewski
City
Konin
ZIP/Postal Code
62-500
Country
Poland
Facility Name
Instytut MSF Sp. z o.o.
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Centrum Medyczne Mrukmed
City
Rzeszáw
ZIP/Postal Code
35-085
Country
Poland
Facility Name
Marzowiecki Szpital Wojewodzki sw Jana Pawla II Wsiedicach sp. z.o.o Siedickie centrum onkoiogii
City
Siedlce
ZIP/Postal Code
08-110
Country
Poland
Facility Name
Instituto Português de Oncologia de Coimbra Francisco Gentil
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido Valente
City
Lisboa
ZIP/Postal Code
1769-001
Country
Portugal
Facility Name
Fundacao Champalimaud
City
Lisbon
Country
Portugal
Facility Name
Senhora da Hora
City
Matosinhos
ZIP/Postal Code
4464-513
Country
Portugal
Facility Name
Hospital CUF Porto
City
Porto
ZIP/Postal Code
14341
Country
Portugal
Facility Name
Centro Hospitalar Universitario do Porto
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Instituto Portugues de Oncologia do Porto
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Ad-Vance Medical Research, LLC
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
Facility Name
Pan American Center For Oncology Trials, LLC
City
San Juan
ZIP/Postal Code
00902
Country
Puerto Rico
Facility Name
Complejo Hospitalario Universitario A Coruna. Hospital Teresa Herrera
City
A coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Institut Catala d'Oncologia Badalona, ICO Badalona, Hospital Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario Cruces
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Universitari Dexeus
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Universitario Vall D'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Institut Catala D'Oncologia (ICO L'Hospitalet) Hospital Duran i Reynals
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital San Pedro de Alcantara
City
Cáceres
ZIP/Postal Code
10004
Country
Spain
Facility Name
Institut Catala d'Oncologia de Girona
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Universitario de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Dias
City
Madrid
ZIP/Postal Code
28020
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clinical San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital universitario la paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Regional Universitario de Malaga-Hospital Civil
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Clinicl universitario virgen de la Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Clinica Universidad de Navarra-Pamplona
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital de Sabadell
City
Sabadell
ZIP/Postal Code
8208
Country
Spain
Facility Name
Hospital Virgen de Valme
City
Sevilla
ZIP/Postal Code
41001
Country
Spain
Facility Name
Hospital universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario la Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hacettepe Üniversitesi Hastanesi
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Memorial Ankara Hastane
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Facility Name
Acibadem Bursa Hastanesi
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Facility Name
Ankara Sehir Hastanesi
City
Dikimevi- Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Trakya Üniversitesi Sağlık Araştırma ve Uygulama Merkezi
City
Edirne
Country
Turkey
Facility Name
Bagcilar Medipol Mega Universite Hastanesi
City
Istanbul
Country
Turkey
Facility Name
T.C. Saglik Bakanligi Goztepe Prof. Dr Suleyman Yalcin Sehir Hastanesi
City
Kadikoy
Country
Turkey
Facility Name
Acibadem Maslak Hastanesi
City
Sariyer
Country
Turkey
Facility Name
Gazi Universitesi Gazi Hastanesi
City
Yenimahalle
Country
Turkey
Facility Name
University Hospital Birmingham NHS Trust, Birmingham Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
East Suffolk and North Essex NHS Foundation Trust
City
Colchester
ZIP/Postal Code
CO4 5JL
Country
United Kingdom
Facility Name
The Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
St James University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Barts Health NHS Trust
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
The Christie NHS Foundation
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.gileadclinicaltrials.com/study/?id=GS-US-577-6153
Description
Gilead Clinical Trials Website

Learn more about this trial

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

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