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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2051220119 | Registry Identifier | Japan Registry of Clinical Trials | |
| 2024-512148-50 | Other Identifier | European Medicines Agency |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacituzumab Govitecan-hziy (SG) | Experimental | Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle (ie, 2 weekly doses plus 1 week without treatment) until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met. |
|
| Docetaxel | Active Comparator | Participants will receive docetaxel 75 mg/m^2 on Day 1 of a 21-day cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion is met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacituzumab Govitecan-hziy (SG) | Biological | Administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from the date of randomization until the date of death from any cause. OS was estimated using Kaplan-Meier estimate. Participants without documentation of death were censored on the date they were last known to be alive. | Up to 24.4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 as assessed by RECIST v.1.1. As per RECIST 1.1, PD was defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study), in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or the appearance of of 1 or more new lesions or unequivocal progression of existing non-target lesions. Participants who did not have documented disease progression and did not die were censored at their last tumor assessment date. Kaplan-Meier estimate was used for analysis. |
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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.
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alaska Oncology and Hematology, LLC. | Anchorage | Alaska | 99508 | United States | ||
| USOR - Arizona Oncology Associates Tucson - Wilmot |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38843511 | Derived | Paz-Ares LG, Juan-Vidal O, Mountzios GS, Felip E, Reinmuth N, de Marinis F, Girard N, Patel VM, Takahama T, Owen SP, Reznick DM, Badin FB, Cicin I, Mekan S, Patel R, Zhang E, Karumanchi D, Garassino MC. Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study. J Clin Oncol. 2024 Aug 20;42(24):2860-2872. doi: 10.1200/JCO.24.00733. Epub 2024 May 31. |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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784 participants were screened. Data submitted represent interim analysis performed on data collected by the Primary Completion Date. Complete data will be submitted in May 2026.
Participants were enrolled at study sites in Europe, North America, Brazil, Israel, Japan, Turkey, Australia, and Puerto Rico.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sacituzumab Govitecan (SG) | Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow intravenous (IV) infusion on Days 1 and 8 of a 21-day treatment cycle until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 18.7 months). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 22, 2022 | Oct 31, 2024 |
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| Docetaxel | Drug | Administered intravenously |
|
| Up to 24.4 months |
| Objective Response Rate (ORR) Assessed by Investigator Per RECIST Version 1.1 | ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) that was confirmed at least 4 weeks later as assessed by RECIST v.1.1. As per RECIST 1.1 CR was defined as: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR was defined as: At least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. | Up to 24.4 months |
| Duration of Response (DOR) Assessed by Investigator Per RECIST Version 1.1 | DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of PD or death from any cause (whichever comes first) as assessed by RECIST v. 1.1. As per RECIST 1.1 CR was disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR was at least 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD, and PD was at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study), in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or the appearance of of 1 or more new lesions or unequivocal progression of existing non-target lesions. Kaplan-Meier estimate was used for analysis. | Up to 24.4 months |
| Disease Control Rate (DCR) Assessed by Investigator Per RECIST Version 1.1 | DCR was defined as the percentage of participants who achieved a CR, PR,or stable disease(SD)as assessed by RECIST v.1.1. Per RECIST 1.1 CR was disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal;PR was at least 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference the smallest sum LD since the treatment started and persistence of 1 or more nontarget lesion(s).PD was at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study),in addition of increase of 20% sum also demonstrate an absolute increase of at least 5 mm or appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions. | Up to 24.4 months |
| Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) | An AE was defined as any untoward medical occurrence in a participants administered a medicinal product that does not necessarily have a causal relationship with this treatment. TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of the study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0. | Up to 3.5 years |
| Percentage of Participants Who Experienced Grade 3 or 4 Treatment Emergent Laboratory Abnormalities Post-Baseline | Blood samples were collected for hematology, serum chemistry, and the laboratory abnormalities were assessed. A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last study drug dose plus 30 days.The most severe graded abnormality observed post-baseline for each graded test was counted for each participant. Safety as assessed by grading of laboratory values and AEs according to the National Cancer Institutes' Common Terminology Criteria for Adverse Events (NCI CTCAE) covering grades 0-5 (0=Normal, 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death). The percentage of participants with worst postbaseline grades 3 or 4 will be reported. | Up to 3.5 years |
| Time to First Deterioration in Shortness of Breath Domain as Measured by Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) | The NSCLC-SAQ is a participant reported outcome 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" depending on the item's question structure relative to either intensity or frequency, corresponding to a score of 0 to 4, with total score ranging from 0 to 20. The dyspnea (shortness of breath) item uses a "Never(0) to Always(4)" rating scale with higher score indicating higher frequency of dyspnea. Time to deterioration (TTD) was defined as the time from date of randomization to the first date a participant achieves 2-point deterioration from baseline. For shortness of breath domain, a 1-point or greater worsening from baseline represents a clinically meaningful deterioration. Kaplan-Meier estimate was used for analysis. | Up to 24.4 months |
| Time to First Deterioration in NSCLC-SAQ Total Score | The NSCLC-SAQ is a participant 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" depending on the item's question structure relative to either intensity or frequency, corresponding to a score of 0 to 4. A total score sums all five domain scores at each visit. If any domain score was missing, the score was not computed. The total score ranges between 0 and 20, with higher scores indicating more severe symptoms. TTD was defined as the time from date of randomization to the first date a participant achieves 2-point deterioration from baseline. For NSCLC-SAQ total score, a 2-point or greater worsening from baseline represents a clinically meaningful deterioration. Kaplan-Meier estimate was used for analysis. | Up to 24.4 months |
| 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 | St. 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 |
| Sunshine Coast University Private Hospital | Birtinya | Queensland | 4575 | 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 |
| Joondalup Health Campus | Joondalup | Western Australia | 6027 | Australia |
| ir Charles Gairdner Hospital | Perth | Western Australia | 6009 | Australia |
| Medizinische Universität Innsbruck, Medizinische Universitat Innsbruck, Universitatsklinik fur Innere Medizin V, Hamatologie und Onkolgie | Innsbruck | 06020 | Austria |
| Muellner Hauptstrabe 48 | Salzburg | 5020 | Austria |
| zuniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU | Salzburg | A-5020 | 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 |
| Algemeen Ziekenhuis Sint-Lucas | Ghent | 9000 | Belgium |
| Az Maria Middelares Ghent | Ghent | 9000 | Belgium |
| CHU Ambroise Pare | Mons | 7000 | Belgium |
| CRIO - Centro Regional Integrado de Oncologia | Fortaleza | 60810180 | Brazil |
| ONCOSITE - Centro de Pesquisa Clinica em Oncologia | Ijuí | 98700-000 | Brazil |
| Catatina Pesquisa Clinica - Clinica de Neoplasias Litoral | Itajaí | 88331-10 | Brazil |
| Centro de Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho | Jaú | 17210080 | Brazil |
| Hospital de Clínicas de Porto Alegre - HCPA | Porto Alegre | 90035903 | Brazil |
| Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa | Porto Alegre | 90110-270 | Brazil |
| Nucleo de Pesquisa da Rede Sao Camilo-Instituto Brasileiro de controle do cancer-IBC | São Paulo | 03102002 | Brazil |
| A Beneficência Portuguesa de São Paulo | São Paulo | Brazil |
| Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP | São Paulo | Brazil |
| Royal Victoria Regional Health Centre | Barrie | L4M 6M2 | Canada |
| William Osler Health System-Brampton Civic Hospital | Brampton | L6R 3J7 | Canada |
| McGill University Health Centre | Montreal | H4A 3J1 | Canada |
| Required Centre Hospitalier Regional de Rimouski | Rimouski | G5L5T1 | Canada |
| Windsor Regional Hospital Cancer Program | Windsor | N8W 2X3 | 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 CEDEX 05 | France |
| Centre Hospitalier de Chauny | Chauny | 02300 | France |
| CHU-Hopital Gabriel Montpied | Clermont-Ferrand | 63000 | France |
| Centre Hospitalier Intercommunal de Creteil | Créteil | 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 |
| Hopital Dupuytren (CHU de Limoges) | Limoges | 87042 | France |
| Chu Montpellier Hopital Arnaud de Villeneuve | Montpellier | 34295 CEDEX | France |
| GHR Sud Alsace - Hopital Emile Muller | Mulhouse | 68100 | France |
| Institut Curie | Paris | France |
| CHU de Bordeaux Hopital Haut leveque | Pessac | 33600 | France |
| Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud | Pierre-Bénite | 69495 | France |
| CHU de Poitiers | Poitiers | 86021 | France |
| Centre Hospitalier Universitaire de Rouen - Hopitel Charles Nicolle | Rouen | 76031 | France |
| Institut de Cancérologie de l'Ouest - Paysde Loire (site SAINT HERBLAIN) | Saint-Herblain | 44805 | France |
| Hopital Foch | Saint-Herblain | France |
| Institut Cancérologie Strasbourg Europe | Strasbourg | 67033 | France |
| CHITS-Hopital Sainte Musse | Toulon | 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 am Neckar | 73730 | 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 |
| Universitatsklinikum Schleswig-Holstein - Campus Lubeck, Medizinische Klinik III (Studienzentrum Pneumologie) | Lübeck | 23538 | Germany |
| University Hospital Mannheim, Department of Personalized Medical Oncology with Section Thoracic Oncology | Mannheim | 68167 | Germany |
| Asklepios-Fachkliniken Munchen-Gauting, Zentrum fur Pneumologie und Thoraxchirurgie | Munchen-Gauting | 82131 | 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 | Cholargós | 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 | Larissa | 413 34 | 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 35 | Greece |
| Samson Assuta Ashdod University Hospital | Ashdod | 7747629 | Israel |
| Soroka Medical Center | Beersheba | 84101 | Israel |
| Hadassah University Hospital Ein Kerem | Jerusalem | Israel |
| Kaplan Medical Center | Rehovot | 76100 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | Israel |
| Shamir Medical Center (Assaf Harofeh) | Tzrifin | Israel |
| ASST Papa Giovanni XXIII, Oncologia Medica | Bergamo | 24127 | Italy |
| Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia | Brescia | 25123 | 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 | Milan | 20141 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda SC Oncologia | Milan | 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 | 24047 | Italy |
| SC Oncologia -ASST SETTE LAGHI | Varese | 21100 | Italy |
| National Hospital Organization Asahikawa Medical Center | Asahikawa | 070-8644 | Japan |
| National Cancer Center Hospital | Chūō | 104-0045 | Japan |
| Fukui Prefectural Hospital | Fukui | 910-8526 | Japan |
| Kansai Medical University Hospital | Hirakata | 573-1191 | Japan |
| Hiroshima University Hospital | Hiroshima | 734-8551 | Japan |
| Kobe City Medical Center General Hospital | Hyōgo | 650-0047 | Japan |
| National Hospital Organization Himeji Medical Center | Hyōgo | 670-8520 | Japan |
| Nippon Medical School Chiba Hokusoh Hospital | Inzai | 270-1694 | Japan |
| National Hospital Organization Iwakuni Clinical Center | Iwakuni | 740-8510 | Japan |
| Kagoshima University Hospital | Kagoshima | 8908520 | Japan |
| Kanagawa Prefectural Hospital Organization Kanagawa Cardiovascular and Respiratory Center | Kanagawaken | 236-0051 | Japan |
| Kanazawa University Hospital | Kanazawa | 920-8641 | Japan |
| National Cancer Center Hospital East | Kashiwa | 277-8577 | Japan |
| Saitama Cancer Center | Kitaadachi-gun | 362-0806 | Japan |
| The Cancer Institute Hospital of JFCR | Kōtō City | 135-8550 | Japan |
| Kurume University Hospital | Kurume | 830-0011 | Japan |
| University Hospital Kyoto Prefectural University of Medicine | Kyoto | 602-8566 | Japan |
| Shikoku Cancer Center | Matsuyama | 791-0280 | Japan |
| Miyagi Cancer Center | Miyagi | 981-1293 | Japan |
| Nagasaki University Hospital | Nagasaki | 852-8501 | Japan |
| National Hospital Organization Nagoya Medical Center | Nagoya | 460-0001 | Japan |
| Niigata Cancer Center Hospital | Niigata | 951-8566 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| Osaka Prefectural Hospital Organization Osaka International Cancer Institute | Osaka | 541-8567 | Japan |
| Kindai University Hospital | Osakasayama-Shi | 589-8511 | Japan |
| National Hospital Organization Kinki-Chuo Chest Medical Center | Sakai | 591-8555 | Japan |
| Centor Hospital of the National Center for Global Health and Medicine | Shinjuku-Ku | 162-8655 | Japan |
| Shizuoka Cancer Center | Sunto-gun | 411-8777 | Japan |
| National Hospital Organization Osaka Toneyama Medical Center | Toyonaka | 560-8552 | Japan |
| Tochigi Cancer Center | Utsunomiya | 320-0834 | Japan |
| Japanese Red Cross Wakayama Medical Center | Wakayama | 640-8558 | Japan |
| Yokohama Municipal Citizen's Hospital | Yokohama | 221-0855 | Japan |
| Kanagawa Cancer Center | Yokohama | 241-8515 | Japan |
| Tottori University Hospital | Yonago | 683-8504 | Japan |
| Panamerican Clinical Research S.A. de C.V | Guadalajara | 44670 | Mexico |
| Actualidad Basada en la Investigación del Cáncer | Guadalajara | Mexico |
| Cryptex Investigación Clínica, S.A. de C.V. | Mexico City | 06100 | Mexico |
| Amphia Hospital | Breda | 4818 CK | Netherlands |
| Maastricht Universitair Medisch Centrum | Maastricht | 6229 HX | Netherlands |
| Erasmus MC | Rotterrdam | 3015 | Netherlands |
| Haaglanden Medical Centre | The Hague | 2262BA | Netherlands |
| Elisabeth-TweeSteden Ziekenhuis (ETZ) | Tilburg | 5022 | Netherlands |
| Przychodnia Lekarska Komed Roman Karaszewski | Konin | 62-500 | Poland |
| Instytut MSF Sp. z o.o. | Lodz | 90-302 | Poland |
| Centrum Medyczne Mrukmed | Rzeszáw | 35-085 | Poland |
| Marzowiecki Szpital Wojewodzki sw Jana Pawla II Wsiedicach sp. z.o.o Siedickie centrum onkoiogii | Siedlce | 08-110 | Poland |
| Instituto Português de Oncologia de Coimbra Francisco Gentil | Coimbra | 3000-075 | Portugal |
| Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido Valente | Lisbon | 1769-001 | Portugal |
| Fundacao Champalimaud | Lisbon | Portugal |
| Senhora da Hora | Matosinhos Municipality | 4464-513 | Portugal |
| Hospital CUF Porto | Porto | 14341 | Portugal |
| Centro Hospitalar Universitario do Porto | Porto | 4099-001 | Portugal |
| Instituto Portugues de Oncologia do Porto | Porto | 4200-072 | Portugal |
| Pan American Center For Oncology Trials, LLC | San Juan | PR | 00902 | Puerto Rico |
| Ad-Vance Medical Research, LLC | Ponce | 00717 | Puerto Rico |
| Complejo Hospitalario Universitario A Coruna. Hospital Teresa Herrera | A Coruña | 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 | Málaga | 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 | Seville | 41001 | Spain |
| Hospital universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Universitario la Fe | Valencia | 46026 | Spain |
| Hacettepe Üniversitesi Hastanesi | Ankara | 06230 | Turkey (Türkiye) |
| Memorial Ankara Hastane | Ankara | 06520 | Turkey (Türkiye) |
| Acibadem Bursa Hastanesi | Bursa | 16059 | Turkey (Türkiye) |
| Ankara Sehir Hastanesi | Dikimevi- Ankara | 06100 | Turkey (Türkiye) |
| Trakya Üniversitesi Sağlık Araştırma ve Uygulama Merkezi | Edirne | Turkey (Türkiye) |
| Bagcilar Medipol Mega Universite Hastanesi | Istanbul | Turkey (Türkiye) |
| T.C. Saglik Bakanligi Goztepe Prof. Dr Suleyman Yalcin Sehir Hastanesi | Kadıköy | Turkey (Türkiye) |
| Acibadem Maslak Hastanesi | Sariyer | Turkey (Türkiye) |
| Gazi Universitesi Gazi Hastanesi | Yenimahalle | Turkey (Türkiye) |
| University Hospital Birmingham NHS Trust, Birmingham Heartlands Hospital | Birmingham | B9 5SS | United Kingdom |
| East Suffolk and North Essex NHS Foundation Trust | Colchester | CO4 5JL | United Kingdom |
| The Beatson West of Scotland Cancer Centre | Glasgow | G12 0YN | United Kingdom |
| St James University Hospital | Leeds | LS9 7TF | United Kingdom |
| Leicester Royal Infirmary | Leicester | LE1 5WW | United Kingdom |
| Barts Health NHS Trust | London | EC1A 7BE | United Kingdom |
| The Christie NHS Foundation | Manchester | M20 4BX | United Kingdom |
| Docetaxel |
Participants received docetaxel 75 mg/m^2, administered as IV infusion on Day 1 of a 21-day treatment cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 19.8 months). |
| COMPLETED |
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| NOT COMPLETED |
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The Intent to Treat (ITT) Analysis Set included all randomized participants according to the treatment arm to which the participant was randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sacituzumab Govitecan (SG) | Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 18.7 months). |
| BG001 | Docetaxel | Participants received docetaxel 75 mg/m^2, administered as IV infusion on Day 1 of a 21-day treatment cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 19.8 months). |
| BG002 | Total~(N=584) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival (OS) | OS is defined as the time from the date of randomization until the date of death from any cause. OS was estimated using Kaplan-Meier estimate. Participants without documentation of death were censored on the date they were last known to be alive. | The Intent to Treat (ITT) Analysis Set included all randomized participants according to the treatment arm to which the participant was randomized. | Posted | Median | 95% Confidence Interval | months | Up to 24.4 months |
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| Secondary | 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 as assessed by RECIST v.1.1. As per RECIST 1.1, PD was defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study), in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or the appearance of of 1 or more new lesions or unequivocal progression of existing non-target lesions. Participants who did not have documented disease progression and did not die were censored at their last tumor assessment date. Kaplan-Meier estimate was used for analysis. | Participants in the ITT Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to 24.4 months |
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| Secondary | Objective Response Rate (ORR) Assessed by Investigator Per RECIST Version 1.1 | ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) that was confirmed at least 4 weeks later as assessed by RECIST v.1.1. As per RECIST 1.1 CR was defined as: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR was defined as: At least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. | Participants in the ITT Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 24.4 months |
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| Secondary | Duration of Response (DOR) Assessed by Investigator Per RECIST Version 1.1 | DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of PD or death from any cause (whichever comes first) as assessed by RECIST v. 1.1. As per RECIST 1.1 CR was disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR was at least 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD, and PD was at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study), in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or the appearance of of 1 or more new lesions or unequivocal progression of existing non-target lesions. Kaplan-Meier estimate was used for analysis. | Participants in the ITT Population who achieved confirmed complete or partial response were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to 24.4 months |
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| Secondary | Disease Control Rate (DCR) Assessed by Investigator Per RECIST Version 1.1 | DCR was defined as the percentage of participants who achieved a CR, PR,or stable disease(SD)as assessed by RECIST v.1.1. Per RECIST 1.1 CR was disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal;PR was at least 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference the smallest sum LD since the treatment started and persistence of 1 or more nontarget lesion(s).PD was at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum measured while on study (this included the baseline sum if that was the smallest on study),in addition of increase of 20% sum also demonstrate an absolute increase of at least 5 mm or appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions. | Participants in the ITT Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 24.4 months |
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| Secondary | Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) | An AE was defined as any untoward medical occurrence in a participants administered a medicinal product that does not necessarily have a causal relationship with this treatment. TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of the study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0. | Not Posted | May 2026 | Up to 3.5 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced Grade 3 or 4 Treatment Emergent Laboratory Abnormalities Post-Baseline | Blood samples were collected for hematology, serum chemistry, and the laboratory abnormalities were assessed. A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last study drug dose plus 30 days.The most severe graded abnormality observed post-baseline for each graded test was counted for each participant. Safety as assessed by grading of laboratory values and AEs according to the National Cancer Institutes' Common Terminology Criteria for Adverse Events (NCI CTCAE) covering grades 0-5 (0=Normal, 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death). The percentage of participants with worst postbaseline grades 3 or 4 will be reported. | Not Posted | May 2026 | Up to 3.5 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Deterioration in Shortness of Breath Domain as Measured by Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) | The NSCLC-SAQ is a participant reported outcome 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" depending on the item's question structure relative to either intensity or frequency, corresponding to a score of 0 to 4, with total score ranging from 0 to 20. The dyspnea (shortness of breath) item uses a "Never(0) to Always(4)" rating scale with higher score indicating higher frequency of dyspnea. Time to deterioration (TTD) was defined as the time from date of randomization to the first date a participant achieves 2-point deterioration from baseline. For shortness of breath domain, a 1-point or greater worsening from baseline represents a clinically meaningful deterioration. Kaplan-Meier estimate was used for analysis. | Participants in the ITT Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to 24.4 months |
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| Secondary | Time to First Deterioration in NSCLC-SAQ Total Score | The NSCLC-SAQ is a participant 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" depending on the item's question structure relative to either intensity or frequency, corresponding to a score of 0 to 4. A total score sums all five domain scores at each visit. If any domain score was missing, the score was not computed. The total score ranges between 0 and 20, with higher scores indicating more severe symptoms. TTD was defined as the time from date of randomization to the first date a participant achieves 2-point deterioration from baseline. For NSCLC-SAQ total score, a 2-point or greater worsening from baseline represents a clinically meaningful deterioration. Kaplan-Meier estimate was used for analysis. | Participants in the ITT Analysis Set were analyzed. | Posted | Median | 95% Confidence Interval | months | Up to 24.4 months |
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All-Cause Mortality and Adverse Events: Up to 24.4 months
Adverse Events: The Safety Analysis Set included all participants who received at least 1 dose of any study drug, with treatment assignments designated according to the actual treatment received.; All-Cause Mortality: The ITT Analysis Set included all randomized participants according to the treatment arm to which the participant was randomized.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sacituzumab Govitecan (SG) | Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 18.7 months). | 168 | 299 | 137 | 296 | 283 | 296 |
| EG001 | Docetaxel | Participants received docetaxel 75 mg/m^2, administered as IV infusion on Day 1 of a 21-day treatment cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 19.8 months). | 187 | 304 | 124 | 288 | 267 | 288 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Duodenal obstruction | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Intestinal pseudo-obstruction | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
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| Neutropenic colitis | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Death, not otherwise specified | General disorders | MedDRA Version 26.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Gait inability | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA Version 26.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA Version 26.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA Version 26.1 | Systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 26.1 | Systematic Assessment |
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| Vascular stent thrombosis | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hepatic pain | Hepatobiliary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Covid-19 pneumonia | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Gastroenteritis clostridial | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Large intestine infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Lower respiratory tract infection fungal | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pleural infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Urinary tract infection staphylococcal | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Fractured coccyx | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Systematic Assessment |
| |
| General physical condition abnormal | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Motor dysfunction | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Bronchial fistula | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Bronchostenosis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Interstitial lung abnormality | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pulmonary toxicity | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Respiratory tract ulceration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA Version 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 26.1 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 12, 2023 | Oct 22, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000608132 | sacituzumab govitecan |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Black |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Other |
|
| Not Reported |
|
| Not Hispanic or Latino |
|
| Not Reported |
|
| France |
|
| United States |
|
| Japan |
|
| Italy |
|
| Germany |
|
| Greece |
|
| Turkey |
|
| Australia |
|
| United Kingdom |
|
| Canada |
|
| Netherlands |
|
| Brazil |
|
| Belgium |
|
| Portugal |
|
| Austria |
|
| Poland |
|
| Israel |
|
| Mexico |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
Participants received docetaxel 75 mg/m^2, administered as IV infusion on Day 1 of a 21-day treatment cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 19.8 months). |
|
|
Participants received docetaxel 75 mg/m^2, administered as IV infusion on Day 1 of a 21-day treatment cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 19.8 months). |
|
|
Participants received docetaxel 75 mg/m^2, administered as IV infusion on Day 1 of a 21-day treatment cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion was met (up to 19.8 months). |
|
|
|
|
|
|