- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06012435
A Study of SGN-B6A Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer
A RANDOMIZED, PHASE 3, OPEN-LABEL STUDY TO EVALUATE SIGVOTATUG VEDOTIN COMPARED WITH DOCETAXEL IN ADULT PARTICIPANTS WITH PREVIOUSLY TREATED NON-SMALL CELL LUNG CANCER (BE6A LUNG-01)
This clinical trial is studying nonsquamous non-small cell lung cancer (NSCLC). Participants in this study must have cancer that has spread through their body or can't be removed with surgery. Participants in this study must have been treated with no more than a platinum-based chemotherapy and an anti-PD-(L)1 drug. Participants with tumors that have certain treatable genomic alterations must have had at least 1 drug for that genomic alteration, in addition to platinum-based chemotherapy.
This clinical trial uses an experimental drug called sigvotatug vedotin, which is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. This clinical trial also uses a drug called docetaxel. Docetaxel is an anticancer drug that has been approved to treat non-small cell lung cancer. It is usually given to patients who previously received another anticancer treatment. In this study, one group of participants will get sigvotatug vedotin on Days 1 and 15 during each 28-day-cycle. A second group of participants will get docetaxel on Day 1 during each 21-day cycle.
This study is being done to see if sigvotatug vedotin works better than docetaxel to treat participants with NSCLC. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Córdoba, Argentina, X5021FPQ
- Sanatorio Allende Cerro
-
San Juan, Argentina, J5400
- Centro Oncológico de Excelencia
-
-
Buenos Aires
-
Mar del Plata, Buenos Aires, Argentina, B7600FZO
- Instituto de Investigaciones clinicas de Mar del Plata
-
-
Cundinamarca
-
Córdoba, Cundinamarca, Argentina, X5008HHW
- CEMAIC - Centro Medico Privado
-
-
Santa Fe Province
-
Rosario, Santa Fe Province, Argentina, S2002KDS
- Hospital Provincial del Centenario
-
Rosario, Santa Fe Province, Argentina, S2000DSV
- Sanatorio Parque
-
-
-
-
New South Wales
-
Albury, New South Wales, Australia, 2640
- Border Medical Oncology Research Unit
-
Waratah, New South Wales, Australia, 2298
- Calvary Mater Newcastle
-
-
Victoria
-
Franskton, Victoria, Australia, 3199
- Peninsula Health, Frankston Hospital
-
Melbourne, Victoria, Australia, 3004
- The Alfred Hospital
-
-
Western Australia
-
Murdoch, Western Australia, Australia, 6150
- St John of God Hospital Murdoch
-
-
-
-
-
Vienna, Austria, A-1020
- Riedl-Prayer-Drahanowsky-Barton Radiologiegruppenpraxis OG (RPDB)- Imagingpraterstern
-
Vienna, Austria, 1090
- Anstaltsapotheke Wiener Gesundheitsverbund Universitatsklinikum AKH Wien
-
Vienna, Austria
- Medizinischen Universitat Wien, Universitatsklinik fur Innere Medizin I
-
-
-
-
-
Brasschaat, Belgium, 2930
- Algemeen Ziekenhuis klina
-
Edegem, Belgium, 2650
- Universitair Ziekenhuis Antwerpen
-
Ghent, Belgium, 9000
- Universitair Ziekenhuis Gent
-
Hasselt, Belgium, 3500
- Jessa Ziekenhuis VZW
-
Liège, Belgium, 4000
- CHU de Liege
-
-
-
-
-
Porto Alegre, Brazil, 90110-270
- Hospital Mae de Deus
-
Salvador, Brazil, 40170-110
- Nucleo de Oncologia da Bahia - Oncoclinicas
-
-
Rio Grande do Sul
-
Ijuí, Rio Grande do Sul, Brazil, 98700-000
- Oncosite - Centro de Pesquisa Clinica E Oncologia
-
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
- União Brasileira de Educação e Assitência (UBEA), mantenedora do Hospital São Lucas da PUCRS
-
-
São Paulo
-
Barretos, São Paulo, Brazil, 14748-400
- Hospital de Cancer de Barretos - Fundacao Pio XII
-
Jaú, São Paulo, Brazil, 17210-080
- Fundação Doutor Amaral Carvalho.
-
Santo André, São Paulo, Brazil, 09060-650
- CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia
-
Vila Olímpia, São Paulo, Brazil, 04538-132
- Centro Paulista de Oncologia S A
-
-
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 5G2
- Arthur J.E. Child Comprehensive Cancer Centre
-
Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
-
-
Ontario
-
Brampton, Ontario, Canada, L6R 3J7
- William Osler Health System - Brampton Civic Hospital.
-
Brampton, Ontario, Canada, L6W 2Z8
- William Osler Health System - Peel Memorial Hospital
-
Etobicoke, Ontario, Canada, M9V 1 R8
- William Osler Health System - Etobicoke General Hospital
-
Ottawa, Ontario, Canada, K1H 8L6
- Ottawa Hospital Cancer Centre
-
Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Research Institute
-
-
Quebec
-
Greenfield Park, Quebec, Canada, J4V 2H1
- CISSS de la Monteregie-Centre
-
Montreal, Quebec, Canada, H2X 0C1
- Centre Hospitalier de l'Universite de Montreal
-
Montreal, Quebec, Canada, H4A 3J1
- McGill University Health Centre
-
Montreal, Quebec, Canada, H2X 0A9
- Centre Hospitalier de l'Universite de Montreal
-
Montreal, Quebec, Canada, H3H 2R9
- The Research Institute of the McGill University Health Centre
-
-
-
-
Santiago Metropolitan
-
Recoleta, Santiago Metropolitan, Chile
- Centro de Investigacion Clinica Bradford Hill
-
Santiago, Santiago Metropolitan, Chile, 8331143
- CeCim Biocinetic
-
-
-
-
-
Beijing, China, 101149
- Beijing Chest Hospital, Capital Medical University
-
Beijing, China, 100142
- Beijing Cancer Hospital
-
Chongqing, China, 400030
- Chongqing University Cancer Hospital
-
Shanghai, China, 200032
- Fudan University Shanghai Cancer Center
-
-
Anhui
-
Hefei, Anhui, China, 230022
- The First Affiliated Hospital of Anhui Medical University
-
-
Fujian
-
Fuzhou, Fujian, China, 350014
- Fujian Provincial Cancer Hospital
-
-
Guangdong
-
Foshan, Guangdong, China, 528000
- The First People's Hospital of Foshan
-
Guangzhou, Guangdong, China, 510080
- Guangdong Provincial People's Hospital
-
Jiangmen, Guangdong, China, 529000
- Jiangmen Central Hospital
-
-
Guangxi
-
Nanning, Guangxi, China, 530021
- Guangxi Medical University Affiliated Tumor Hospital
-
Nanning, Guangxi, China, 530201
- Guangxi Medical University Affiliated Tumor Hospital
-
-
Henan
-
Luoyang, Henan, China, 471000
- The First Affiliated Hospital of Henan University of Science &Technology
-
Luoyang, Henan, China
- The First Affiliated Hospital of Henan University of Science &Technology
-
Zhengzhou, Henan, China, 450008
- Henan Cancer Hospital
-
-
Hubei
-
Wuhan, Hubei, China, 430048
- Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
-
-
Hunan
-
Changsha, Hunan, China, 410013
- Hunan Cancer Hospital
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210029
- Jiangsu Province Hospital
-
-
Jiangxi
-
Nanchang, Jiangxi, China, 330006
- The First Affiliated Hospital of NanChang University
-
Nanchang, Jiangxi, China, 330200
- The First Affiliated Hospital of NanChang University
-
-
Jilin
-
Changchun, Jilin, China, 130012
- Jilin Cancer Hospital
-
-
Shandong
-
Jinan, Shandong, China, 250117
- Shandong Cancer Hospital
-
Linyi, Shandong, China, 276034
- Linyi Cancer Hospital
-
-
Shannxi
-
Xi'an, Shannxi, China, 710061
- First Affiliated Hospital of Xi 'an Jiaotong University
-
-
Sichuan
-
Chengdu, Sichuan, China, 610213
- Sichuan Province Cancer Hospital
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, China, 300060
- Tianjin cancer hospital
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310022
- Zhejiang Cancer Hospital
-
Hangzhou, Zhejiang, China, 310003
- The First Affiliated Hospital Zhejiang University School of Medicine
-
Hangzhou, Zhejiang, China, 310016
- Sir Run Run Shaw Hospital
-
Taizhou, Zhejiang, China, 317000
- Taizhou Hospital of Zhejiang Province
-
-
-
-
-
Ostrava, Czechia, 70300
- Nemocnice AGEL Ostrava Vitkovice a.s.,
-
Prague, Czechia, 128 08
- Vseobecna fakultni nemocnice v Praze
-
-
-
-
-
Besançon, France, 25030
- CHU de Besancon - Hopital Jean Minjoz
-
Cholet, France, 49300
- Centre Hospitalier de Cholet
-
Créteil, France, 94010
- Centre Hospitalier Intercommunal de Creteil
-
Lille, France, 59037
- CHRU de Lille
-
Marseille, France, 13015
- Hopital Nord - Batiment Mistral
-
Montpellier, France, 34070
- Centre de Cancerologie du Grand Montpellier
-
Montpellier, France, 34070
- Service UPCC, R-1, Clinique Clementville
-
Paris, France, 75018
- Hopital Bichat-Claude Bernard
-
Paris, France, 75014
- Hopital Cochin, APHP Centre Universite de Paris
-
Pessac, France, 33604
- CHU de Bordeaux, Hopital du Haut-Leveque, Centre Francois Magendie
-
Quimper, France, 29000
- CH de Cornouaille
-
Rennes, France, 35033
- CHU de Rennes - Hopital Pontchaillou
-
Strasbourg, France, 67033
- Centre de Lutte contre le Cancer Paul Strauss - CPS
-
Toulon, France, 83000
- Hôpital Sainte Musse
-
Toulouse, France, 31059
- CHU Toulouse - Hopital Larrey
-
Villejuif, France, 94805
- IGR Gustave Roussy
-
-
-
-
-
Bonn, Germany, 53113
- Johanniter Krankenhaus Bonn
-
Esslingen am Neckar, Germany, 73730
- Klinikum Esslingen GmbH
-
Frankfurt a.M., Germany, 60590
- Universitatsklinikum Frankfurt
-
Gauting, Germany, 82131
- Asklepios Klinik Gauting GmbH
-
Großhansdorf, Germany, 22927
- LungenClinic Grosshansdorf
-
Heidelberg, Germany, D-69126
- Thoraxklinik Heidelberg gGmbH
-
-
Other
-
Halle, Other, Germany, 06120
- Krankenhaus Martha-Maria Halle-Dölau GmbH
-
-
-
-
-
Athens, Greece, 11526
- Henry Dunant Hospital Center
-
Larissa, Greece, 41110
- University General Hospital of Larisa
-
N.Faliro, Greece, 18547
- Metropolitan Hospital
-
Pilea Thessaloniki, Greece, 555 35
- Interbalkan Medical Center
-
Pátrai, Greece, 26504
- General University Hospital of Patras
-
Thessaloniki, Greece, 55236
- St. Luke s Hospital
-
-
Attikí
-
Athens, Attikí, Greece, 11528
- General Hospital of Athens Alexandra
-
-
-
-
-
Jerusalem, Israel, 9103102
- Shaare Zedek Medical Center
-
Kfar Saba, Israel, 4428164
- Meir Medical Center
-
Petah Tikva, Israel, 4941492
- Rabin Medical Center
-
Rehovot, Israel, 7661041
- Kaplan Medical Center
-
-
Other
-
Tel Aviv, Other, Israel, 6423906
- Tel Aviv Sourasky Medical Center
-
-
-
-
-
Ancona, Italy, 60126
- Azienda Ospedaliero Universitaria delle Marche
-
Aviano (PN), Italy, 33081
- Centro di Riferimento Oncologico (CRO) IRCCS
-
Caserta, Italy, 81100
- AORN Sant'anna e San Sebastiano
-
Catania, Italy, 95123
- A.O.U Policlinico G. Rodolico S. Marco
-
Milan, Italy, 20132
- IRCCS Ospedale San Raffaele
-
Parma, Italy, 43126
- UOC Oncologia Medica - Azienda Ospedaliero - Universitaria di Parma
-
Roma, Italy, 00168
- Fondazione Policlinico Gemelli
-
Rome, Italy, 53-00144
- Radiologia
-
Rome, Italy, 53-00144
- Sperimentazioni cliniche fase 1
-
-
Emilia-Romagna
-
Meldola (Fc), Emilia-Romagna, Italy, 47014
- IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l
-
-
Lombardy
-
Milan, Lombardy, Italy, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori
-
-
MB
-
Monza, MB, Italy, 20900
- U.O.C. Centro di Ricerca di Fase 1, Fondazione IRCCS San Gerardo dei Tintori
-
Monza, MB, Italy, 20900
- U.O.C. Oncologia Medica, Fondazione IRCCS San Gerardo dei Tintori
-
-
Other
-
Genova, Other, Italy, 16132
- Irccs Azienda Ospedaliera Metropolitana (Aom)
-
-
Province OF Brescia
-
Brescia, Province OF Brescia, Italy, 25123
- Azienda Ospedaliera Spedali Civili di Brescia
-
-
ROME
-
Roma, ROME, Italy, 00144
- Farmacia
-
Roma, ROME, Italy, 00144
- IRCCS Istituto Nazionale dei Tumori Regina Elena
-
-
-
-
Aichi-ken
-
Nagoya, Aichi-ken, Japan, 464-8681
- Aichi Cancer Center
-
-
Chiba
-
Kashiwa-shi, Chiba, Japan, 277-8577
- National Cancer Center Hospital East
-
-
Ehime
-
Matsuyama, Ehime, Japan, 791-0280
- NHO Shikoku Cancer Center
-
-
Fukuoka
-
Kurume, Fukuoka, Japan, 830-0011
- Kurume University Hospital
-
-
Gunma
-
Ota-Shi, Gunma, Japan, 373-8550
- Gunma Prefectural Cancer Center
-
-
Hyōgo
-
Kobe, Hyōgo, Japan, 650-0047
- Kobe City Hospital Organization Kobe City Medical Center General Hospital
-
-
Ishikawa-ken
-
Kanazawa, Ishikawa-ken, Japan, 920-8641
- Kanazawa University Hospital
-
-
Kanagawa
-
Yokohama, Kanagawa, Japan, 241-8515
- Kanagawa Cancer Center
-
-
Niigata
-
Niigata, Niigata, Japan, 951-8566
- Niigata Cancer Center Hospital
-
-
Osaka
-
Sakai, Osaka, Japan, 590-0197
- Kindai University Hospital
-
Takatsuki-shi, Osaka, Japan, 569-8686
- Osaka Medical and Pharmaceutical University Hospital
-
-
Other
-
Osaka, Other, Japan, 541-8567
- Osaka International Cancer Institute
-
-
Shizuoka
-
Sunto-gun, Shizuoka, Japan, 411-8777
- Shizuoka Cancer Center
-
-
Tokyo
-
Bunkyo-ku, Tokyo, Japan, 113-8677
- Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
-
Bunkyo-ku, Tokyo, Japan, 113-8603
- Nippon Medical School Hospital
-
Chuo-ku, Tokyo, Japan, 104-0045
- National Cancer Center Hospital
-
Koto-ku, Tokyo, Japan, 135-8550
- The Cancer Institute Hospital of JFCR
-
-
-
-
-
Groningen, Netherlands, 9728 NT
- Martini Ziekenhuis
-
Maastricht, Netherlands, 6229 HX
- Maastricht UMC
-
Rotterdam, Netherlands, 3015 GD
- Erasmus Medisch Centrum Daniel Den Hoed
-
-
-
-
-
Drammen, Norway, 3004
- Vestre Viken Health Trust - Drammen Hospital
-
Oslo, Norway, 0379
- Oslo University Hospital (OUH) - The Norwegian Radium Hospital
-
Oslo, Norway, 0379
- Sykehusapoteket Oslo, Radiumhospitalet - Avdeling Produksjon
-
Oslo, Norway, NO-0450
- Oslo University Hospital
-
-
-
-
-
Gdansk, Poland, 80-214
- Uniwersyteckie Centrum Kliniczne
-
Lodz, Poland, 90-302
- Instytut MSF Sp. z.o.o.
-
Lublin, Poland, 20-609
- Institute of Genetics and Immunology GENIM LCC
-
Poznan, Poland, 60-693
- Med-Polonia Sp. z.o.o.
-
-
-
-
-
Bucharest, Romania, 013823
- Memorial Healthcare International S.R.L
-
Craiova, Romania, 200542
- Centrul de Oncologie Sf Nectarie
-
-
Cluj
-
Cluj-Napoca, Cluj, Romania, 400641
- S.C. Medisprof S.R.L
-
-
Constanța County
-
Ovidiu, Constanța County, Romania, 905900
- Ovidius Clinical Hospital
-
-
Koblenz
-
Cluj-Napoca, Koblenz, Romania, 400015
- Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj-Napoca
-
-
Sector 3
-
Bucharest, Sector 3, Romania, 030463
- SC Policlinica CCBR SRL
-
-
Timiș County
-
Timișoara, Timiș County, Romania, 300166
- S.C. Oncocenter Oncologie Clinica S.R.L, Sectia Oncologie Medicala
-
-
-
-
Gyeonggi-do
-
Suwon, Gyeonggi-do, South Korea, 16499
- Ajou University Hospital.
-
-
Gyeonggido [kyonggi-do]
-
Suwon, Gyeonggido [kyonggi-do], South Korea, 16247
- St. Vincent's Hospital, The Catholic University of Korea.
-
-
-
-
-
Alicante, Spain, 03010
- Hospital General Universitario de Alicante - Farmacia
-
Badalona, Spain, 08919
- lnstitut Catala D'oncologia (ICO) Badalona - Hospital Universitari Germans Trias I Pujol
-
Barcelona, Spain, 08035
- Hospital Universitari Vall d'Hebron
-
Castellon, Spain, 12002
- Consorcio Hospitalario Provincial de Castellon
-
Madrid, Spain, 28040
- Hospital Clinico San Carlos
-
Madrid, Spain, 28041
- Hospital Universitario 12 de Octubre
-
Madrid, Spain, 28007
- Hospital General Universitario Gregorio Marañon
-
Madrid, Spain, 28040
- Servicio de Farmacia Hospitalaria
-
Málaga, Spain, 129004
- Hospital Quironsalud Malaga
-
Valencia, Spain, 46026
- Hospital Universitari i Politecnic La Fe
-
Valencia, Spain, 46009
- Fundación Instituto Valenciano de Oncología (FIVO)
-
Zaragoza, Spain, 50009
- Hospital Clinico Universitario Lozano Blesa de Zaragoza
-
-
Balearic Islands
-
Palma, Balearic Islands, Spain, 07120
- Hospital Universitario Son Espases
-
-
Galicia
-
A Coruña, Galicia, Spain, 15006
- Complejo Hospitalario Universitario La Coruna
-
-
Other
-
Barcelona, Other, Spain, 08029
- CETIR Viladomat
-
-
Valencia
-
Alicante, Valencia, Spain, 03010
- Hospital General Universitario Alicante
-
-
-
-
-
Basel, Switzerland, 4031
- Universitatsspital Basel
-
Bern, Switzerland, 3010
- Inselspital
-
Lausanne, Switzerland, 1011
- University Hospital Lausanne CHUV
-
Zurich, Switzerland, CH-8091
- Universitatsspital Zurich
-
Zurich, Switzerland, 8091
- Universitatsspital Zurich
-
Zurich, Switzerland, 8091
- Universitatsspital Zurich, Institut fur diagnostische und interventionelle Radiologie
-
-
Graubünden (DE)
-
Chur, Graubünden (DE), Switzerland, 7000
- Kantonsspital Graubünden/Medizinische Onkologie und Hämatologie
-
Chur, Graubünden (DE), Switzerland, 7000
- Kantonsspital Graubuenden
-
-
Other
-
Chur, Other, Switzerland, 7000
- Kantonsspital Graubuenden
-
-
-
-
-
Changhua, Taiwan, 500
- Changhua Christian Medical Foundation Changhua Christian Hospital
-
Kaohsiung City, Taiwan, 807
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
Kaohsiung City, Taiwan, 82445
- E-DA Hospital
-
Taipei, Taiwan, 11217
- Taipei Veterans General Hospital
-
-
Yunlin
-
Douliu, Yunlin, Taiwan, 640
- National Taiwan University Hospital Yunlin Branch
-
-
-
-
-
Glasgow, United Kingdom, G12 0YN
- The Beatson West of Scotland Cancer Centre
-
London, United Kingdom, W1G 6AD
- Sarah Cannon Research Institute UK
-
London, United Kingdom, W1G 7LJ
- The Harley Street Clinic
-
London, United Kingdom, W1G 8PP
- The Harley Street Clinic
-
London, United Kingdom, SW3 6JJ
- The Royal Marsden NHS Foundation Trust (RM).
-
London, United Kingdom, EC 1A 7BE
- St. Bartholomew's Hospital - Barts Health NHS Trust
-
Manchester, United Kingdom, M20 4BX
- The Christie Nhs Foundation Trust
-
Sutton, United Kingdom, SM2 5PT
- Royal Marsden Hospital Sutton
-
-
Other
-
London, Other, United Kingdom, W1G 8BJ
- The Harley Street Clinic (THSC)
-
-
Others
-
London, Others, United Kingdom, W1G 7AF
- Diagnostic Centre
-
-
Scotland
-
Glasgow, Scotland, United Kingdom, G12 0XH
- J B Russell House, Gartnavel Royal Hospital
-
-
-
-
Alaska
-
Anchorage, Alaska, United States, 99508
- Alaska Oncology and Hematology, Llc
-
-
California
-
Fullerton, California, United States, 92835
- Providence Medical Foundation
-
Fullerton, California, United States, 92835
- Providence St. Jude Medical Center
-
Fullerton, California, United States, 92835
- Providence St. Jude Medical Center Virginia K. Crosson Cancer Center and Infusion Center
-
Los Alamitos, California, United States, 90720
- Cancer and Blood Specialty Clinic
-
Los Alamitos, California, United States, 90720
- Cancer Blood and Specialty Clinic
-
Los Angeles, California, United States, 90095
- Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L Wong, Pharm.D.
-
Los Angeles, California, United States, 90024
- Regulatory Management Only: TRIO-US Central Administration
-
Los Angeles, California, United States, 90095
- Drug Management Only: UCLA West Medical Pharmacy Attn: Steven L. Wong, Pharma.D.
-
San Francisco, California, United States, 94158
- UCSF Medical Center - Mission Bay
-
Santa Barbara, California, United States, 93105
- Sansum Clinic
-
Solvang, California, United States, 93463
- Sansum Clinic
-
-
Colorado
-
Aurora, Colorado, United States, 80012
- Rocky Mountain Cancer Centers LLP
-
Boulder, Colorado, United States, 80303
- Rocky Mountain Cancer Centers LLP
-
Colorado Springs, Colorado, United States, 80907
- Rocky Mountain Cancer Centers LLP
-
Colorado Springs, Colorado, United States, 80923
- Rocky Mountain Cancer Centers LLP
-
Denver, Colorado, United States, 80218
- Rocky Mountain Cancer Centers LLP
-
Denver, Colorado, United States, 80220
- Rocky Mountain Cancer Centers LLP
-
Lakewood, Colorado, United States, 80228
- Rocky Mountain Cancer Centers LLP
-
Littleton, Colorado, United States, 80120
- Rocky Mountain Cancer Centers LLP
-
Lone Tree, Colorado, United States, 80124
- Rocky Mountain Cancer Centers LLP
-
Longmont, Colorado, United States, 80504
- Rocky Mountain Cancer Centers LLP
-
Pueblo, Colorado, United States, 81003
- Rocky Mountain Cancer Centers LLP
-
Thornton, Colorado, United States, 80260
- Rocky Mountain Cancer Centers LLP
-
-
Florida
-
Fleming Island, Florida, United States, 32003
- Cancer Specialists of North Florida
-
Jacksonville, Florida, United States, 32256
- Cancer Specialists of North Florida
-
Jacksonville, Florida, United States, 32204
- Cancer Specialists of North Florida
-
Jacksonville, Florida, United States, 32258
- Cancer Specialists of North Florida
-
Jacksonville, Florida, United States, 32218
- Cancer Specialists of North Florida
-
Melbourne, Florida, United States, 32935
- Cancer Care Centers of Brevard, Inc.
-
Miami, Florida, United States, 33176
- Baptist Hospital of Miami
-
Miami, Florida, United States, 33176
- Miami Cancer Institute at Baptist Health, Inc.
-
Neptune Beach, Florida, United States, 32266
- Cancer Specialists of North Florida
-
Palm Bay, Florida, United States, 32901
- Cancer Care Centers of Brevard, Inc.
-
Rockledge, Florida, United States, 32955
- Cancer Care Centers of Brevard, Inc.
-
Saint Augustine, Florida, United States, 32086
- Cancer Specialists of North Florida
-
-
Illinois
-
Arlington Heights, Illinois, United States, 60005
- Illinois Cancer Specialists
-
Niles, Illinois, United States, 60714
- Illinois Cancer Specialists
-
-
Maryland
-
Annapolis, Maryland, United States, 21401
- Maryland Oncology Hematology P.A.
-
Bethesda, Maryland, United States, 20817
- Maryland Oncology Hematology P.A.
-
Brandywine, Maryland, United States, 20613
- Maryland Oncology Hematology P.A.
-
Columbia, Maryland, United States, 21044
- Maryland Oncology Hematology P.A.
-
Germantown, Maryland, United States, 20876
- Maryland Oncology Hematology P.A.
-
Largo, Maryland, United States, 20774
- Maryland Oncology Hematology P.A.
-
Rockville, Maryland, United States, 20850
- Maryland Oncology Hematology P.A.
-
Silver Spring, Maryland, United States, 20904
- Maryland Oncology Hematology P.A.
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
-
Boston, Massachusetts, United States, 02118
- Boston Medical Center
-
Fairhaven, Massachusetts, United States, 02719
- Southcoast Centers for Cancer Care
-
Fall River, Massachusetts, United States, 02720
- Southcoast Centers for Cancer Care
-
-
Minnesota
-
Coon Rapids, Minnesota, United States, 55433
- Allina Health Cancer Institute - Mercy Hospital
-
Minneapolis, Minnesota, United States, 55407
- Allina Health Cancer Institute - Abbott Northwestern Hospital
-
Saint Paul, Minnesota, United States, 55102
- Allina Health Cancer Institute - United Hospital
-
-
Mississippi
-
Hattiesburg, Mississippi, United States, 39401
- Hattiesburg Clinic Hematology/Oncology.
-
-
Missouri
-
Kansas City, Missouri, United States, 64111
- St Luke's Cancer Institute
-
-
Nebraska
-
Bellevue, Nebraska, United States, 68123
- Nebraska Medicine
-
Omaha, Nebraska, United States, 68198
- University of Nebraska Medical Center
-
Omaha, Nebraska, United States, 68105
- Nebraska Medicine
-
Omaha, Nebraska, United States, 68118
- Nebraska Medicine
-
-
New Jersey
-
Berkeley Heights, New Jersey, United States, 07922
- Summit Medical Group
-
Clifton, New Jersey, United States, 07013
- Summit Medical Group
-
Florham Park, New Jersey, United States, 07932
- Summit Medical Group
-
-
New York
-
Mineola, New York, United States, 11501
- NYU Langone Hospital - Long Island
-
Mineola, New York, United States, 11501
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island
-
New York, New York, United States, 10016
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
-
New York, New York, United States, 10016
- NYU Langone Medical Center (Tisch Hospital)
-
New York, New York, United States, 10016
- Laura & Isaac Perlmutter Cancer Center - NYU ACC
-
-
Ohio
-
Avon, Ohio, United States, 44011
- University Hospitals Seidman Cancer Center at UH Avon Health Center
-
Cincinnati, Ohio, United States, 45242
- Oncology Hematology Care Clinical Trials, LLC
-
Cincinnati, Ohio, United States, 45245
- Oncology Hematology Care Clinical Trials, LLC
-
Cincinnati, Ohio, United States, 45211
- Oncology Hematology Care Clinical Trials, LLC
-
Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center
-
Cleveland, Ohio, United States, 44111
- Cleveland Clinic Cancer Center/Fairview Hospital Moll Cancer Pavilion
-
Fairfield, Ohio, United States, 45014
- Oncology Hematology Care Clinical Trials, LLC
-
Maumee, Ohio, United States, 43537
- Taylor Cancer Research Center
-
Mayfield Heights, Ohio, United States, 44124
- Cleveland Clinic Cancer Center/Hillcrest Hospital Cancer Center Pharmacy
-
Mentor, Ohio, United States, 44060
- University Hospitals Seidman Cancer Center at UH Mentor Health Center
-
Orange, Ohio, United States, 44122
- UH Minoff Health Center at Chagrin Highlands
-
-
Oregon
-
Beaverton, Oregon, United States, 97006
- Oregon Health and Science University - CHO Beaverton
-
Eugene, Oregon, United States, 97401
- Oncology Associates of Oregon, P.C.
-
Gresham, Oregon, United States, 97030
- Oregon Health and Science University - CHO Gresham
-
Portland, Oregon, United States, 97239
- Oregon Health and Science University
-
Portland, Oregon, United States, 97227
- Northwest Cancer Specialists, P.C.
-
Portland, Oregon, United States, 97213
- Northwest Cancer Specialists, P.C.
-
Portland, Oregon, United States, 97210
- Oregon Health and Science University - CHO Northwest
-
Portland, Oregon, United States, 97216
- Oregon Health and Science University - CHO East Portland
-
Portland, Oregon, United States, 97239
- Oregon Health and Science University (CHH1)
-
Portland, Oregon, United States, 97239
- Oregon Health and Science University (CHH2)
-
Tigard, Oregon, United States, 97223
- Northwest Cancer Specialists, P.C.
-
Tualatin, Oregon, United States, 97062
- Oregon Health and Science University - CHO Tualatin
-
-
Pennsylvania
-
Bensalem, Pennsylvania, United States, 19020
- Alliance Cancer Specialists, PC
-
Doylestown, Pennsylvania, United States, 18901
- Alliance Cancer Specialists, PC
-
Horsham, Pennsylvania, United States, 19044
- Alliance Cancer Specialists, PC
-
Langhorne, Pennsylvania, United States, 19047
- Alliance Cancer Specialists, PC
-
Media, Pennsylvania, United States, 19063
- Alliance Cancer Specialists, PC
-
Sellersville, Pennsylvania, United States, 18960
- Alliance Cancer Specialists, PC
-
Wynnewood, Pennsylvania, United States, 19096
- Alliance Cancer Specialists, PC
-
-
Texas
-
Abilene, Texas, United States, 79606
- Texas Oncology - West Texas
-
Amarillo, Texas, United States, 79124
- Texas Oncology - West Texas
-
Austin, Texas, United States, 78731
- Texas Oncology - Central South
-
Austin, Texas, United States, 78745
- Texas Oncology - Central South
-
Austin, Texas, United States, 78705
- Texas Oncology - Central South
-
Dallas, Texas, United States, 75390
- University of Texas Southwestern Medical Center
-
Dallas, Texas, United States, 75235
- University of Texas Southwestern Medical Center - Simmons Cancer Center
-
Dallas, Texas, United States, 75237
- UT Southwestern Medical Center - Redbird
-
Dallas, Texas, United States, 75390
- Univ. of TX Southwestern Medical Center - Zale Lipshy University Hospital
-
Dallas, Texas, United States, 75390
- University of Texas Southwestern Medical Center - William P. Clements, Jr., University Hospital
-
El Paso, Texas, United States, 79902
- Texas Oncology - West Texas
-
El Paso, Texas, United States, 79915
- Texas Oncology - West Texas
-
El Paso, Texas, United States, 79938
- Texas Oncology - West Texas
-
Fort Worth, Texas, United States, 76104
- UT Southwestern - Simmons Cancer Center - Fort Worth
-
Irving, Texas, United States, 75063
- US Oncology Investigational Products Center (IPC)
-
Irving, Texas, United States, 75063
- US Oncology Investigational Product Center (IPC)
-
Midland, Texas, United States, 79701
- Texas Oncology - West Texas
-
Odessa, Texas, United States, 79761
- Texas Oncology - West Texas
-
Richardson, Texas, United States, 75080
- UT Southwestern - Simmons Cancer Center - Richardson/Plano
-
Waco, Texas, United States, 76712
- Texas Oncology - Central South
-
Wichita Falls, Texas, United States, 76310
- Texas Oncology - West Texas
-
-
Virginia
-
Blacksburg, Virginia, United States, 24060
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
-
Low Moor, Virginia, United States, 24457
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
-
Roanoke, Virginia, United States, 24014
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
-
Salem, Virginia, United States, 24153
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
-
Wytheville, Virginia, United States, 24382
- Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
-
-
Washington
-
Bonney Lake, Washington, United States, 98391
- NorthWest Medical Specialties, PLLC
-
Federal Way, Washington, United States, 98003
- NorthWest Medical Specialties, PLLC
-
Gig Harbor, Washington, United States, 98332
- NorthWest Medical Specialties, PLLC
-
Olympia, Washington, United States, 98506
- American Oncology Network Vista Oncology Division
-
Olympia, Washington, United States, 98502
- American Oncology Network Vista Oncology Division-West office
-
Puyallup, Washington, United States, 98373
- NorthWest Medical Specialties, PLLC
-
Tacoma, Washington, United States, 98405
- NorthWest Medical Specialties, PLLC
-
Vancouver, Washington, United States, 98684
- Northwest Cancer Specialists, P.C.
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Froedtert Hospital/Medical College of Wisconsin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of locally advanced, unresectable (Stage IIIB, IIIC), or metastatic Stage IV (M1a, M1b, or M1c) NSCLC American Joint Committee on Cancer (AJCC) Staging Manual, Version 8.0, and the Union for International Cancer Control (UICC) Staging System (Eighth edition).
Participants must have NSCLC with nonsquamous histology
- Tumors with squamous, or predominantly squamous histology are excluded.
- Tumors with small cell elements are excluded.
- Participants who have NSCLC with known actionable genomic alteration (AGAs) are permitted
Participants must have received the following prior therapies and progressed during or relapsed after receiving their most recent prior therapy:
Participants with no known AGAs must fulfill 1 of the following conditions:
- Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease and a PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy), unless contraindicated.
- Experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant or neoadjuvant setting and received a PD-(L)1 monoclonal antibody at any time during the course of treatment.
Participants with known AGAs must fulfill the following conditions:
- Must have received at least 1 relevant AGA targeted therapy and in the opinion of the investigator, additional AGA targeted therapy is not in the best interest of the participant.
- Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease, or experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant or neoadjuvant setting
- May have received up to 1 PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy).
- Measurable disease based on RECIST v1.1
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with adequate baseline hematologic, hepatic, and renal function and measurable disease according to RECIST v1.1
Exclusion Criteria:
- Life expectancy of less than (<) 3 months
- Known allergies/hypersensitivity/intolerance to or contraindication of taxanes, docetaxel, or any excipient contained in the drug formulation of sigvotatug vedotin
- History of another malignancy within 3 years before Cycle 1 Day 1, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death
Participants with any of the following respiratory conditions:
Evidence of noninfectious interstitial lung disease (ILD) or pneumonitis that:
- Was previous diagnosed and required systemic steroids, or
- Is currently diagnosed and managed, or
- Is suspected on radiologic imaging at screening
- Known diffusing capacity of the lung for carbon monoxide (DLCO) < 50%
- Any Grade greater than or equal to (≥) 3 pulmonary disease unrelated to underlying malignancy
- Pre-existing peripheral neuropathy Grade greater than or equal to (≥) 2
- Uncontrolled diabetes mellitus
Prior therapy:
- Prior treatment with antimicrotubule agents (taxanes, vinca alkaloids, or MMAEs) in the locally advanced, unresectable/refractory, or metastatic setting
- Prior antimicrotubule agent exposure in curative settings (including adjuvant, neoadjuvant, or chemoradiotherapy) is permissible.
- Received more than 1 prior line of cytotoxic chemotherapy in the locally advanced, unresectable/refractory, or metastatic setting
- Prior cytotoxic chemotherapy in curative settings is permissible
- At least 14 days must have elapsed from the last dose of radiotherapy until Cycle 1 Day 1.
- Prior radiation therapy to the lung parenchyma that is >30 Gray (Gy) within 6 months of Cycle 1 Day 1.
- Any systemic anticancer therapy (standard or experimental) within 21 days prior to Cycle 1 Day 1.
Active central nervous system (CNS) lesions, including leptomeningeal metastasis, are excluded. Participants with definitively treated brain metastases are eligible in they meet the following criteria:
- Have been clinically stable for at least 4 weeks prior to treatment initiation and baseline scans show no evidence of new or enlarged metastasis
- On a stable dose of less than or equal to (≤) 10mg/day of prednisone or equivalent for a least 2 weeks (if requiring steroid treatment)
- Treatment with corticosteroids greater than (>) 1 month prior to Screening visit
- No evidence of clinical and radiographic disease progression in the CNS for ≥ 21 days after definitive radiotherapy and/or surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Arm
Docetaxel monotherapy
|
75 mg/m^2 given into the vein (IV; intravenously) on Day 1 of a 21-day cycle
|
|
Experimental: Experimental Arm
sigvotatug vedotin monotherapy
|
Given into the vein (IV; intravenously) on Day 1 and 15 of a 28-day cycle
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival (OS) between the experimental arm (sigvotatug vedotin) and control arm (docetaxel)
Time Frame: Approximately 5 years
|
The time from date of randomization to date of death due to any cause.
|
Approximately 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PFS per RECIST v1.1 by investigator assessment
Time Frame: Approximately 5 years
|
The time from date of randomization to the first documented disease progression per RECIST v1.1 or to death due to any cause.
|
Approximately 5 years
|
|
Duration of Response (DOR) per RECIST v1.1 by BICR
Time Frame: Approximately 5 years
|
The time from the first documented objective response (CR or PR that is subsequently confirmed) to the first documented disease progression per RECIST v1.1 or to death due to any cause.
|
Approximately 5 years
|
|
DOR per RECIST v1.1 by investigator assessment
Time Frame: Approximately 5 years
|
The time from the first documented objective response (CR or PR that is subsequently confirmed) to the first documented disease progression per RECIST v1.1 or to death due to any cause.
|
Approximately 5 years
|
|
Number of participants with adverse events (AEs)
Time Frame: Through 30 days after the last study intervention; Approximately 5 years
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
|
Through 30 days after the last study intervention; Approximately 5 years
|
|
Mean score in the global health status/QoL combined score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Time Frame: Approximately 5 years
|
The EORTC QLQ-C30 was developed as a quantitative measure of health-related quality of life (HRQoL).
Scores range from 0 to 100.
A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
|
Approximately 5 years
|
|
Change from baseline in global health status/QoL combined score on the EORTC QLQ-C30
Time Frame: Approximately 5 years
|
The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL.
Scores range from 0 to 100.
A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
|
Approximately 5 years
|
|
Mean score in physical functioning scores on the EORTC QLQ-C30
Time Frame: Approximately 5 years
|
The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL.
Scores range from 0 to 100.
A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
|
Approximately 5 years
|
|
Change from baseline score in physical functioning scores on the EORTC QLQ-C30
Time Frame: Approximately 5 years
|
The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL.
Scores range from 0 to 100.
A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
|
Approximately 5 years
|
|
Mean score in role functioning scores on the EORTC QLQ-C30
Time Frame: Approximately 5 years
|
The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL.
Scores range from 0 to 100.
A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
|
Approximately 5 years
|
|
Change from baseline score in role functioning scores on the EORTC QLQ-C30
Time Frame: Approximately 5 years
|
The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL.
Scores range from 0 to 100.
A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
|
Approximately 5 years
|
|
Mean scores in the dyspnea, cough, and chest pain scores on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13)
Time Frame: Approximately 5 years
|
The EORTC QLQ-LC13 is a lung-cancer specific module that serves as an additional 13 item questionnaire to the general EORTC cancer questionnaire.
It incorporates 1 multi-item scale to assess dyspnea, and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis.
Scores range from 0 to 100.
A high score for a symptom scale/item represents a high level of symptomatology/problems.
|
Approximately 5 years
|
|
Change from baseline in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13
Time Frame: Approximately 5 years
|
The EORTC QLQ-LC13 is a lung-cancer specific module that serves as an additional 13 item questionnaire to the general EORTC cancer questionnaire.
It incorporates 1 multi-item scale to assess dyspnea, and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis.
Scores range from 0 to 100.
A high score for a symptom scale/item represents a high level of symptomatology/problems.
|
Approximately 5 years
|
|
Time to Deterioration (TTD) in the global health status/QoL combined score on the EORTC QLQ-C30
Time Frame: Approximately 5 years
|
TTD is defined as the time from date of randomization to first onset of PRO deterioration with or without subsequent confirmation.
The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL.
Scores range from 0 to 100.
A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
|
Approximately 5 years
|
|
TTD in physical functioning scores on the EORTC QLQ-C30
Time Frame: Approximately 5 years
|
TTD is defined as the time from date of randomization to first onset of PRO deterioration with or without subsequent confirmation.
The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL.
Scores range from 0 to 100.
A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
|
Approximately 5 years
|
|
TTD in role functioning scores on the EORTC QLQ-C30
Time Frame: Approximately 5 years
|
TTD is defined as the time from date of randomization to first onset of PRO deterioration with or without subsequent confirmation.
The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL.
Scores range from 0 to 100.
A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
|
Approximately 5 years
|
|
TTD in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13
Time Frame: Approximately 5 years
|
TTD is defined as the time from date of randomization to first onset of PRO deterioration with or without subsequent confirmation.
The EORTC QLQ-LC13 is a lung-cancer specific module that serves as an additional 13 item questionnaire to the general EORTC cancer questionnaire.
It incorporates 1 multi-item scale to assess dyspnea, and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis.
Scores range from 0 to 100.
A high score for a symptom scale/item represents a high level of symptomatology/problems.
|
Approximately 5 years
|
|
Confirmed ORR per RECIST v1.1 by investigator assessment
Time Frame: Approximately 5 years
|
The proportion of participants with confirmed CR or PR according to RECIST v1.1.
|
Approximately 5 years
|
|
Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) as assessed by Blinded Independent Central Review (BICR)
Time Frame: Approximately 5 years
|
The time from date of randomization to the first documented disease progression per RECIST v1.1 or to death due to any cause.
|
Approximately 5 years
|
|
Confirmed Objective Response Rate (ORR) per RECIST v1.1 as assessed by BICR
Time Frame: Approximately 5 years
|
The proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1.
|
Approximately 5 years
|
Collaborators and Investigators
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Respiratory Tract Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Diseases
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Organic Chemicals
- Hydrocarbons
- Cycloparaffins
- Hydrocarbons, Alicyclic
- Hydrocarbons, Cyclic
- Terpenes
- Taxoids
- Cyclodecanes
- Diterpenes
- Docetaxel
Other Study ID Numbers
- SGNB6A-002
- C5751002 (Other Identifier: Alias Study Number)
- 2023-503827-25-01 (Registry Identifier: CTIS (EU))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carcinoma, Non-Small-Cell Lung
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Bristol-Myers SquibbTerminatedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung Carcinoma | Non-Squamous Non-Small...United States
-
M.D. Anderson Cancer CenterCompletedStage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage II Lung Non-Small Cell Cancer AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7 | Stage I Lung Non-Small Cell Cancer AJCC v7 | Stage...United States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedStage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7 | Recurrent Lung Non-Small Cell Carcinoma | Stage IIIB Lung Non-Small Cell Cancer AJCC v7 | Stage IA...United States
-
National Cancer Institute (NCI)Active, not recruitingLung Non-Squamous Non-Small Cell Carcinoma | Stage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage II Lung Non-Small Cell Cancer AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7United States, Puerto Rico
-
National Cancer Institute (NCI)CompletedStage IIIA Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
Genelux CorporationNewsoara Biopharma Co., Ltd.RecruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Advanced Non-squamous Non-small-cell Lung Cancer | Non-small Cell Lung Cancer Stage IV | Metastatic Squamous Non-Small Cell Lung Carcinoma | Non-small Cell Lung Cancer Recurrent | Metastatic Non-squamous Non Small Cell Lung Cancer and other conditionsUnited States
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
PfizerRecruitingNon-small Cell Carcinoma | Non-Small Cell Lung Carcinoma | Non-Small Cell Lung Cancer MetastaticUnited States, United Kingdom, Canada, Taiwan, China, Belgium, Spain, Australia, France, Czechia, India, Slovakia, Japan, Finland, Greece, Denmark, Puerto Rico, Germany, Netherlands, Bulgaria, Italy, Sweden, Mexico, South Korea, Israel, A... and more
-
National Cancer Institute (NCI)CompletedStage IIIA Lung Non-Small Cell Cancer AJCC v7 | Advanced Lung Non-Squamous Non-Small Cell Carcinoma | Metastatic Lung Non-Squamous Non-Small Cell Carcinoma | Stage IIIB Lung Non-Small Cell Cancer AJCC v7 | Stage IV Lung Non-Small Cell Cancer AJCC v7 | Stage III Lung Non-Small Cell Cancer AJCC...United States
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
Clinical Trials on docetaxel
-
Nereus Pharmaceuticals, Inc.CompletedCancerUnited States, Australia, India, Chile, Brazil, Argentina
-
Tianjin Medical University Cancer Institute and...Recruiting
-
National Cancer Center, KoreaSeoul National University Bundang Hospital; Gachon University Gil Medical Center and other collaboratorsUnknownGastric CancerKorea, Republic of
-
Instituto do Cancer do Estado de São PauloNot yet recruitingProstate Cancer (Adenocarcinoma)Brazil
-
AkesoRecruitingNon-Small Cell Lung CancerChina
-
Optimal Health ResearchCompletedBreast Cancer | Lung Cancer | Prostate CancerUnited States
-
Zhuhai Beihai Biotech Co., LtdCompletedSolid Tumours | Bioequivalence | DocetaxelIndia
-
Jiangsu HengRui Medicine Co., Ltd.Shanghai Pulmonary Hospital, Shanghai, ChinaCompletedNon-Small Cell Lung Cancer (NSCLC)China
-
Arog Pharmaceuticals, Inc.WithdrawnCarcinoma, Non-Small-Cell Lung
-
Guangdong Provincial People's HospitalShanghai Henlius BiotechActive, not recruitingGastric Cancer Stage IIIChina