Spots Global Cancer Trial Database for SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients
Official Title: Randomized, Open-label, Phase 3 Study of SAR408701 Versus Docetaxel in Previously Treated, Metastatic Nonsquamous, Non-small-cell Lung Cancer Patients With CEACAM5-positive Tumors
Study ID: NCT04154956
Conditions
Study Description
Brief Summary: Primary Objectives: * Study is designed with two primary endpoints that will be analyzed on randomized participants at the time of the cut-off date for each given analysis (progression free survival \[PFS\] and overall survival \[OS\]) * Study success is defined either on PFS or OS * The primary objective is to determine whether tusamitamab ravtansine improves the progression free survival (PFS) when compared to docetaxel in participants with metastatic non-squamous non-small-cell lung cancer (NSCLC) expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor (ICI) * The primary objective is to determine whether tusamitamab ravtansine improves the overall survival (OS) when compared with docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor. Secondary Objectives: * To compare the objective response rate (ORR) of tusamitamab ravtansine with docetaxel * To compare the health-related quality of life (HRQOL) of tusamitamab ravtansine with docetaxel * To evaluate the safety of tusamitamab ravtansine compared to docetaxel * To assess the duration of response (DOR) of tusamitamab ravtansine as compared with docetaxel
Detailed Description: The expected duration of study intervention for participants who benefit from study intervention may vary, based on progression date; but median expected duration of study per participant is estimated as median 9 months in docetaxel arm (1 month for screening, 4 months for treatment, and 4 months for the EOT and follow-up visits) and 12.5 months in SAR408701 arm (1 month for screening, 6.5 months for treatment, and 5 months for end of treatment follow-up).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
National Jewish Health Site Number : 8400033, Denver, Colorado, United States
Florida Cancer Specialists South Division Site Number : 8400020, Fort Myers, Florida, United States
Florida Cancer Specialists North Division Site Number : 8400019, Saint Petersburg, Florida, United States
Ca & Hem Center Of W Michigan Site Number : 8400016, Grand Rapids, Michigan, United States
Roswell Park Cancer Institute Site Number : 8400011, Buffalo, New York, United States
Lankenau Hospital Cancer Center Site Number : 8400017, Wynnewood, Pennsylvania, United States
Thompson Cancer Survival Center Site Number : 8400038, Knoxville, Tennessee, United States
Tennessee Oncology Nashville Site Number : 8400003, Nashville, Tennessee, United States
Renovatio Clinical Site Number : 8400032, El Paso, Texas, United States
Renovatio Clinical Site Number : 8400013, The Woodlands, Texas, United States
Bon Secours St. Francis Medical Center Site Number : 8400035, Midlothian, Virginia, United States
Medical College of Wisconsin Site Number : 8400006, Milwaukee, Wisconsin, United States
Investigational Site Number : 0320009, Caba, Buenos Aires, Argentina
Investigational Site Number : 0320012, Capital Federal, Buenos Aires, Argentina
Investigational Site Number : 0320008, Pergamino, Buenos Aires, Argentina
Investigational Site Number : 0320003, Viedma, Río Negro, Argentina
Investigational Site Number : 0320005, Rosario, Santa Fe, Argentina
Investigational Site Number : 0320001, Buenos Aires, , Argentina
Investigational Site Number : 0320004, Buenos Aires, , Argentina
Investigational Site Number : 0320014, Ciudad De Cordoba, , Argentina
Investigational Site Number : 0320002, Salta, , Argentina
Investigational Site Number : 0360002, Blacktown, New South Wales, Australia
Investigational Site Number : 0360003, Waratah, New South Wales, Australia
Investigational Site Number : 0360001, Woolloongabba, Queensland, Australia
Investigational Site Number : 0560006, Anderlecht, , Belgium
Investigational Site Number : 0560007, Charleroi, , Belgium
Investigational Site Number : 0560004, Edegem, , Belgium
Investigational Site Number : 0560005, Gent, , Belgium
Investigational Site Number : 0560001, Leuven, , Belgium
Investigational Site Number : 0560003, Liège, , Belgium
Investigational Site Number : 0560002, Sint-Lambrechts-Woluwe, , Belgium
Centro Regional Integrado De Oncologia - CRIO Site Number : 0760002, Fortaleza, Ceará, Brazil
Instituto De Oncologia Parana Site Number : 0760008, Curitiba, Paraná, Brazil
Centro Avancado de Oncologia CECAN - Liga Contra o Cancer Site Number : 0760026, Natal, Rio Grande Do Norte, Brazil
Hospital Mae de Deus Site Number : 0760012, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital Sao Lucas da PUCRS Site Number : 0760005, Porto Alegre, Rio Grande Do Sul, Brazil
Clínica de Oncologia Reichow Site Number : 0760023, Blumenau, Santa Catarina, Brazil
Hospital de Base Sao Jose do Rio Preto Site Number : 0760001, Sao Jose do Rio Preto, São Paulo, Brazil
IEP - Instituto de Ensino e Pesquisa Sao Lucas Site Number : 0760010, Sao Paulo, São Paulo, Brazil
Hospital Sirio Libanes Site Number : 0760018, Sao Paulo, São Paulo, Brazil
A Beneficencia Portuguesa de Sao Paulo - Hospital Beneficencia Portuguesa - BP Mirante Site Number : 0760024, Sao Paulo, São Paulo, Brazil
Hospital Alemao Oswaldo Cruz Site Number : 0760022, Sao Paulo, São Paulo, Brazil
Nucleo de Pesquisa Clinica e Ensino da Rede Sao Camilo Site Number : 0760007, Sao Paulo, São Paulo, Brazil
OC ONCOCLINICAS BOTAFOGO Site Number : 0760025, Rio de Janeiro, , Brazil
Investigational Site Number : 1000008, Burgas, , Bulgaria
Investigational Site Number : 1000010, Pleven, , Bulgaria
Investigational Site Number : 1000007, Plovdiv, , Bulgaria
Investigational Site Number : 1000004, Sofia, , Bulgaria
Investigational Site Number : 1000002, Sofia, , Bulgaria
Investigational Site Number : 1000003, Sofia, , Bulgaria
Investigational Site Number : 1000005, Sofia, , Bulgaria
Investigational Site Number : 1000001, Sofia, , Bulgaria
Investigational Site Number : 1240008, Halifax, Nova Scotia, Canada
Investigational Site Number : 1240003, Greenfield Park, Quebec, Canada
Investigational Site Number : 1240010, Montreal, Quebec, Canada
Investigational Site Number : 1240009, Montreal, Quebec, Canada
Investigational Site Number : 1520005, Temuco, La Araucanía, Chile
Investigational Site Number : 1520007, Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520006, Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520004, Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520009, Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520002, Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520001, Viña del Mar, Valparaíso, Chile
Investigational Site Number : 1560026, Beijing, , China
Investigational Site Number : 1560029, Beijing, , China
Investigational Site Number : 1560027, Beijing, , China
Investigational Site Number : 1560030, Beijing, , China
Investigational Site Number : 1560042, Beijing, , China
Investigational Site Number : 1560009, Changchun, , China
Investigational Site Number : 1560010, Changchun, , China
Investigational Site Number : 1560015, Changsha, , China
Investigational Site Number : 1560039, Changsha, , China
Investigational Site Number : 1560032, Chengdu, , China
Investigational Site Number : 1560038, Chengdu, , China
Investigational Site Number : 1560044, Chongqing, , China
Investigational Site Number : 1560043, Chongqing, , China
Investigational Site Number : 1560024, Fuzhou, , China
Investigational Site Number : 1560051, Ganzhou, , China
Investigational Site Number : 1560001, Guangzhou, , China
Investigational Site Number : 1560036, Guangzhou, , China
Investigational Site Number : 1560037, Guangzhou, , China
Investigational Site Number : 1560017, Guangzhou, , China
Investigational Site Number : 1560034, Guangzhou, , China
Investigational Site Number : 1560025, Hangzhou, , China
Investigational Site Number : 1560033, Hangzhou, , China
Investigational Site Number : 1560021, Hangzhou, , China
Investigational Site Number : 1560018, Hangzhou, , China
Investigational Site Number : 1560011, Hangzhou, , China
Investigational Site Number : 1560005, Harbin, , China
Investigational Site Number : 1560014, Hefei, , China
Investigational Site Number : 1560004, Hefei, , China
Investigational Site Number : 1560050, Huizhou, , China
Investigational Site Number : 1560047, Jinan, , China
Investigational Site Number : 1560028, Jinan, , China
Investigational Site Number : 1560035, Nanchang, , China
Investigational Site Number : 1560023, Nanjing, , China
Investigational Site Number : 1560019, Nanjing, , China
Investigational Site Number : 1560012, Nanning, , China
Investigational Site Number : 1560045, Tianjin, , China
Investigational Site Number : 1560006, Wuhan, , China
Investigational Site Number : 1560016, Zhanjiang, , China
Investigational Site Number : 1560041, Zhengzhou, , China
Investigational Site Number : 1560040, Zhengzhou, , China
Investigational Site Number : 1560048, Zhongshan, , China
Investigational Site Number : 2500010, Bordeaux Cedex, , France
Investigational Site Number : 2500008, CAEN Cedex 05, , France
Investigational Site Number : 2500006, Creteil, , France
Investigational Site Number : 2500005, Dijon, , France
Investigational Site Number : 2500007, GRENOBLE Cedex 9, , France
Investigational Site Number : 2500001, Marseille, , France
Investigational Site Number : 2500013, Montpellier, , France
Investigational Site Number : 2500011, Paris, , France
Investigational Site Number : 2500014, Paris, , France
Investigational Site Number : 2500009, Pierre Benite, , France
Investigational Site Number : 2500003, RENNES Cedex 09, , France
Investigational Site Number : 2500012, Saint Herblain, , France
Investigational Site Number : 2500002, Saint-mande, , France
Investigational Site Number : 2500004, Villejuif, , France
Investigational Site Number : 2760002, Essen, , Germany
Investigational Site Number : 2760001, Heidelberg, , Germany
Investigational Site Number : 2760003, Oldenburg, , Germany
Investigational Site Number : 3000005, Athens, , Greece
Investigational Site Number : 3000001, Athens, , Greece
Investigational Site Number : 3000003, Heraklion, , Greece
Investigational Site Number : 3000004, Ioannina, , Greece
Investigational Site Number : 3000002, Larissa, , Greece
Investigational Site Number : 3000006, Thessaloniki, , Greece
Investigational Site Number : 3480003, Budapest, , Hungary
Investigational Site Number : 3480004, Budapest, , Hungary
Investigational Site Number : 3480007, Budapest, , Hungary
Investigational Site Number : 3480005, Kaposvár, , Hungary
Investigational Site Number : 3560010, Bhubaneswar, , India
Investigational Site Number : 3560008, Jaipur, , India
Investigational Site Number : 3560007, New Delhi, , India
Investigational Site Number : 3560001, Pune, , India
Investigational Site Number : 3560006, Pune, , India
Investigational Site Number : 3760001, Haifa, , Israel
Investigational Site Number : 3760002, Kfar-Saba, , Israel
Investigational Site Number : 3760003, Petach Tikva, , Israel
Investigational Site Number : 3800004, Ravenna, Emilia-Romagna, Italy
Investigational Site Number : 3800007, Aviano (PN), Friuli-Venezia Giulia, Italy
Investigational Site Number : 3800005, Rozzano, Milano, Italy
Investigational Site Number : 3800003, Orbassano, Torino, Italy
Investigational Site Number : 3800006, Catania, , Italy
Investigational Site Number : 3800001, Milano, , Italy
Investigational Site Number : 3920002, Nagoya-shi, Aichi, Japan
Investigational Site Number : 3920015, Nagoya-shi, Aichi, Japan
Investigational Site Number : 3920012, Fukuoka-shi, Fukuoka, Japan
Investigational Site Number : 3920008, Kurume-shi, Fukuoka, Japan
Investigational Site Number : 3920016, Sapporo-shi, Hokkaido, Japan
Investigational Site Number : 3920017, Himeji-shi, Hyogo, Japan
Investigational Site Number : 3920006, Kanazawa-shi, Ishikawa, Japan
Investigational Site Number : 3920005, Yokohama-shi, Kanagawa, Japan
Investigational Site Number : 3920009, Natori-shi, Miyagi, Japan
Investigational Site Number : 3920001, Hirakata-shi, Osaka, Japan
Investigational Site Number : 3920013, Osaka Sayama-shi, Osaka, Japan
Investigational Site Number : 3920003, Osaka-shi, Osaka, Japan
Investigational Site Number : 3920014, Sakai-shi, Osaka, Japan
Investigational Site Number : 3920004, Sunto-gun, Shizuoka, Japan
Investigational Site Number : 3920011, Bunkyo-ku, Tokyo, Japan
Investigational Site Number : 3920018, Mitaka-shi, Tokyo, Japan
Investigational Site Number : 3920007, Wakayama-shi, Wakayama, Japan
Investigational Site Number : 3920010, Ube-shi, Yamaguchi, Japan
Investigational Site Number : 4100008, Busan, Busan-gwangyeoksi, Korea, Republic of
Investigational Site Number : 4100005, Cheongju-si, Chungcheongbuk-do, Korea, Republic of
Investigational Site Number : 4100006, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100007, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100003, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100004, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100001, Seoul, , Korea, Republic of
Investigational Site Number : 4400003, Kaunas, , Lithuania
Investigational Site Number : 4400001, Vilnius, , Lithuania
Investigational Site Number : 4840003, Cuauhtémoc, Ciudad De Mexico, Mexico
Investigational Site Number : 4840004, Guadalajara, Jalisco, Mexico
Investigational Site Number : 4840008, San Luis Potosi, San Luis Potosí, Mexico
Investigational Site Number : 4840009, Ciudad de Mexico, , Mexico
Investigational Site Number : 5280003, 's Hertogenbosch, , Netherlands
Investigational Site Number : 5280004, Breda, , Netherlands
Investigational Site Number : 5280005, Utrecht, , Netherlands
Investigational Site Number : 6160004, Olsztyn, Warminsko-mazurskie, Poland
Investigational Site Number : 6160001, Warsaw, , Poland
Investigational Site Number : 6200002, Almada, , Portugal
Investigational Site Number : 6200001, Lisboa, , Portugal
Investigational Site Number : 6200004, Lisboa, , Portugal
Investigational Site Number : 6200005, Porto, , Portugal
Investigational Site Number : 6200006, Porto, , Portugal
Investigational Site Number : 6420008, Alba Iulia, , Romania
Investigational Site Number : 6420009, Brasov, , Romania
Investigational Site Number : 6420003, Bucaresti, , Romania
Investigational Site Number : 6420002, Bucuresti, , Romania
Investigational Site Number : 6420010, Cluj-Napoca, , Romania
Investigational Site Number : 6420011, Cluj, , Romania
Investigational Site Number : 6420006, Craiova, , Romania
Investigational Site Number : 6420012, Otopeni, , Romania
Investigational Site Number : 6420005, Timisoara, , Romania
Investigational Site Number : 6420004, Timisoara, , Romania
Investigational Site Number : 6430001, Moscow, , Russian Federation
Investigational Site Number : 6430003, Saint -Petersburg, , Russian Federation
Investigational Site Number : 7020001, Singapore, , Singapore
Investigational Site Number : 7020002, Singapore, , Singapore
Investigational Site Number : 7240007, Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240005, Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240001, Hospitalet de Llobregat, Barcelona [Barcelona], Spain
Investigational Site Number : 7240009, Madrid / Madrid, Madrid, Comunidad De, Spain
Investigational Site Number : 7240106, Madrid, Madrid, Comunidad De, Spain
Investigational Site Number : 7240010, Majadahonda, Madrid, Spain
Investigational Site Number : 7240006, Pamplona, Navarra, Spain
Investigational Site Number : 7240002, Madrid, , Spain
Investigational Site Number : 7240004, Málaga, , Spain
Investigational Site Number : 7240011, Sevilla, , Spain
Investigational Site Number : 7240008, Valencia, , Spain
Investigational Site Number : 7920008, Adana, , Turkey
Investigational Site Number : 7920012, Adana, , Turkey
Investigational Site Number : 7920002, Adana, , Turkey
Investigational Site Number : 7920011, Ankara, , Turkey
Investigational Site Number : 7920005, Istanbul, , Turkey
Investigational Site Number : 7920001, Istanbul, , Turkey
Investigational Site Number : 7920006, Istanbul, , Turkey
Investigational Site Number : 7920007, Izmir, , Turkey
Investigational Site Number : 7920010, Izmir, , Turkey
Investigational Site Number : 7920014, Kocaeli, , Turkey
Investigational Site Number : 7920009, Malatya, , Turkey
Investigational Site Number : 8260004, Truro, Cornwall, United Kingdom
Investigational Site Number : 8260002, London, , United Kingdom
Contact Details
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
