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SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small-cell Lung Cancer Patients
Sponsor: Sanofi
Summary
Primary Objectives: * Study was designed with multiple primary endpoints 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 was defined either on PFS or OS * The primary objective was 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 was 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: * Compared the objective response rate (ORR) of tusamitamab ravtansine with docetaxel * Compared the health-related quality of life (HRQOL) of tusamitamab ravtansine with docetaxel * Evaluated the safety of tusamitamab ravtansine compared to docetaxel * Assessed the duration of response (DOR) of tusamitamab ravtansine as compared with docetaxel
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
389
Start Date
2020-02-06
Completion Date
2026-03-31
Last Updated
2025-08-05
Healthy Volunteers
No
Conditions
Interventions
SAR408701
Pharmaceutical form: Concentrate for solution for intravenous infusion Route of administration: intravenous (IV) infusion
Docetaxel
Pharmaceutical form: Concentrate for solution for intravenous infusion Route of administration: IV infusion
Locations (169)
Florida Cancer Specialists South Division- Site Number : 8400020
Fort Myers, Florida, United States
Florida Cancer Specialists North Division- Site Number : 8400019
St. 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
Renovatio Clinical- Site Number : 8400032
El Paso, Texas, United States
Renovatio Clinical - Site Number : 8400013
The Woodlands, Texas, 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 : 0320003
Viedma, Río Negro Province, Argentina
Investigational Site Number : 0320001
Buenos Aires, Argentina
Investigational Site Number : 0320004
Buenos Aires, Argentina
Investigational Site Number : 0320014
Córdoba, 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 : 0560004
Edegem, Belgium
Investigational Site Number : 0560005
Ghent, Belgium
Investigational Site Number : 0560001
Leuven, Belgium
Investigational Site Number : 0560003
Liège, Belgium
Investigational Site Number : 0560002
Woluwe-Saint-Lambert, 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
Clínica de Oncologia Reichow Site Number : 0760023
Blumenau, Santa Catarina, Brazil
Hospital de Base Sao Jose do Rio Preto Site Number : 0760001
São José do Rio Preto, São Paulo, Brazil
Hospital Sirio Libanes- Site Number : 0760018
São Paulo, São Paulo, 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 : 1000003
Sofia, Bulgaria
Investigational Site Number : 1000001
Sofia, Bulgaria
Investigational Site Number : 1240003
Greenfield Park, Quebec, Canada
Investigational Site Number : 1240010
Montreal, Quebec, Canada
Investigational Site Number : 1520007
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520006
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, Región de Valparaíso, Chile
Investigational Site Number : 1560026
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 : 1560001
Guangzhou, China
Investigational Site Number : 1560036
Guangzhou, China
Investigational Site Number : 1560037
Guangzhou, China
Investigational Site Number : 1560017
Guangzhou, China
Investigational Site Number : 1560025
Hangzhou, China
Investigational Site Number : 1560033
Hangzhou, China
Investigational Site Number : 1560021
Hangzhou, China
Investigational Site Number : 1560011
Hangzhou, China
Investigational Site Number : 1560005
Harbin, China
Investigational Site Number : 1560050
Huizhou, China
Investigational Site Number : 1560047
Jinan, 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 : 2500010
Bordeaux, France
Investigational Site Number : 2500008
Caen, France
Investigational Site Number : 2500006
Créteil, France
Investigational Site Number : 2500007
Grenoble, 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-Bénite, France
Investigational Site Number : 2500003
Rennes, France
Investigational Site Number : 2500012
Saint-Herblain, France
Investigational Site Number : 2500002
Saint-Mandé, France
Investigational Site Number : 2500004
Villejuif, France
Investigational Site Number : 2760002
Essen, Germany
Investigational Site Number : 2760001
Heidelberg, 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 : 3000006
Thessaloniki, Greece
Investigational Site Number : 3480003
Budapest, Hungary
Investigational Site Number : 3480007
Budapest, Hungary
Investigational Site Number : 3480005
Kaposvár, Hungary
Investigational Site Number : 3760001
Haifa, Israel
Investigational Site Number : 3760002
Kfar Saba, Israel
Investigational Site Number : 3760003
Petah Tikva, Israel
Investigational Site Number : 3800004
Ravenna, Emilia-Romagna, 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
Milan, Italy
Investigational Site Number : 3920002
Nagoya, Aichi-ken, Japan
Investigational Site Number : 3920015
Nagoya, Aichi-ken, Japan
Investigational Site Number : 3920012
Fukuoka, Fukuoka, Japan
Investigational Site Number : 3920008
Kurume-shi, Fukuoka, Japan
Investigational Site Number : 3920016
Sapporo, Hokkaido, Japan
Investigational Site Number : 3920017
Himeji-shi, Hyōgo, Japan
Investigational Site Number : 3920006
Kanazawa, Ishikawa-ken, Japan
Investigational Site Number : 3920005
Yokohama, Kanagawa, Japan
Investigational Site Number : 3920009
Natori-shi, Miyagi, Japan
Investigational Site Number : 3920001
Hirakata-shi, Osaka, Japan
Investigational Site Number : 3920003
Osaka, Osaka, Japan
Investigational Site Number : 3920013
Osaka Sayama-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, Wakayama, Japan
Investigational Site Number : 3920010
Ube-shi, Yamaguchi, Japan
Investigational Site Number : 4840003
Cuauhtémoc, Mexico City, 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, Warmian-Masurian Voivodeship, Poland
Investigational Site Number : 6160001
Warsaw, Poland
Investigational Site Number : 6200002
Almada, Portugal
Investigational Site Number : 6200001
Lisbon, Portugal
Investigational Site Number : 6200004
Lisbon, 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 : 6420010
Cluj-Napoca, Romania
Investigational Site Number : 6420011
Cluj-Napoca, Romania
Investigational Site Number : 6420012
Otopeni, Romania
Investigational Site Number : 6420005
Timișoara, Romania
Investigational Site Number : 6430001
Moscow, Russia
Investigational Site Number : 6430003
Saint Petersburg, Russia
Investigational Site Number : 7020001
Singapore, Singapore
Investigational Site Number : 7020002
Singapore, Singapore
Investigational Site Number : 4100008
Busan, Busan, South Korea
Investigational Site Number : 4100005
Cheongju-si, North Chungcheong, South Korea
Investigational Site Number : 4100006
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100007
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100003
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100004
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 4100001
Seoul, South Korea
Investigational Site Number : 7240007
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240005
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240001
L'Hospitalet de Llobregat, Barcelona [Barcelona], Spain
Investigational Site Number : 7240009
Madrid / Madrid, Madrid, Comunidad de, Spain
Investigational Site Number : 7240006
Pamplona, Navarre, Spain
Investigational Site Number : 7240002
Madrid, Spain
Investigational Site Number : 7240004
Málaga, Spain
Investigational Site Number : 7240011
Seville, Spain
Investigational Site Number : 7240008
Valencia, Spain
Investigational Site Number : 7920008
Adana, Turkey (Türkiye)
Investigational Site Number : 7920012
Adana, Turkey (Türkiye)
Investigational Site Number : 7920002
Adana, Turkey (Türkiye)
Investigational Site Number : 7920011
Ankara, Turkey (Türkiye)
Investigational Site Number : 7920005
Istanbul, Turkey (Türkiye)
Investigational Site Number : 7920001
Istanbul, Turkey (Türkiye)
Investigational Site Number : 7920006
Istanbul, Turkey (Türkiye)
Investigational Site Number : 7920007
Izmir, Turkey (Türkiye)
Investigational Site Number : 7920010
Izmir, Turkey (Türkiye)
Investigational Site Number : 7920014
Kocaeli, Turkey (Türkiye)
Investigational Site Number : 7920009
Malatya, Turkey (Türkiye)