Lung Cancer Clinical Trial

SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small Cell Lung Cancer Patients

Summary

Primary Objectives:

Study is designed with two primary endpoints that will be analyzed on randomized participants at the time of the cutoff 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 NSCLC expressing CEACAM5 ≥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 ≥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 with docetaxel

View Full Description

Full 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 end of treatment 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).

View Eligibility Criteria

Eligibility Criteria

Inclusion criteria :

At least 18 years of age or above (or countries legal age of maturity if above 18 years) and signed the informed consent.
Histologically or cytologically proven diagnosis of non-squamous NSCLC with metastatic disease at study entry; progression after platinum-based chemotherapy and immune checkpoint inhibitor.
Participants with carcinoembryonic antigen-related cell adhesion molecule (CEACAM) 5 expression of ≥2+ in archival tumor sample (or if not available, fresh biopsy sample) involving at least 50 % of the tumor cell population as demonstrated prospectively by central laboratory via immune histochemistry (IHC).
At least one measurable lesion by RECIST v1.1 as determined by local site investigator /radiologist assessment.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
A female participant who agrees to use highly effective contraceptive methods during and for at least 7 months after the last dose of study intervention.
A male participant who agrees to use highly effective contraception methods during and for at least 6 months after the last dose of study intervention.

Exclusion criteria:

Patients with untreated brain metastases and history of leptomeningeal disease. if previously treated brain metastases no documentation of non-progressive disease in brain by imaging performed at least 4 weeks after CNS directed treatment and at least 2 weeks prior to the first dose of study intervention.
Significant concomitant illnesses, including all severe medical conditions that would impair the patient's participation in the study or interpretation of the results.
History within the last 3 years of an invasive malignancy other than the one treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.
Non-resolution of any prior treatment related toxicity to < grade 2 according to NCI CTCAE V5.0, except for alopecia, vitiligo and active thyroiditis controlled with hormonal replacement therapy
History of known acquired immunodeficiency syndrome (AIDS) related illnesses or known HIV disease requiring antiretroviral treatment, or unresolved viral hepatitis
Previous history of and/or unresolved corneal disorders. The use of contact lenses is not permitted.
Concurrent treatment with any other anticancer therapy.
Prior treatment with docetaxel or maytansinoid derivatives (DM1 or DM4 antibody drug conjugate) or any drug targeting CEACAM5.
Contraindication to use of corticosteroid premedication.
Previous enrollment in this study and current participation in any other clinical study involving an investigational study treatment or any other type of medical research.
Poor bone marrow, liver or kidney functions.
Hypersensitivity to any of the study interventions, or components thereof (EDTA), or drug (paclitaxel, polysorbate 80) or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

554

Study ID:

NCT04154956

Recruitment Status:

Recruiting

Sponsor:

Sanofi

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There are 203 Locations for this study

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Arizona Oncology Associates-Site Number:8400024
Tucson Arizona, 85704, United States
Comprehensive Blood and Cancer Center-Site Number:8400007
Bakersfield California, 93309, United States
Florida Cancer Specialists South Division-Site Number:8400020
Fort Myers Florida, 33901, United States
Florida Cancer Specialists North Division-Site Number:8400019
Saint Petersburg Florida, 33705, United States
Cancer Treatment Center of America(CTCA) - Southeastern-Site Number:8400015
Newnan Georgia, 30265, United States
Ca & Hem Center Of W Michigan-Site Number:8400016
Grand Rapids Michigan, 49546, United States
Lankenau Hospital Cancer Center-Site Number:8400017
Wynnewood Pennsylvania, 19096, United States
St. Francis Cancer Center-Site Number:8400014
Greenville South Carolina, 29607, United States
Tennessee Oncology Nashville-Site Number:8400003
Nashville Tennessee, 37203, United States
Texas Oncology, PA-Site Number:8400026
Austin Texas, 78745, United States
Texas Oncology, PA-Site Number:8400029
Beaumont Texas, 77702, United States
Texas Oncology, PA-Site Number:8400028
Dallas Texas, 75246, United States
Texas Oncology, PA-Site Number:8400030
El Paso Texas, 79902, United States
Renovatio Clinical-Site Number:8400032
El Paso Texas, 79915, United States
Texas Oncology, PA-Site Number:8400027
Fort Worth Texas, 76104, United States
Renovatio Clinical-Site Number:8400013
The Woodlands Texas, 77380, United States
Medical College of Wisconsin-Site Number:8400006
Milwaukee Wisconsin, 53226, United States
Investigational Site Number :0320009
Caba Buenos Aires, C1019, Argentina
Investigational Site Number :0320012
Capital Federal Buenos Aires, 1012, Argentina
Investigational Site Number :0320008
Pergamino Buenos Aires, B2700, Argentina
Investigational Site Number :0320003
Viedma Río Negro, R8500, Argentina
Investigational Site Number :0320005
Rosario Santa Fe, 2000, Argentina
Investigational Site Number :0320001
Buenos Aires , 1426A, Argentina
Investigational Site Number :0320004
Buenos Aires , C1125, Argentina
Investigational Site Number :0320014
Ciudad De Cordoba , ZCX50, Argentina
Investigational Site Number :0320002
Salta , 4400, Argentina
Investigational Site Number :0360002
Blacktown New South Wales, 2148, Australia
Investigational Site Number :0360003
Waratah New South Wales, 2298, Australia
Investigational Site Number :0360001
Woolloongabba Queensland, 4102, Australia
Investigational Site Number :0560005
Brugge , 8310, Belgium
Investigational Site Number :0560002
Bruxelles , 1200, Belgium
Investigational Site Number :0560004
Edegem , B-265, Belgium
Investigational Site Number :0560001
Leuven , 3000, Belgium
Investigational Site Number :0560003
Liège , 4000, Belgium
Investigational Site Number :0760002
Fortaleza Ceará, 60336, Brazil
Investigational Site Number :0760008
Curitiba Paraná, 80530, Brazil
Investigational Site Number :0760026
Nossa Senhora de Nazare Rio Grande Do Norte, 59062, Brazil
Investigational Site Number :0760012
Porto Alegre Rio Grande Do Sul, 90110, Brazil
Investigational Site Number :0760005
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Investigational Site Number :0760023
Blumenau Santa Catarina, 89010, Brazil
Investigational Site Number :0760001
Sao Jose do Rio Preto São Paulo, 15090, Brazil
Investigational Site Number :0760018
Sao Paulo São Paulo, 01308, Brazil
Investigational Site Number :0760024
Sao Paulo São Paulo, 01321, Brazil
Investigational Site Number :0760022
Sao Paulo São Paulo, 01327, Brazil
Investigational Site Number :0760007
Sao Paulo São Paulo, 04014, Brazil
Investigational Site Number :0760025
Rio de Janeiro , 22250, Brazil
Investigational Site Number :0760010
São Paulo , 01236, Brazil
Investigational Site Number :1000008
Burgas , 8000, Bulgaria
Investigational Site Number :1000010
Pleven , 5800, Bulgaria
Investigational Site Number :1000007
Plovdiv , 4002, Bulgaria
Investigational Site Number :1000004
Sofia , 1330, Bulgaria
Investigational Site Number :1000002
Sofia , 1407, Bulgaria
Investigational Site Number :1000003
Sofia , 1618, Bulgaria
Investigational Site Number :1000005
Sofia , 1756, Bulgaria
Investigational Site Number :1000001
Sofia , 1797, Bulgaria
Investigational Site Number :1240008
Halifax Nova Scotia, B3H 1, Canada
Investigational Site Number :1240003
Greenfield Park Quebec, J4V 2, Canada
Investigational Site Number :1240009
Montreal Quebec, H3T 1, Canada
Investigational Site Number :1520005
Temuco La Araucanía, 48105, Chile
Investigational Site Number :1520007
Santiago Reg Metropolitana De Santiago, 75007, Chile
Investigational Site Number :1520006
Santiago Reg Metropolitana De Santiago, 75009, Chile
Investigational Site Number :1520004
Santiago Reg Metropolitana De Santiago, 75100, Chile
Investigational Site Number :1520009
Santiago Reg Metropolitana De Santiago, 76505, Chile
Investigational Site Number :1520002
Santiago Reg Metropolitana De Santiago, 84203, Chile
Investigational Site Number :1520001
Viña del Mar Valparaíso, 25205, Chile
Investigational Site Number :1560026
Beijing , 10002, China
Investigational Site Number :1560029
Beijing , 10007, China
Investigational Site Number :1560027
Beijing , 10019, China
Investigational Site Number :1560030
Beijing , 10021, China
Investigational Site Number :1560042
Beijing , 10073, China
Investigational Site Number :1560009
Changchun , 13001, China
Investigational Site Number :1560010
Changchun , 13002, China
Investigational Site Number :1560015
Changsha , 41000, China
Investigational Site Number :1560039
Changsha , 41001, China
Investigational Site Number :1560032
Chengdu , 61004, China
Investigational Site Number :1560038
Chengdu , 61004, China
Investigational Site Number :1560044
Chongqing , 40003, China
Investigational Site Number :1560043
Chongqing , 40004, China
Investigational Site Number :1560024
Fuzhou , 35000, China
Investigational Site Number :1560051
Ganzhou , 34109, China
Investigational Site Number :1560001
Guangzhou , 51008, China
Investigational Site Number :1560036
Guangzhou , 51009, China
Investigational Site Number :1560037
Guangzhou , 51016, China
Investigational Site Number :1560017
Guangzhou , 51051, China
Investigational Site Number :1560034
Guangzhou , , China
Investigational Site Number :1560025
Hangzhou , 31000, China
Investigational Site Number :1560033
Hangzhou , 31000, China
Investigational Site Number :1560021
Hangzhou , 31001, China
Investigational Site Number :1560018
Hangzhou , 31001, China
Investigational Site Number :1560011
Hangzhou , 31002, China
Investigational Site Number :1560005
Harbin , 15008, China
Investigational Site Number :1560014
Hefei , 23000, China
Investigational Site Number :1560004
Hefei , 23002, China
Investigational Site Number :1560050
Huizhou , 51600, China
Investigational Site Number :1560047
Jinan , 25001, China
Investigational Site Number :1560028
Jinan , 25002, China
Investigational Site Number :1560035
Nanchang , 33000, China
Investigational Site Number :1560023
Nanjing , 21000, China
Investigational Site Number :1560019
Nanjing , 21000, China
Investigational Site Number :1560012
Nanning , 53002, China
Investigational Site Number :1560045
Tianjin , 30006, China
Investigational Site Number :1560006
Wuhan , 43007, China
Investigational Site Number :1560016
Zhanjiang , 52400, China
Investigational Site Number :1560041
Zhengzhou , 45000, China
Investigational Site Number :1560040
Zhengzhou , 45000, China
Investigational Site Number :1560048
Zhongshan , 52840, China
Investigational Site Number :2500010
Bordeaux Cedex , 33076, France
Investigational Site Number :2500008
CAEN Cedex 05 , 14076, France
Investigational Site Number :2500006
Creteil , 94010, France
Investigational Site Number :2500005
Dijon , 21079, France
Investigational Site Number :2500007
GRENOBLE Cedex 9 , 38043, France
Investigational Site Number :2500001
Marseille , 13015, France
Investigational Site Number :2500013
Montpellier , 34295, France
Investigational Site Number :2500012
Nantes , 44093, France
Investigational Site Number :2500014
Paris cedex 20 , 75970, France
Investigational Site Number :2500011
Paris , 75231, France
Investigational Site Number :2500009
Pierre Benite , 69495, France
Investigational Site Number :2500003
RENNES Cedex 09 , 35033, France
Investigational Site Number :2500002
Saint-mande , 94160, France
Investigational Site Number :2500004
Villejuif , 94800, France
Investigational Site Number :2760002
Essen , 45147, Germany
Investigational Site Number :2760001
Heidelberg , 69126, Germany
Investigational Site Number :2760003
Oldenburg , 26121, Germany
Investigational Site Number :3000005
Athens , 11526, Greece
Investigational Site Number :3000001
Athens , 11527, Greece
Investigational Site Number :3000003
Heraklion , 71110, Greece
Investigational Site Number :3000004
Ioannina , 455 0, Greece
Investigational Site Number :3000002
Larissa , 41110, Greece
Investigational Site Number :3000006
Thessaloniki , 54645, Greece
Investigational Site Number :3480003
Budapest , 1121, Hungary
Investigational Site Number :3480004
Budapest , 1122, Hungary
Investigational Site Number :3480007
Budapest , 1125, Hungary
Investigational Site Number :3480005
Kaposvár , 7400, Hungary
Investigational Site Number :3760001
Haifa , 31096, Israel
Investigational Site Number :3760002
Kfar-Saba , 44281, Israel
Investigational Site Number :3760003
Petach Tikva , 49100, Israel
Investigational Site Number :3800004
Ravenna Emilia-Romagna, 48121, Italy
Investigational Site Number :3800005
Rozzano Milano, 20089, Italy
Investigational Site Number :3800003
Orbassano Torino, 10043, Italy
Investigational Site Number :3800006
Catania , , Italy
Investigational Site Number :3800001
Milano , 20133, Italy
Investigational Site Number :3920002
Nagoya-shi Aichi, 460-0, Japan
Investigational Site Number :3920015
Nagoya-shi Aichi, 464-8, Japan
Investigational Site Number :3920012
Fukuoka-shi Fukuoka, 810-8, Japan
Investigational Site Number :3920008
Kurume-shi Fukuoka, 830-0, Japan
Investigational Site Number :3920016
Sapporo-shi Hokkaido, 003-0, Japan
Investigational Site Number :3920017
Himeji-shi Hyogo, 670-8, Japan
Investigational Site Number :3920006
Kanazawa-shi Ishikawa, 920-8, Japan
Investigational Site Number :3920005
Yokohama-shi Kanagawa, 241-8, Japan
Investigational Site Number :3920009
Natori-shi Miyagi, 981-1, Japan
Investigational Site Number :3920001
Hirakata-shi Osaka, 573-1, Japan
Investigational Site Number :3920013
Osaka Sayama-shi Osaka, 589-8, Japan
Investigational Site Number :3920003
Osaka-shi Osaka, 541-8, Japan
Investigational Site Number :3920014
Sakai-shi Osaka, 591-8, Japan
Investigational Site Number :3920004
Sunto-gun Shizuoka, 411-8, Japan
Investigational Site Number :3920011
Bunkyo-ku Tokyo, 113-8, Japan
Investigational Site Number :3920018
Mitaka-shi Tokyo, 181-8, Japan
Investigational Site Number :3920007
Wakayama-shi Wakayama, 641-8, Japan
Investigational Site Number :3920010
Ube-shi Yamaguchi, 755-0, Japan
Investigational Site Number :4100005
Cheongju-si Chungcheongbuk-do, 28644, Korea, Republic of
Investigational Site Number :4100006
Seoul Seoul-teukbyeolsi, 03722, Korea, Republic of
Investigational Site Number :4100007
Seoul Seoul-teukbyeolsi, 05505, Korea, Republic of
Investigational Site Number :4100003
Seoul Seoul-teukbyeolsi, 06351, Korea, Republic of
Investigational Site Number :4100004
Seoul Seoul-teukbyeolsi, 07061, Korea, Republic of
Investigational Site Number :4100008
Busan , 48108, Korea, Republic of
Investigational Site Number :4100001
Seoul , 06591, Korea, Republic of
Investigational Site Number :4840003
Cuauhtémoc Ciudad De Mexico, 06700, Mexico
Investigational Site Number :4840004
Guadalajara Jalisco, 44280, Mexico
Investigational Site Number :4840008
San Luis Potosi San Luis Potosí, 78250, Mexico
Investigational Site Number :4840002
Benito Juarez , 03100, Mexico
Investigational Site Number :5280003
's Hertogenbosch , 5223 , Netherlands
Investigational Site Number :5280004
Breda , 4818 , Netherlands
Investigational Site Number :5280005
Utrecht , 3543 , Netherlands
Investigational Site Number :6160004
Olsztyn Warminsko-mazurskie, 10-35, Poland
Investigational Site Number :6160001
Warsaw , 02-78, Poland
Investigational Site Number :6200002
Almada , 2801-, Portugal
Investigational Site Number :6200001
Lisboa , 1769, Portugal
Investigational Site Number :6200004
Lisboa , 1998-, Portugal
Investigational Site Number :6200005
Porto , 4099-, Portugal
Investigational Site Number :6200006
Porto , 4100-, Portugal
Investigational Site Number :6420008
Alba Iulia , 51007, Romania
Investigational Site Number :6420009
Brasov , 50015, Romania
Investigational Site Number :6420003
Bucharest , 02232, Romania
Investigational Site Number :6420002
Bucuresti , 10991, Romania
Investigational Site Number :6420010
Cluj-Napoca , 40012, Romania
Investigational Site Number :6420011
Cluj , 40728, Romania
Investigational Site Number :6420006
Craiova , 20034, Romania
Investigational Site Number :6420012
Otopeni , 75100, Romania
Investigational Site Number :6420005
Timisoara , 30016, Romania
Investigational Site Number :6420004
Timisoara , 30023, Romania
Investigational Site Number :6430001
Moscow , 11547, Russian Federation
Investigational Site Number :6430005
Omsk , 64401, Russian Federation
Investigational Site Number :6430003
Saint -Petersburg , 19775, Russian Federation
Investigational Site Number :6430004
St. Petersburg , 19002, Russian Federation
Investigational Site Number :7240007
Barcelona Barcelona [Barcelona], 08028, Spain
Investigational Site Number :7240005
Barcelona Barcelona [Barcelona], 08036, Spain
Investigational Site Number :7240001
Hospitalet de Llobregat Barcelona [Barcelona], 08908, Spain
Investigational Site Number :7240009
Madrid Comunidad De Madrid, 28040, Spain
Investigational Site Number :7240106
Madrid Madrid, Comunidad De, 28027, Spain
Investigational Site Number :7240002
Madrid Madrid, Comunidad De, 28041, Spain
Investigational Site Number :7240010
Majadahonda Madrid, 28222, Spain
Investigational Site Number :7240006
Pamplona Navarra, 31008, Spain
Investigational Site Number :7240004
Málaga , 29010, Spain
Investigational Site Number :7240011
Sevilla , 41013, Spain
Investigational Site Number :7240008
Valencia , 46026, Spain
Investigational Site Number :7920008
Adana , 01060, Turkey
Investigational Site Number :7920002
Adana , 01250, Turkey
Investigational Site Number :7920011
Ankara , 1111, Turkey
Investigational Site Number :7920005
Istanbul , 34214, Turkey
Investigational Site Number :7920001
Istanbul , 34303, Turkey
Investigational Site Number :7920006
Istanbul , 34722, Turkey
Investigational Site Number :7920007
Izmir , , Turkey
Investigational Site Number :7920010
Izmir , , Turkey
Investigational Site Number :7920009
Malatya , , Turkey

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

554

Study ID:

NCT04154956

Recruitment Status:

Recruiting

Sponsor:


Sanofi

How clear is this clinincal trial information?

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