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
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 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).
Eligibility Criteria
Inclusion Criteria:
At least 18 years of age or above (or country's 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 greater than or equal to 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 less than grade 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (V) 5.0, 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 potential participation in a clinical trial.
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There are 202 Locations for this study
Tucson Arizona, 85704, United States
Bakersfield California, 93309, United States
Fort Myers Florida, 33901, United States
Saint Petersburg Florida, 33705, United States
Newnan Georgia, 30265, United States
Grand Rapids Michigan, 49546, United States
Wynnewood Pennsylvania, 19096, United States
Nashville Tennessee, 37203, United States
Austin Texas, 78745, United States
Beaumont Texas, 77702, United States
Dallas Texas, 75246, United States
El Paso Texas, 79902, United States
El Paso Texas, 79915, United States
Fort Worth Texas, 76104, United States
The Woodlands Texas, 77380, United States
Milwaukee Wisconsin, 53226, United States
Caba Buenos Aires, C1019, Argentina
Capital Federal Buenos Aires, 1012, Argentina
Pergamino Buenos Aires, B2700, Argentina
Viedma Río Negro, R8500, Argentina
Rosario Santa Fe, 2000, Argentina
Buenos Aires , 1426A, Argentina
Buenos Aires , C1125, Argentina
Ciudad De Cordoba , ZCX50, Argentina
Salta , 4400, Argentina
Blacktown New South Wales, 2148, Australia
Waratah New South Wales, 2298, Australia
Woolloongabba Queensland, 4102, Australia
Bruxelles , 1200, Belgium
Edegem , B-265, Belgium
Gent , 9000, Belgium
Leuven , 3000, Belgium
Liège , 4000, Belgium
Fortaleza Ceará, 60336, Brazil
Curitiba Paraná, 80530, Brazil
Natal Rio Grande Do Norte, 59062, Brazil
Porto Alegre Rio Grande Do Sul, 90110, Brazil
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Blumenau Santa Catarina, 89010, Brazil
Sao Jose do Rio Preto São Paulo, 15090, Brazil
Sao Paulo São Paulo, 01308, Brazil
Sao Paulo São Paulo, 01321, Brazil
Sao Paulo São Paulo, 01327, Brazil
Sao Paulo São Paulo, 04014, Brazil
Rio de Janeiro , 22250, Brazil
São Paulo , 01236, Brazil
Burgas , 8000, Bulgaria
Pleven , 5800, Bulgaria
Plovdiv , 4002, Bulgaria
Sofia , 1330, Bulgaria
Sofia , 1407, Bulgaria
Sofia , 1618, Bulgaria
Sofia , 1756, Bulgaria
Sofia , 1797, Bulgaria
Halifax Nova Scotia, B3H 1, Canada
Greenfield Park Quebec, J4V 2, Canada
Montreal Quebec, H1T 1, Canada
Montreal Quebec, H3T 1, Canada
Temuco La Araucanía, 48105, Chile
Santiago Reg Metropolitana De Santiago, 75007, Chile
Santiago Reg Metropolitana De Santiago, 75009, Chile
Santiago Reg Metropolitana De Santiago, 75100, Chile
Santiago Reg Metropolitana De Santiago, 76505, Chile
Santiago Reg Metropolitana De Santiago, 84203, Chile
Viña del Mar Valparaíso, 25205, Chile
Beijing , 10002, China
Beijing , 10007, China
Beijing , 10019, China
Beijing , 10021, China
Beijing , 10073, China
Changchun , 13001, China
Changchun , 13002, China
Changsha , 41000, China
Changsha , 41001, China
Chengdu , 61004, China
Chengdu , 61004, China
Chongqing , 40003, China
Chongqing , 40004, China
Fuzhou , 35000, China
Ganzhou , 34109, China
Guangzhou , 51008, China
Guangzhou , 51009, China
Guangzhou , 51016, China
Guangzhou , 51051, China
Guangzhou , , China
Hangzhou , 31000, China
Hangzhou , 31000, China
Hangzhou , 31001, China
Hangzhou , 31001, China
Hangzhou , 31002, China
Harbin , 15008, China
Hefei , 23000, China
Hefei , 23002, China
Huizhou , 51600, China
Jinan , 25001, China
Jinan , 25002, China
Nanchang , 33000, China
Nanjing , 21000, China
Nanjing , 21000, China
Nanning , 53002, China
Tianjin , 30006, China
Wuhan , 43007, China
Zhanjiang , 52400, China
Zhengzhou , 45000, China
Zhengzhou , 45000, China
Zhongshan , 52840, China
Bordeaux Cedex , 33076, France
CAEN Cedex 05 , 14076, France
Creteil , 94010, France
Dijon , 21079, France
GRENOBLE Cedex 9 , 38043, France
Marseille , 13015, France
Montpellier , 34295, France
Nantes , 44093, France
Paris cedex 20 , 75970, France
Paris , 75231, France
Pierre Benite , 69495, France
RENNES Cedex 09 , 35033, France
Saint-mande , 94160, France
Villejuif , 94800, France
Essen , 45147, Germany
Heidelberg , 69126, Germany
Oldenburg , 26121, Germany
Athens , 11526, Greece
Athens , 11527, Greece
Heraklion , 71110, Greece
Ioannina , 455 0, Greece
Larissa , 41110, Greece
Thessaloniki , 54645, Greece
Budapest , 1121, Hungary
Budapest , 1122, Hungary
Budapest , 1125, Hungary
Kaposvár , 7400, Hungary
Haifa , 31096, Israel
Kfar-Saba , 44281, Israel
Petach Tikva , 49100, Israel
Ravenna Emilia-Romagna, 48121, Italy
Rozzano Milano, 20089, Italy
Orbassano Torino, 10043, Italy
Catania , , Italy
Milano , 20133, Italy
Nagoya-shi Aichi, 460-0, Japan
Nagoya-shi Aichi, 464-8, Japan
Fukuoka-shi Fukuoka, 810-8, Japan
Kurume-shi Fukuoka, 830-0, Japan
Sapporo-shi Hokkaido, 003-0, Japan
Himeji-shi Hyogo, 670-8, Japan
Kanazawa-shi Ishikawa, 920-8, Japan
Yokohama-shi Kanagawa, 241-8, Japan
Natori-shi Miyagi, 981-1, Japan
Hirakata-shi Osaka, 573-1, Japan
Osaka Sayama-shi Osaka, 589-8, Japan
Osaka-shi Osaka, 541-8, Japan
Sakai-shi Osaka, 591-8, Japan
Sunto-gun Shizuoka, 411-8, Japan
Bunkyo-ku Tokyo, 113-8, Japan
Mitaka-shi Tokyo, 181-8, Japan
Wakayama-shi Wakayama, 641-8, Japan
Ube-shi Yamaguchi, 755-0, Japan
Cheongju-si Chungcheongbuk-do, 28644, Korea, Republic of
Seoul Seoul-teukbyeolsi, 03722, Korea, Republic of
Seoul Seoul-teukbyeolsi, 05505, Korea, Republic of
Seoul Seoul-teukbyeolsi, 06351, Korea, Republic of
Seoul Seoul-teukbyeolsi, 07061, Korea, Republic of
Busan-gwangyeoksi , 48108, Korea, Republic of
Seoul , 06591, Korea, Republic of
Cuauhtémoc Ciudad De Mexico, 06700, Mexico
Guadalajara Jalisco, 44280, Mexico
San Luis Potosi San Luis Potosí, 78250, Mexico
Benito Juarez , 03100, Mexico
's Hertogenbosch , 5223 , Netherlands
Breda , 4818 , Netherlands
Utrecht , 3543 , Netherlands
Olsztyn Warminsko-mazurskie, 10-35, Poland
Warsaw , 02-78, Poland
Almada , 2801-, Portugal
Lisboa , 1769, Portugal
Lisboa , 1998-, Portugal
Porto , 4099-, Portugal
Porto , 4100-, Portugal
Alba Iulia , 51007, Romania
Brasov , 50015, Romania
Bucaresti , 02232, Romania
Bucuresti , 10991, Romania
Cluj-Napoca , 40012, Romania
Cluj , 40728, Romania
Craiova , 20034, Romania
Otopeni , 75100, Romania
Timisoara , 30016, Romania
Timisoara , 30023, Romania
Moscow , 11547, Russian Federation
Omsk , 64401, Russian Federation
Saint -Petersburg , 19775, Russian Federation
Barcelona Barcelona [Barcelona], 08028, Spain
Barcelona Barcelona [Barcelona], 08036, Spain
Hospitalet de Llobregat Barcelona [Barcelona], 08908, Spain
Madrid / Madrid Madrid, Comunidad De, 28040, Spain
Madrid Madrid, Comunidad De, 28027, Spain
Madrid Madrid, Comunidad De, 28041, Spain
Majadahonda Madrid, 28222, Spain
Pamplona Navarra, 31008, Spain
Málaga , 29010, Spain
Sevilla , 41013, Spain
Valencia , 46026, Spain
Adana , 01060, Turkey
Adana , 01250, Turkey
Ankara , 1111, Turkey
Istanbul , 34214, Turkey
Istanbul , 34303, Turkey
Istanbul , 34722, Turkey
Izmir , , Turkey
Izmir , , Turkey
Malatya , , Turkey
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