Clinical trial NCT04154956: 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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer Metastatic
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2019-11-07
Enrollment: 389
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: The median expected duration of study per participant was 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 agreed to use highly effective contraceptive methods during and for at least 7 months after the last dose of study intervention.
* A male participant who agreed to use highly effective contraception methods during and for at least 6 months after the last dose of study intervention.

Exclusion Criteria:

* Participants 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 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 was 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.
* Contraindicated the 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, contraindicated participation in the study.

The above information was not intended to contain all considerations relevant to a potential participation in a clinical trial.

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks
measure: Overall Survival (OS)
timeFrame: From date of first study treatment administration (Day 1) until the date of death due to any cause, up to 189 weeks
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks
measure: Time to Deterioration (TTD) in Disease-related Symptoms as Determined by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire and Lung Cancer-specific Module With 13 Items (EORTC QLQ LC-13)
timeFrame: Predose on Day 1 of Cycle 1, then on Day 1 of every 2 docetaxel Cycles, or every 3 tusamitamab ravtansine Cycles (i.e., every 6 weeks) up to 30 days after the last dose of study drug administration, up to 151 weeks
measure: TTD in Physical Function as Determined by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Cancer-specific Module With 30 Items (EORTC QLQ C30)
timeFrame: Predose on Day 1 of Cycle 1, then on Day 1 of every 2 docetaxel Cycles, or every 3 tusamitamab ravtansine Cycles (i.e., every 6 weeks) up to 30 days after the last dose of study drug administration, up to 151 weeks
measure: TTD in Role Function Measured by EORTC QLQ C30
timeFrame: Predose on Day 1 of Cycle 1, then on Day 1 of every 2 docetaxel Cycles, or every 3 tusamitamab ravtansine Cycles (i.e., every 6 weeks) up to 30 days after the last dose of study drug administration, up to 151 weeks
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration, up to 151 weeks
measure: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters
timeFrame: From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration, up to 151 weeks
measure: Number of Participants With PCSA in Clinical Chemistry
timeFrame: From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration, up to 151 weeks
measure: Duration of Response (DOR)
timeFrame: Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health Site Number : 8400033
state: Colorado
city: Fort Myers
country: United States
facility: Florida Cancer Specialists South Division Site Number : 8400020
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists North Division Site Number : 8400019
state: Florida
city: Grand Rapids
country: United States
facility: Ca & Hem Center Of W Michigan Site Number : 8400016
state: Michigan
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute Site Number : 8400011
state: New York
city: Wynnewood
country: United States
facility: Lankenau Hospital Cancer Center Site Number : 8400017
state: Pennsylvania
city: El Paso
country: United States
facility: Renovatio Clinical Site Number : 8400032
state: Texas
city: The Woodlands
country: United States
facility: Renovatio Clinical Site Number : 8400013
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Site Number : 8400006
state: Wisconsin
city: Caba
country: Argentina
facility: Investigational Site Number : 0320009
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Investigational Site Number : 0320012
state: Buenos Aires
city: Pergamino
country: Argentina
facility: Investigational Site Number : 0320008
state: Buenos Aires
city: Viedma
country: Argentina
facility: Investigational Site Number : 0320003
state: Río Negro
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320005
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320001
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320004
city: Ciudad De Cordoba
country: Argentina
facility: Investigational Site Number : 0320014
city: Salta
country: Argentina
facility: Investigational Site Number : 0320002
city: Blacktown
country: Australia
facility: Investigational Site Number : 0360002
state: New South Wales
city: Waratah
country: Australia
facility: Investigational Site Number : 0360003
state: New South Wales
city: Woolloongabba
country: Australia
facility: Investigational Site Number : 0360001
state: Queensland
city: Anderlecht
country: Belgium
facility: Investigational Site Number : 0560006
city: Charleroi
country: Belgium
facility: Investigational Site Number : 0560007
city: Edegem
country: Belgium
facility: Investigational Site Number : 0560004
city: Gent
country: Belgium
facility: Investigational Site Number : 0560005
city: Leuven
country: Belgium
facility: Investigational Site Number : 0560001
city: Liège
country: Belgium
facility: Investigational Site Number : 0560003
city: Sint-Lambrechts-Woluwe
country: Belgium
facility: Investigational Site Number : 0560002
city: Fortaleza
country: Brazil
facility: Centro Regional Integrado De Oncologia - CRIO Site Number : 0760002
state: Ceará
city: Curitiba
country: Brazil
facility: Instituto De Oncologia Parana Site Number : 0760008
state: Paraná
city: Natal
country: Brazil
facility: Centro Avancado de Oncologia CECAN - Liga Contra o Cancer Site Number : 0760026
state: Rio Grande Do Norte
city: Blumenau
country: Brazil
facility: Clínica de Oncologia Reichow Site Number : 0760023
state: Santa Catarina
city: Sao Jose do Rio Preto
country: Brazil
facility: Hospital de Base Sao Jose do Rio Preto Site Number : 0760001
state: São Paulo
city: Sao Paulo
country: Brazil
facility: IEP - Instituto de Ensino e Pesquisa Sao Lucas Site Number : 0760010
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Hospital Sirio Libanes Site Number : 0760018
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz Site Number : 0760022
state: São Paulo
city: Burgas
country: Bulgaria
facility: Investigational Site Number : 1000008
city: Pleven
country: Bulgaria
facility: Investigational Site Number : 1000010
city: Plovdiv
country: Bulgaria
facility: Investigational Site Number : 1000007
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000004
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000002
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000003
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000005
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000001
city: Halifax
country: Canada
facility: Investigational Site Number : 1240008
state: Nova Scotia
city: Greenfield Park
country: Canada
facility: Investigational Site Number : 1240003
state: Quebec
city: Montreal
country: Canada
facility: Investigational Site Number : 1240010
state: Quebec
city: Montreal
country: Canada
facility: Investigational Site Number : 1240009
state: Quebec
city: Santiago
country: Chile
facility: Investigational Site Number : 1520007
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520006
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520009
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520002
state: Reg Metropolitana De Santiago
city: Viña del Mar
country: Chile
facility: Investigational Site Number : 1520001
state: Valparaíso
city: Beijing
country: China
facility: Investigational Site Number : 1560026
city: Beijing
country: China
facility: Investigational Site Number : 1560042
city: Changchun
country: China
facility: Investigational Site Number : 1560009
city: Changchun
country: China
facility: Investigational Site Number : 1560010
city: Changsha
country: China
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city: Changsha
country: China
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city: Chengdu
country: China
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city: Chengdu
country: China
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city: Chongqing
country: China
facility: Investigational Site Number : 1560044
city: Chongqing
country: China
facility: Investigational Site Number : 1560043
city: Fuzhou
country: China
facility: Investigational Site Number : 1560024
city: Ganzhou
country: China
facility: Investigational Site Number : 1560051
city: Guangzhou
country: China
facility: Investigational Site Number : 1560001
city: Guangzhou
country: China
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city: Guangzhou
country: China
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city: Guangzhou
country: China
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city: Guangzhou
country: China
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city: Hangzhou
country: China
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city: Hangzhou
country: China
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city: Hangzhou
country: China
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city: Hangzhou
country: China
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city: Hangzhou
country: China
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city: Harbin
country: China
facility: Investigational Site Number : 1560005
city: Hefei
country: China
facility: Investigational Site Number : 1560014
city: Hefei
country: China
facility: Investigational Site Number : 1560004
city: Huizhou
country: China
facility: Investigational Site Number : 1560050
city: Jinan
country: China
facility: Investigational Site Number : 1560047
city: Nanchang
country: China
facility: Investigational Site Number : 1560035
city: Nanjing
country: China
facility: Investigational Site Number : 1560023
city: Nanjing
country: China
facility: Investigational Site Number : 1560019
city: Nanning
country: China
facility: Investigational Site Number : 1560012
city: Tianjin
country: China
facility: Investigational Site Number : 1560045
city: Wuhan
country: China
facility: Investigational Site Number : 1560006
city: Zhanjiang
country: China
facility: Investigational Site Number : 1560016
city: Zhengzhou
country: China
facility: Investigational Site Number : 1560041
city: Zhengzhou
country: China
facility: Investigational Site Number : 1560040
city: Zhongshan
country: China
facility: Investigational Site Number : 1560048
city: Bordeaux Cedex
country: France
facility: Investigational Site Number : 2500010
city: CAEN Cedex 05
country: France
facility: Investigational Site Number : 2500008
city: Creteil
country: France
facility: Investigational Site Number : 2500006
city: Dijon
country: France
facility: Investigational Site Number : 2500005
city: GRENOBLE Cedex 9
country: France
facility: Investigational Site Number : 2500007
city: Marseille
country: France
facility: Investigational Site Number : 2500001
city: Montpellier
country: France
facility: Investigational Site Number : 2500013
city: Paris
country: France
facility: Investigational Site Number : 2500011
city: Paris
country: France
facility: Investigational Site Number : 2500014
city: Pierre Benite
country: France
facility: Investigational Site Number : 2500009
city: RENNES Cedex 09
country: France
facility: Investigational Site Number : 2500003
city: Saint Herblain
country: France
facility: Investigational Site Number : 2500012
city: Saint-mande
country: France
facility: Investigational Site Number : 2500002
city: Villejuif
country: France
facility: Investigational Site Number : 2500004
city: Essen
country: Germany
facility: Investigational Site Number : 2760002
city: Heidelberg
country: Germany
facility: Investigational Site Number : 2760001
city: Athens
country: Greece
facility: Investigational Site Number : 3000005
city: Athens
country: Greece
facility: Investigational Site Number : 3000001
city: Heraklion
country: Greece
facility: Investigational Site Number : 3000003
city: Ioannina
country: Greece
facility: Investigational Site Number : 3000004
city: Larisa
country: Greece
facility: Investigational Site Number : 3000002
city: Thessaloniki
country: Greece
facility: Investigational Site Number : 3000006
city: Budapest
country: Hungary
facility: Investigational Site Number : 3480003
city: Budapest
country: Hungary
facility: Investigational Site Number : 3480004
city: Budapest
country: Hungary
facility: Investigational Site Number : 3480007
city: Kaposvár
country: Hungary
facility: Investigational Site Number : 3480005
city: Bhubaneswar
country: India
facility: Investigational Site Number : 3560010
city: Jaipur
country: India
facility: Investigational Site Number : 3560008
city: New Delhi
country: India
facility: Investigational Site Number : 3560007
city: Pune
country: India
facility: Investigational Site Number : 3560001
city: Pune
country: India
facility: Investigational Site Number : 3560006
city: Trivandrum
country: India
facility: Investigational Site Number : 3560011
city: Haifa
country: Israel
facility: Investigational Site Number : 3760001
city: Kfar-Saba
country: Israel
facility: Investigational Site Number : 3760002
city: Petach Tikva
country: Israel
facility: Investigational Site Number : 3760003
city: Ravenna
country: Italy
facility: Investigational Site Number : 3800004
state: Emilia-Romagna
city: Rozzano
country: Italy
facility: Investigational Site Number : 3800005
state: Milano
city: Orbassano
country: Italy
facility: Investigational Site Number : 3800003
state: Torino
city: Catania
country: Italy
facility: Investigational Site Number : 3800006
city: Milano
country: Italy
facility: Investigational Site Number : 3800001
city: Nagoya-shi
country: Japan
facility: Investigational Site Number : 3920002
state: Aichi
city: Nagoya-shi
country: Japan
facility: Investigational Site Number : 3920015
state: Aichi
city: Fukuoka-shi
country: Japan
facility: Investigational Site Number : 3920012
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Investigational Site Number : 3920008
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Investigational Site Number : 3920016
state: Hokkaido
city: Himeji-shi
country: Japan
facility: Investigational Site Number : 3920017
state: Hyogo
city: Kanazawa-shi
country: Japan
facility: Investigational Site Number : 3920006
state: Ishikawa
city: Yokohama-shi
country: Japan
facility: Investigational Site Number : 3920005
state: Kanagawa
city: Natori-shi
country: Japan
facility: Investigational Site Number : 3920009
state: Miyagi
city: Hirakata-shi
country: Japan
facility: Investigational Site Number : 3920001
state: Osaka
city: Osaka Sayama-shi
country: Japan
facility: Investigational Site Number : 3920013
state: Osaka
city: Osaka-shi
country: Japan
facility: Investigational Site Number : 3920003
state: Osaka
city: Sakai-shi
country: Japan
facility: Investigational Site Number : 3920014
state: Osaka
city: Sunto-gun
country: Japan
facility: Investigational Site Number : 3920004
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Investigational Site Number : 3920011
state: Tokyo
city: Mitaka-shi
country: Japan
facility: Investigational Site Number : 3920018
state: Tokyo
city: Wakayama-shi
country: Japan
facility: Investigational Site Number : 3920007
state: Wakayama
city: Ube-shi
country: Japan
facility: Investigational Site Number : 3920010
state: Yamaguchi
city: Busan
country: Korea, Republic of
facility: Investigational Site Number : 4100008
state: Busan-gwangyeoksi
city: Cheongju-si
country: Korea, Republic of
facility: Investigational Site Number : 4100005
state: Chungcheongbuk-do
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100006
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100007
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100003
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100004
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100001
city: Kaunas
country: Lithuania
facility: Investigational Site Number : 4400003
city: Vilnius
country: Lithuania
facility: Investigational Site Number : 4400001
city: Cuauhtémoc
country: Mexico
facility: Investigational Site Number : 4840003
state: Ciudad De Mexico
city: Ciudad de Mexico
country: Mexico
facility: Investigational Site Number : 4840009
city: 's Hertogenbosch
country: Netherlands
facility: Investigational Site Number : 5280003
city: Breda
country: Netherlands
facility: Investigational Site Number : 5280004
city: Utrecht
country: Netherlands
facility: Investigational Site Number : 5280005
city: Olsztyn
country: Poland
facility: Investigational Site Number : 6160004
state: Warminsko-mazurskie
city: Warsaw
country: Poland
facility: Investigational Site Number : 6160001
city: Almada
country: Portugal
facility: Investigational Site Number : 6200002
city: Lisboa
country: Portugal
facility: Investigational Site Number : 6200001
city: Lisboa
country: Portugal
facility: Investigational Site Number : 6200004
city: Porto
country: Portugal
facility: Investigational Site Number : 6200005
city: Porto
country: Portugal
facility: Investigational Site Number : 6200006
city: Alba Iulia
country: Romania
facility: Investigational Site Number : 6420008
city: Brasov
country: Romania
facility: Investigational Site Number : 6420009
city: Bucaresti
country: Romania
facility: Investigational Site Number : 6420003
city: Cluj-Napoca
country: Romania
facility: Investigational Site Number : 6420010
city: Cluj
country: Romania
facility: Investigational Site Number : 6420011
city: Craiova
country: Romania
facility: Investigational Site Number : 6420006
city: Otopeni
country: Romania
facility: Investigational Site Number : 6420012
city: Timisoara
country: Romania
facility: Investigational Site Number : 6420005
city: Timisoara
country: Romania
facility: Investigational Site Number : 6420004
city: Moscow
country: Russian Federation
facility: Investigational Site Number : 6430001
city: Saint -Petersburg
country: Russian Federation
facility: Investigational Site Number : 6430003
city: Singapore
country: Singapore
facility: Investigational Site Number : 7020001
city: Singapore
country: Singapore
facility: Investigational Site Number : 7020002
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240007
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240005
state: Barcelona [Barcelona]
city: Hospitalet de Llobregat
country: Spain
facility: Investigational Site Number : 7240001
state: Barcelona [Barcelona]
city: Madrid / Madrid
country: Spain
facility: Investigational Site Number : 7240009
state: Madrid, Comunidad De
city: Pamplona
country: Spain
facility: Investigational Site Number : 7240006
state: Navarra
city: Madrid
country: Spain
facility: Investigational Site Number : 7240002
city: Málaga
country: Spain
facility: Investigational Site Number : 7240004
city: Sevilla
country: Spain
facility: Investigational Site Number : 7240011
city: Valencia
country: Spain
facility: Investigational Site Number : 7240008
city: Adana
country: Turkey
facility: Investigational Site Number : 7920008
city: Adana
country: Turkey
facility: Investigational Site Number : 7920012
city: Adana
country: Turkey
facility: Investigational Site Number : 7920002
city: Ankara
country: Turkey
facility: Investigational Site Number : 7920011
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920005
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920001
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920006
city: Izmir
country: Turkey
facility: Investigational Site Number : 7920007
city: Izmir
country: Turkey
facility: Investigational Site Number : 7920010
city: Kocaeli
country: Turkey
facility: Investigational Site Number : 7920014
city: Malatya
country: Turkey
facility: Investigational Site Number : 7920009
city: Truro
country: United Kingdom
facility: Investigational Site Number : 8260004
state: Cornwall
city: London
country: United Kingdom
facility: Investigational Site Number : 8260002
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: