Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04154956




Registration number
NCT04154956
Ethics application status
Date submitted
5/11/2019
Date registered
7/11/2019
Date last updated
8/02/2024

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
U1111-1233-0781
Secondary ID [2] 0 0
EFC15858
Universal Trial Number (UTN)
Trial acronym
CARMEN-LC03
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer Metastatic 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SAR408701
Treatment: Drugs - Docetaxel

Experimental: SAR408701 (tusamitamab ravtansine) - Administered intravenously once every 2 weeks

Active Comparator: Docetaxel - Administered intravenously once every 3 weeks


Treatment: Drugs: SAR408701
Pharmaceutical form: Concentrate for solution for intravenous infusion Route of administration: intravenous (IV) infusion

Treatment: Drugs: Docetaxel
Pharmaceutical form: Concentrate for solution for intravenous infusion Route of administration: IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression free survival (PFS)
Timepoint [1] 0 0
Baseline to up to approximately 15 months
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Baseline up to approximately 2 years
Secondary outcome [1] 0 0
Objective response rate (ORR)
Timepoint [1] 0 0
Baseline up to approximately 2 years
Secondary outcome [2] 0 0
Health related quality of life (HRQOL) - disease related symptoms
Timepoint [2] 0 0
Baseline up to median 12 months
Secondary outcome [3] 0 0
Health related quality of life (HRQOL) - physical function
Timepoint [3] 0 0
Baseline up to median 12 months
Secondary outcome [4] 0 0
Health related quality of life (HRQOL) - role function
Timepoint [4] 0 0
Baseline up to median 12 months
Secondary outcome [5] 0 0
Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Timepoint [5] 0 0
Baseline up to end of study (approximately 2 years)
Secondary outcome [6] 0 0
Duration of response (DOR)
Timepoint [6] 0 0
Baseline up to approximately 2 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/08/2026
Actual
Sample size
Target
Accrual to date
Final
411
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Investigational Site Number : 0360002 - Blacktown
Recruitment hospital [2] 0 0
Investigational Site Number : 0360003 - Waratah
Recruitment hospital [3] 0 0
Investigational Site Number : 0360001 - Woolloongabba
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
United States of America
State/province [9] 0 0
Wisconsin
Country [10] 0 0
Argentina
State/province [10] 0 0
Buenos Aires
Country [11] 0 0
Argentina
State/province [11] 0 0
Río Negro
Country [12] 0 0
Argentina
State/province [12] 0 0
Santa Fe
Country [13] 0 0
Argentina
State/province [13] 0 0
Ciudad De Cordoba
Country [14] 0 0
Argentina
State/province [14] 0 0
Salta
Country [15] 0 0
Belgium
State/province [15] 0 0
Anderlecht
Country [16] 0 0
Belgium
State/province [16] 0 0
Charleroi
Country [17] 0 0
Belgium
State/province [17] 0 0
Edegem
Country [18] 0 0
Belgium
State/province [18] 0 0
Gent
Country [19] 0 0
Belgium
State/province [19] 0 0
Leuven
Country [20] 0 0
Belgium
State/province [20] 0 0
Liège
Country [21] 0 0
Belgium
State/province [21] 0 0
Sint-Lambrechts-Woluwe
Country [22] 0 0
Brazil
State/province [22] 0 0
Ceará
Country [23] 0 0
Brazil
State/province [23] 0 0
Paraná
Country [24] 0 0
Brazil
State/province [24] 0 0
Rio Grande Do Norte
Country [25] 0 0
Brazil
State/province [25] 0 0
Rio Grande Do Sul
Country [26] 0 0
Brazil
State/province [26] 0 0
Santa Catarina
Country [27] 0 0
Brazil
State/province [27] 0 0
São Paulo
Country [28] 0 0
Brazil
State/province [28] 0 0
Rio de Janeiro
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Burgas
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Pleven
Country [31] 0 0
Bulgaria
State/province [31] 0 0
Plovdiv
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Sofia
Country [33] 0 0
Canada
State/province [33] 0 0
Nova Scotia
Country [34] 0 0
Canada
State/province [34] 0 0
Quebec
Country [35] 0 0
Chile
State/province [35] 0 0
La Araucanía
Country [36] 0 0
Chile
State/province [36] 0 0
Reg Metropolitana De Santiago
Country [37] 0 0
Chile
State/province [37] 0 0
Valparaíso
Country [38] 0 0
China
State/province [38] 0 0
Beijing
Country [39] 0 0
China
State/province [39] 0 0
Changchun
Country [40] 0 0
China
State/province [40] 0 0
Changsha
Country [41] 0 0
China
State/province [41] 0 0
Chengdu
Country [42] 0 0
China
State/province [42] 0 0
Chongqing
Country [43] 0 0
China
State/province [43] 0 0
Fuzhou
Country [44] 0 0
China
State/province [44] 0 0
Ganzhou
Country [45] 0 0
China
State/province [45] 0 0
Guangzhou
Country [46] 0 0
China
State/province [46] 0 0
Hangzhou
Country [47] 0 0
China
State/province [47] 0 0
Harbin
Country [48] 0 0
China
State/province [48] 0 0
Hefei
Country [49] 0 0
China
State/province [49] 0 0
Huizhou
Country [50] 0 0
China
State/province [50] 0 0
Jinan
Country [51] 0 0
China
State/province [51] 0 0
Nanchang
Country [52] 0 0
China
State/province [52] 0 0
Nanjing
Country [53] 0 0
China
State/province [53] 0 0
Nanning
Country [54] 0 0
China
State/province [54] 0 0
Tianjin
Country [55] 0 0
China
State/province [55] 0 0
Wuhan
Country [56] 0 0
China
State/province [56] 0 0
Zhanjiang
Country [57] 0 0
China
State/province [57] 0 0
Zhengzhou
Country [58] 0 0
China
State/province [58] 0 0
Zhongshan
Country [59] 0 0
France
State/province [59] 0 0
Bordeaux Cedex
Country [60] 0 0
France
State/province [60] 0 0
CAEN Cedex 05
Country [61] 0 0
France
State/province [61] 0 0
Creteil
Country [62] 0 0
France
State/province [62] 0 0
Dijon
Country [63] 0 0
France
State/province [63] 0 0
GRENOBLE Cedex 9
Country [64] 0 0
France
State/province [64] 0 0
Marseille
Country [65] 0 0
France
State/province [65] 0 0
Montpellier
Country [66] 0 0
France
State/province [66] 0 0
Paris
Country [67] 0 0
France
State/province [67] 0 0
Pierre Benite
Country [68] 0 0
France
State/province [68] 0 0
RENNES Cedex 09
Country [69] 0 0
France
State/province [69] 0 0
Saint Herblain
Country [70] 0 0
France
State/province [70] 0 0
Saint-mande
Country [71] 0 0
France
State/province [71] 0 0
Villejuif
Country [72] 0 0
Germany
State/province [72] 0 0
Essen
Country [73] 0 0
Germany
State/province [73] 0 0
Heidelberg
Country [74] 0 0
Germany
State/province [74] 0 0
Oldenburg
Country [75] 0 0
Greece
State/province [75] 0 0
Athens
Country [76] 0 0
Greece
State/province [76] 0 0
Heraklion
Country [77] 0 0
Greece
State/province [77] 0 0
Ioannina
Country [78] 0 0
Greece
State/province [78] 0 0
Larissa
Country [79] 0 0
Greece
State/province [79] 0 0
Thessaloniki
Country [80] 0 0
Hungary
State/province [80] 0 0
Budapest
Country [81] 0 0
Hungary
State/province [81] 0 0
Kaposvár
Country [82] 0 0
India
State/province [82] 0 0
Bhubaneswar
Country [83] 0 0
India
State/province [83] 0 0
Jaipur
Country [84] 0 0
India
State/province [84] 0 0
New Delhi
Country [85] 0 0
India
State/province [85] 0 0
Pune
Country [86] 0 0
Israel
State/province [86] 0 0
Haifa
Country [87] 0 0
Israel
State/province [87] 0 0
Kfar-Saba
Country [88] 0 0
Israel
State/province [88] 0 0
Petach Tikva
Country [89] 0 0
Italy
State/province [89] 0 0
Emilia-Romagna
Country [90] 0 0
Italy
State/province [90] 0 0
Friuli-Venezia Giulia
Country [91] 0 0
Italy
State/province [91] 0 0
Milano
Country [92] 0 0
Italy
State/province [92] 0 0
Torino
Country [93] 0 0
Italy
State/province [93] 0 0
Catania
Country [94] 0 0
Japan
State/province [94] 0 0
Aichi
Country [95] 0 0
Japan
State/province [95] 0 0
Fukuoka
Country [96] 0 0
Japan
State/province [96] 0 0
Hokkaido
Country [97] 0 0
Japan
State/province [97] 0 0
Hyogo
Country [98] 0 0
Japan
State/province [98] 0 0
Ishikawa
Country [99] 0 0
Japan
State/province [99] 0 0
Kanagawa
Country [100] 0 0
Japan
State/province [100] 0 0
Miyagi
Country [101] 0 0
Japan
State/province [101] 0 0
Osaka
Country [102] 0 0
Japan
State/province [102] 0 0
Shizuoka
Country [103] 0 0
Japan
State/province [103] 0 0
Tokyo
Country [104] 0 0
Japan
State/province [104] 0 0
Wakayama
Country [105] 0 0
Japan
State/province [105] 0 0
Yamaguchi
Country [106] 0 0
Korea, Republic of
State/province [106] 0 0
Busan-gwangyeoksi
Country [107] 0 0
Korea, Republic of
State/province [107] 0 0
Chungcheongbuk-do
Country [108] 0 0
Korea, Republic of
State/province [108] 0 0
Seoul-teukbyeolsi
Country [109] 0 0
Korea, Republic of
State/province [109] 0 0
Seoul
Country [110] 0 0
Lithuania
State/province [110] 0 0
Kaunas
Country [111] 0 0
Lithuania
State/province [111] 0 0
Vilnius
Country [112] 0 0
Mexico
State/province [112] 0 0
Ciudad De Mexico
Country [113] 0 0
Mexico
State/province [113] 0 0
Jalisco
Country [114] 0 0
Mexico
State/province [114] 0 0
San Luis Potosí
Country [115] 0 0
Mexico
State/province [115] 0 0
Ciudad de Mexico
Country [116] 0 0
Netherlands
State/province [116] 0 0
's Hertogenbosch
Country [117] 0 0
Netherlands
State/province [117] 0 0
Breda
Country [118] 0 0
Netherlands
State/province [118] 0 0
Utrecht
Country [119] 0 0
Poland
State/province [119] 0 0
Warminsko-mazurskie
Country [120] 0 0
Poland
State/province [120] 0 0
Warsaw
Country [121] 0 0
Portugal
State/province [121] 0 0
Almada
Country [122] 0 0
Portugal
State/province [122] 0 0
Lisboa
Country [123] 0 0
Portugal
State/province [123] 0 0
Porto
Country [124] 0 0
Romania
State/province [124] 0 0
Alba Iulia
Country [125] 0 0
Romania
State/province [125] 0 0
Brasov
Country [126] 0 0
Romania
State/province [126] 0 0
Bucaresti
Country [127] 0 0
Romania
State/province [127] 0 0
Bucuresti
Country [128] 0 0
Romania
State/province [128] 0 0
Cluj-Napoca
Country [129] 0 0
Romania
State/province [129] 0 0
Cluj
Country [130] 0 0
Romania
State/province [130] 0 0
Craiova
Country [131] 0 0
Romania
State/province [131] 0 0
Otopeni
Country [132] 0 0
Romania
State/province [132] 0 0
Timisoara
Country [133] 0 0
Russian Federation
State/province [133] 0 0
Moscow
Country [134] 0 0
Russian Federation
State/province [134] 0 0
Saint -Petersburg
Country [135] 0 0
Singapore
State/province [135] 0 0
Singapore
Country [136] 0 0
Spain
State/province [136] 0 0
Barcelona [Barcelona]
Country [137] 0 0
Spain
State/province [137] 0 0
Madrid, Comunidad De
Country [138] 0 0
Spain
State/province [138] 0 0
Madrid
Country [139] 0 0
Spain
State/province [139] 0 0
Navarra
Country [140] 0 0
Spain
State/province [140] 0 0
Málaga
Country [141] 0 0
Spain
State/province [141] 0 0
Sevilla
Country [142] 0 0
Spain
State/province [142] 0 0
Valencia
Country [143] 0 0
Turkey
State/province [143] 0 0
Adana
Country [144] 0 0
Turkey
State/province [144] 0 0
Ankara
Country [145] 0 0
Turkey
State/province [145] 0 0
Istanbul
Country [146] 0 0
Turkey
State/province [146] 0 0
Izmir
Country [147] 0 0
Turkey
State/province [147] 0 0
Kocaeli
Country [148] 0 0
Turkey
State/province [148] 0 0
Malatya
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Cornwall
Country [150] 0 0
United Kingdom
State/province [150] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT04154956
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04154956