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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04154956
Ethics application status
Date submitted
5/11/2019
Date registered
7/11/2019
Date last updated
30/06/2020

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 Non- Squamous Non-Small Cell Lung Cancer Patients With CEACAM5 Positive Tumors
Secondary ID [1] 0 0
2019-001273-81
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 - 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) - PFS will be defined as the time from randomization to the date of the first documented disease progression or death of any cause, whichever comes first.
Timepoint [1] 0 0
Baseline to up to approximately 15 months
Primary outcome [2] 0 0
Overall Survival (OS) - OS will be defined as the time of randomization to the date of death due to any cause.
Timepoint [2] 0 0
Baseline up to approximately 2 years
Secondary outcome [1] 0 0
Objective response rate (ORR) - Objective response rate will be defined as the proportion of participants who have a complete response (CR) or partial response (PR), as best overall response derived from Overall Response (OR) determined by the Independent Radiology Review Committee (IRC) per Response Evaluation Criteria in Solid Tumor (RECIST) 1.1.
Timepoint [1] 0 0
Baseline up to approximately 2 years
Secondary outcome [2] 0 0
Health related quality of life (HRQOL) - disease related symptoms - Time to deterioration (TTD) in disease related symptoms as determined by European Organization for Research and Treatment for Cancer (EORTC)- Quality of life Questionnaire (QLQ)-Lung Cancer (LC)13.
Timepoint [2] 0 0
Baseline up to median 12 months
Secondary outcome [3] 0 0
Health related quality of life (HRQOL) - physical function - TTD in physical function as determined by EORTC-QLQ-C30.
Timepoint [3] 0 0
Baseline up to median 12 months
Secondary outcome [4] 0 0
Health related quality of life (HRQOL) - role function - TTD in role function as determined by EORTC-QLQ-C30.
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) - Incidence of TEAEs and SAEs and laboratory abnormalities according to National Cancer Institute Common Terminology Criteria for Adverse. Events (NCI CTCAE) V5.
Timepoint [5] 0 0
Baseline up to end of study (approximately 2 years)
Secondary outcome [6] 0 0
Duration of response (DOR) - Duration of response (DOR) is defined as the time from first documented evidence of complete response (CR) or partial response (PR) until progressive disease (PD) determined per RECIST 1.1 or death from any cause, whichever occurs first.
Timepoint [6] 0 0
Baseline up to approximately 2 years

Eligibility
Key inclusion 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 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 effective contraceptive methods during and for
at least 7 months after the last dose of study intervention.

- A male participant who agrees to use 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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 within 4 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 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
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
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Argentina
State/province [7] 0 0
Buenos Aires
Country [8] 0 0
Argentina
State/province [8] 0 0
Caba
Country [9] 0 0
Argentina
State/province [9] 0 0
Capital Federal
Country [10] 0 0
Argentina
State/province [10] 0 0
Rosario
Country [11] 0 0
Argentina
State/province [11] 0 0
Salta
Country [12] 0 0
Argentina
State/province [12] 0 0
Viedma
Country [13] 0 0
Belgium
State/province [13] 0 0
Brugge
Country [14] 0 0
Belgium
State/province [14] 0 0
Bruxelles
Country [15] 0 0
Belgium
State/province [15] 0 0
Leuven
Country [16] 0 0
Belgium
State/province [16] 0 0
Liège
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Burgas
Country [18] 0 0
Canada
State/province [18] 0 0
Greenfield Park
Country [19] 0 0
Canada
State/province [19] 0 0
Montreal
Country [20] 0 0
Chile
State/province [20] 0 0
Santiago
Country [21] 0 0
Chile
State/province [21] 0 0
Temuco
Country [22] 0 0
Chile
State/province [22] 0 0
Viña Del Mar
Country [23] 0 0
China
State/province [23] 0 0
Guangzhou
Country [24] 0 0
China
State/province [24] 0 0
Hangzhou
Country [25] 0 0
China
State/province [25] 0 0
Jinan
Country [26] 0 0
China
State/province [26] 0 0
Zhanjiang
Country [27] 0 0
France
State/province [27] 0 0
Saint-Mande
Country [28] 0 0
Hungary
State/province [28] 0 0
Budapest
Country [29] 0 0
Hungary
State/province [29] 0 0
Farkasgyepü
Country [30] 0 0
Japan
State/province [30] 0 0
Bunkyo-Ku
Country [31] 0 0
Japan
State/province [31] 0 0
Fukuoka-Shi
Country [32] 0 0
Japan
State/province [32] 0 0
Himeji-Shi
Country [33] 0 0
Japan
State/province [33] 0 0
Hirakata-Shi
Country [34] 0 0
Japan
State/province [34] 0 0
Kanazawa-Shi
Country [35] 0 0
Japan
State/province [35] 0 0
Kurume-Shi
Country [36] 0 0
Japan
State/province [36] 0 0
Nagoya-Shi
Country [37] 0 0
Japan
State/province [37] 0 0
Natori-Shi
Country [38] 0 0
Japan
State/province [38] 0 0
Osaka Sayama-Shi
Country [39] 0 0
Japan
State/province [39] 0 0
Osaka-Shi
Country [40] 0 0
Japan
State/province [40] 0 0
Sakai-Shi
Country [41] 0 0
Japan
State/province [41] 0 0
Sapporo-Shi
Country [42] 0 0
Japan
State/province [42] 0 0
Sunto-Gun
Country [43] 0 0
Japan
State/province [43] 0 0
Ube-Shi
Country [44] 0 0
Japan
State/province [44] 0 0
Wakayama-Shi
Country [45] 0 0
Japan
State/province [45] 0 0
Yokohama-Shi
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Seoul
Country [47] 0 0
Netherlands
State/province [47] 0 0
Utrecht
Country [48] 0 0
Poland
State/province [48] 0 0
Warsaw
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Moscow
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Saint -Petersburg
Country [51] 0 0
Spain
State/province [51] 0 0
Barcelona
Country [52] 0 0
Spain
State/province [52] 0 0
Hospitalet De Llobregat
Country [53] 0 0
Spain
State/province [53] 0 0
Madrid
Country [54] 0 0
Spain
State/province [54] 0 0
Pamplona
Country [55] 0 0
Turkey
State/province [55] 0 0
Adana
Country [56] 0 0
Turkey
State/province [56] 0 0
Ankara
Country [57] 0 0
Turkey
State/province [57] 0 0
Edirne
Country [58] 0 0
Turkey
State/province [58] 0 0
Istanbul
Country [59] 0 0
Turkey
State/province [59] 0 0
Izmir
Country [60] 0 0
Turkey
State/province [60] 0 0
Malatya

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 cutoff date for each given analysis (progressive free survival [PFS] and
overall survival [OS]).

Study success is defined either on PFS or OS

- The primary objective is to determine whether SAR408701 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 SAR408701 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 SAR408701 with docetaxel

- To compare the health related quality of life (HRQOL) of SAR408701 with docetaxel

- To evaluate the safety of SAR408701 compared to docetaxel

- To assess the duration of response (DOR) of SAR408701 with docetaxel
Trial website
https://clinicaltrials.gov/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
Trial Transparency email recommended (Toll free number for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
Contact-US@sanofi.com
Contact person for scientific queries

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