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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04154956
Ethics application status
Date submitted
5/11/2019
Date registered
7/11/2019

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) - Participants received tusamitamab ravtansine 100 milligrams per square meter (mg/m\^2) by intravenous (IV) infusion, once every 2 weeks (Q2W) until objective progressive disease (PD), unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 147 weeks).

Active comparator: Docetaxel - Participants received docetaxel 75 mg/m\^2 by IV infusion, once every 3 weeks (Q3W) until objective PD, unacceptable adverse event/toxicity, upon participant's request to stop treatment, or Investigator decision, whichever occurred first (maximum exposure: 115 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
Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
From date of first study treatment administration (Day 1) until the date of death due to any cause, up to 189 weeks
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks
Secondary outcome [2] 0 0
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)
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
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)
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
TTD in Role Function Measured by EORTC QLQ C30
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) in Hematology Parameters
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
Number of Participants With PCSA in Clinical Chemistry
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
Duration of Response (DOR)
Timepoint [8] 0 0
Tumor assessments performed at screening, and every 8 weeks +/-5 days thereafter, up to 189 weeks

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

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
30/06/2025
Actual
Sample size
Target
Accrual to date
Final
389
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
Texas
Country [7] 0 0
United States of America
State/province [7] 0 0
Wisconsin
Country [8] 0 0
Argentina
State/province [8] 0 0
Buenos Aires
Country [9] 0 0
Argentina
State/province [9] 0 0
Río Negro
Country [10] 0 0
Argentina
State/province [10] 0 0
Santa Fe
Country [11] 0 0
Argentina
State/province [11] 0 0
Ciudad De Cordoba
Country [12] 0 0
Argentina
State/province [12] 0 0
Salta
Country [13] 0 0
Belgium
State/province [13] 0 0
Anderlecht
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Belgium
State/province [14] 0 0
Charleroi
Country [15] 0 0
Belgium
State/province [15] 0 0
Edegem
Country [16] 0 0
Belgium
State/province [16] 0 0
Gent
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Belgium
State/province [18] 0 0
Liège
Country [19] 0 0
Belgium
State/province [19] 0 0
Sint-Lambrechts-Woluwe
Country [20] 0 0
Brazil
State/province [20] 0 0
Ceará
Country [21] 0 0
Brazil
State/province [21] 0 0
Paraná
Country [22] 0 0
Brazil
State/province [22] 0 0
Rio Grande Do Norte
Country [23] 0 0
Brazil
State/province [23] 0 0
Santa Catarina
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Brazil
State/province [24] 0 0
São Paulo
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Bulgaria
State/province [25] 0 0
Burgas
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Bulgaria
State/province [26] 0 0
Pleven
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Bulgaria
State/province [27] 0 0
Plovdiv
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Sofia
Country [29] 0 0
Canada
State/province [29] 0 0
Nova Scotia
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
Chile
State/province [31] 0 0
Reg Metropolitana De Santiago
Country [32] 0 0
Chile
State/province [32] 0 0
Valparaíso
Country [33] 0 0
China
State/province [33] 0 0
Beijing
Country [34] 0 0
China
State/province [34] 0 0
Changchun
Country [35] 0 0
China
State/province [35] 0 0
Changsha
Country [36] 0 0
China
State/province [36] 0 0
Chengdu
Country [37] 0 0
China
State/province [37] 0 0
Chongqing
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China
State/province [38] 0 0
Fuzhou
Country [39] 0 0
China
State/province [39] 0 0
Ganzhou
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China
State/province [40] 0 0
Guangzhou
Country [41] 0 0
China
State/province [41] 0 0
Hangzhou
Country [42] 0 0
China
State/province [42] 0 0
Harbin
Country [43] 0 0
China
State/province [43] 0 0
Hefei
Country [44] 0 0
China
State/province [44] 0 0
Huizhou
Country [45] 0 0
China
State/province [45] 0 0
Jinan
Country [46] 0 0
China
State/province [46] 0 0
Nanchang
Country [47] 0 0
China
State/province [47] 0 0
Nanjing
Country [48] 0 0
China
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Nanning
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China
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Tianjin
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China
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Wuhan
Country [51] 0 0
China
State/province [51] 0 0
Zhanjiang
Country [52] 0 0
China
State/province [52] 0 0
Zhengzhou
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China
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Zhongshan
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France
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Bordeaux Cedex
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France
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CAEN Cedex 05
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France
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Creteil
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France
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Dijon
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France
State/province [58] 0 0
GRENOBLE Cedex 9
Country [59] 0 0
France
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Marseille
Country [60] 0 0
France
State/province [60] 0 0
Montpellier
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France
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Paris
Country [62] 0 0
France
State/province [62] 0 0
Pierre Benite
Country [63] 0 0
France
State/province [63] 0 0
RENNES Cedex 09
Country [64] 0 0
France
State/province [64] 0 0
Saint Herblain
Country [65] 0 0
France
State/province [65] 0 0
Saint-mande
Country [66] 0 0
France
State/province [66] 0 0
Villejuif
Country [67] 0 0
Germany
State/province [67] 0 0
Essen
Country [68] 0 0
Germany
State/province [68] 0 0
Heidelberg
Country [69] 0 0
Greece
State/province [69] 0 0
Athens
Country [70] 0 0
Greece
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Heraklion
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Greece
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Ioannina
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Greece
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Larisa
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Greece
State/province [73] 0 0
Thessaloniki
Country [74] 0 0
Hungary
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Budapest
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Hungary
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Kaposvár
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India
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Bhubaneswar
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India
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Jaipur
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India
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New Delhi
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India
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Pune
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India
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Trivandrum
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Israel
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Haifa
Country [82] 0 0
Israel
State/province [82] 0 0
Kfar-Saba
Country [83] 0 0
Israel
State/province [83] 0 0
Petach Tikva
Country [84] 0 0
Italy
State/province [84] 0 0
Emilia-Romagna
Country [85] 0 0
Italy
State/province [85] 0 0
Milano
Country [86] 0 0
Italy
State/province [86] 0 0
Torino
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Italy
State/province [87] 0 0
Catania
Country [88] 0 0
Japan
State/province [88] 0 0
Aichi
Country [89] 0 0
Japan
State/province [89] 0 0
Fukuoka
Country [90] 0 0
Japan
State/province [90] 0 0
Hokkaido
Country [91] 0 0
Japan
State/province [91] 0 0
Hyogo
Country [92] 0 0
Japan
State/province [92] 0 0
Ishikawa
Country [93] 0 0
Japan
State/province [93] 0 0
Kanagawa
Country [94] 0 0
Japan
State/province [94] 0 0
Miyagi
Country [95] 0 0
Japan
State/province [95] 0 0
Osaka
Country [96] 0 0
Japan
State/province [96] 0 0
Shizuoka
Country [97] 0 0
Japan
State/province [97] 0 0
Tokyo
Country [98] 0 0
Japan
State/province [98] 0 0
Wakayama
Country [99] 0 0
Japan
State/province [99] 0 0
Yamaguchi
Country [100] 0 0
Korea, Republic of
State/province [100] 0 0
Busan-gwangyeoksi
Country [101] 0 0
Korea, Republic of
State/province [101] 0 0
Chungcheongbuk-do
Country [102] 0 0
Korea, Republic of
State/province [102] 0 0
Seoul-teukbyeolsi
Country [103] 0 0
Korea, Republic of
State/province [103] 0 0
Seoul
Country [104] 0 0
Lithuania
State/province [104] 0 0
Kaunas
Country [105] 0 0
Lithuania
State/province [105] 0 0
Vilnius
Country [106] 0 0
Mexico
State/province [106] 0 0
Ciudad De Mexico
Country [107] 0 0
Mexico
State/province [107] 0 0
Ciudad de Mexico
Country [108] 0 0
Netherlands
State/province [108] 0 0
's Hertogenbosch
Country [109] 0 0
Netherlands
State/province [109] 0 0
Breda
Country [110] 0 0
Netherlands
State/province [110] 0 0
Utrecht
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Poland
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Warminsko-mazurskie
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Poland
State/province [112] 0 0
Warsaw
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Portugal
State/province [113] 0 0
Almada
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Portugal
State/province [114] 0 0
Lisboa
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Portugal
State/province [115] 0 0
Porto
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Romania
State/province [116] 0 0
Alba Iulia
Country [117] 0 0
Romania
State/province [117] 0 0
Brasov
Country [118] 0 0
Romania
State/province [118] 0 0
Bucaresti
Country [119] 0 0
Romania
State/province [119] 0 0
Cluj-Napoca
Country [120] 0 0
Romania
State/province [120] 0 0
Cluj
Country [121] 0 0
Romania
State/province [121] 0 0
Craiova
Country [122] 0 0
Romania
State/province [122] 0 0
Otopeni
Country [123] 0 0
Romania
State/province [123] 0 0
Timisoara
Country [124] 0 0
Russian Federation
State/province [124] 0 0
Moscow
Country [125] 0 0
Russian Federation
State/province [125] 0 0
Saint -Petersburg
Country [126] 0 0
Singapore
State/province [126] 0 0
Singapore
Country [127] 0 0
Spain
State/province [127] 0 0
Barcelona [Barcelona]
Country [128] 0 0
Spain
State/province [128] 0 0
Madrid, Comunidad De
Country [129] 0 0
Spain
State/province [129] 0 0
Navarra
Country [130] 0 0
Spain
State/province [130] 0 0
Madrid
Country [131] 0 0
Spain
State/province [131] 0 0
Málaga
Country [132] 0 0
Spain
State/province [132] 0 0
Sevilla
Country [133] 0 0
Spain
State/province [133] 0 0
Valencia
Country [134] 0 0
Turkey
State/province [134] 0 0
Adana
Country [135] 0 0
Turkey
State/province [135] 0 0
Ankara
Country [136] 0 0
Turkey
State/province [136] 0 0
Istanbul
Country [137] 0 0
Turkey
State/province [137] 0 0
Izmir
Country [138] 0 0
Turkey
State/province [138] 0 0
Kocaeli
Country [139] 0 0
Turkey
State/province [139] 0 0
Malatya
Country [140] 0 0
United Kingdom
State/province [140] 0 0
Cornwall
Country [141] 0 0
United Kingdom
State/province [141] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04154956