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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
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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
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Secondary ID [1]
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U1111-1233-0781
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Secondary ID [2]
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EFC15858
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Universal Trial Number (UTN)
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Trial acronym
CARMEN-LC03
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer Metastatic
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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0
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression free survival (PFS)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to up to approximately 15 months
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Primary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS will be defined as the time of randomization to the date of death due to any cause.
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Timepoint [2]
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Baseline up to approximately 2 years
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Secondary outcome [1]
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Objective response rate (ORR)
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Assessment method [1]
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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
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Timepoint [1]
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Baseline up to approximately 2 years
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Secondary outcome [2]
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Health related quality of life (HRQOL) - disease related symptoms
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Assessment method [2]
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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
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Timepoint [2]
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Baseline up to median 12 months
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Secondary outcome [3]
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Health related quality of life (HRQOL) - physical function
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Assessment method [3]
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TTD in physical function as determined by EORTC QLQ C30
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Timepoint [3]
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Baseline up to median 12 months
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Secondary outcome [4]
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Health related quality of life (HRQOL) - role function
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Assessment method [4]
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TTD in role function as determined by EORTC QLQ C30
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Timepoint [4]
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Baseline up to median 12 months
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Secondary outcome [5]
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Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
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Assessment method [5]
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Incidence of TEAEs and SAEs and laboratory abnormalities according to NCI CTCAE V5
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Timepoint [5]
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Baseline up to end of study (approximately 2 years)
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Secondary outcome [6]
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Duration of response (DOR)
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline up to approximately 2 years
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/02/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
26/08/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
411
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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Investigational Site Number : 0360002 - Blacktown
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Investigational Site Number : 0360003 - Waratah
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Recruitment hospital [3]
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Investigational Site Number : 0360001 - Woolloongabba
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2148 - Blacktown
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2298 - Waratah
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4102 - Woolloongabba
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's Hertogenbosch
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Netherlands
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Breda
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Netherlands
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Utrecht
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Poland
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Warminsko-mazurskie
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Poland
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Warsaw
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Portugal
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Almada
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Portugal
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Lisboa
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Portugal
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Porto
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Romania
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Alba Iulia
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Romania
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Brasov
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Romania
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Bucaresti
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Romania
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Bucuresti
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Romania
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Cluj-Napoca
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Romania
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Cluj
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Romania
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Craiova
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Romania
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Otopeni
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Romania
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Timisoara
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Russian Federation
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Moscow
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Russian Federation
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Saint -Petersburg
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Singapore
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Singapore
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Spain
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Barcelona [Barcelona]
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Spain
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Madrid, Comunidad De
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Spain
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Madrid
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Spain
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Navarra
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Spain
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Málaga
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Spain
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Sevilla
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Spain
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Valencia
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Kocaeli
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Turkey
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Malatya
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United Kingdom
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Cornwall
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sanofi
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Address
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Ethics approval
Ethics application status
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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
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Trial website
https://clinicaltrials.gov/study/NCT04154956
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Public notes
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Contacts
Principal investigator
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Clinical Sciences & Operations
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Sanofi
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04154956