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    Summary
    EudraCT Number:2021-004423-32
    Sponsor's Protocol Code Number:ACT17241
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-12-17
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-004423-32
    A.3Full title of the trial
    Open-label, Phase 2 study, evaluating the efficacy and safety of tusamitamab ravtansine in non-squamous non-small-cell lung cancer (NSQ NSCLC) participants with negative or moderate CEACAM5 expression tumors and high circulating CEA
    Studio di fase 2, in aperto, volto a valutare l’efficacia e la sicurezza di tusamitamab ravtansine in partecipanti affetti da tumore del polmone non a piccole cellule, non squamoso (NSQ NSCLC) con espressione negativa o moderata di CEACAM5 e livelli elevati di CEA circolante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tusamitamab ravtansine in NSQ NSCLC participants with negative or moderate CEACAM5 expression tumors and high circulating CEA
    Tusamitamab ravtansine in partecipanti affetti da NSQ NSCLC con espressione negativa o moderata di CEACAM5 e livelli elevati di CEA circolante
    A.3.2Name or abbreviated title of the trial where available
    CARMEN-LC06
    CARMEN-LC06
    A.4.1Sponsor's protocol code numberACT17241
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1264-2828
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSanofi Aventis Recherche & Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSANOFI S.r.l.
    B.5.2Functional name of contact pointContact Point
    B.5.3 Address:
    B.5.3.1Street AddressViale Luigi Bodio 37/B
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20158
    B.5.3.4CountryItaly
    B.5.4Telephone number800536389
    B.5.5Fax number000000
    B.5.6E-mailinformazioni.medicoscientifiche@sanofi.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTusamitamab ravtansine
    D.3.2Product code [SAR408701]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTusamitamab ravtansine
    D.3.9.2Current sponsor codeSAR408701
    D.3.9.4EV Substance CodeSUB130908
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeanticorpo coniugato Maytansina anti CEACAM - 5
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non-squamous non-small-cell lung cancer
    tumore del polmone non a piccole cellule, non squamoso
    E.1.1.1Medical condition in easily understood language
    Lung cancer
    tumore del polmone
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10079440
    E.1.2Term Non-squamous non-small cell lung cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the anti-tumor activity of tusamitamab ravtansine when given every 2 weeks (Q2W) in non squamous non-small-cell-lung-cancer (NSQ NSCLC) participants with negative or moderate CEACAM5 expression tumors and high circulating carcinoembryonic antigen (CEA) levels
    Valutare l’attività antitumorale di tusamitamab ravtansine quando somministrata ogni 2 settimane (Q2W) in partecipanti affetti da tumore del polmone non a piccole cellule non squamoso (NSQ NSCLC) con tumori ad espressione negativa o moderata di CEACAM5 e livelli elevati di antigene carcino-embrionario circolante (CEA)
    E.2.2Secondary objectives of the trial
    - To assess the safety and tolerability of tusamitamab ravtansine
    - To assess other efficacy parameters of tusamitamab ravtansine
    - To assess immunogenicity of tusamitamab ravtansine
    - To document the pharmacokinetics (PK) of tusamitamab ravtansine
    - Valutare la sicurezza e la tollerabilità di tusamitamab ravtansine
    - Valutare altri parametri di efficacia di tusamitamab ravtansine
    - Valutare l’immunogenicità di tusamitamab ravtansine
    - Documentare la farmacocinetica (PK) di tusamitamab ravtansine
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically or cytologically proven diagnosis of NSQ NSCLC metastatic disease at study entry; progression after platinum-based chemotherapy and immune checkpoint inhibitor.
    - Participants with moderate or negative CEACAM5 expression as demonstrated prospectively by central laboratory via immune histochemistry (ICH) and high circulating CEA levels (>= 100 ng/mL). Moderate CEACAM5 expression is defined as intensity >= 2 + in >= 1% and <50 % of tumor cells. Negative CEACAM5 expression is defined as intensity of 1 + whatever the percentage of stained tumor cells or <1% of tumor cells.
    - At least one measurable lesion by RECIST v1.1
    - Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
    - Women of childbearing potential or male patient with women of childbearing potential who agree to use highly effective method of birth control.
    - Diagnosi istologicamente o citologicamente comprovata di NSQ NSCLC metastatico all’ingresso nello studio; Progressione di malattia dopo un trattamento chemioterapico a base di platino e un inibitore dei checkpoint immunitari
    - Pazienti con espressione moderata o negativa di CEACAM5 valutata in modo prospettico mediante un test immunoistochimico IHC centrale e alti livelli di CEA circolante (>=100 ng/ml). L’espressione moderata di CEACAM5 è definita come intensità >= 2+ in >=1% e <50% delle cellule tumorali. L’espressione negativa di CEACAM5 è definita come intensità 1+, indipendentemente dalla percentuale di cellule tumorali marcate o <1% delle cellule tumorali.
    - Almeno una lesione misurabile secondo i criteri RECIST v1.1
    - Performance status compreso tra 0-1 secondo l’Eastern Cooperative Oncology Group (ECOG).
    - Donne in età fertile o pazienti di sesso maschile con donne in età fertile che accettano di utilizzare un metodo contraccettivo altamente efficace.
    E.4Principal exclusion criteria
    - Patients with untreated brain metastases or history of leptomeningeal disease.
    - 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.
    - History of known uncontrolled infection with human immunodeficiency virus (HIV), or unresolved viral hepatitis.
    - Significant concomitant illness that could impair the participation in the study. or interpretation of the results or any major surgery with 3 weeks prior treatment administration.
    - Nonresolution of any prior treatment-related toxicity to <Grade 2 according to NCI CTCAE v5.0, with the exception of alopecia, vitiligo, or active thyroiditis controlled with hormone replacement therapy.
    - Previous history of and/or unresolved corneal disorders. The use of contact lenses is not permitted.
    - Prior treatment with maytansinoid derivatives (DM1 or DM4 antibody drug conjugate) or any drug targeting CEACAM5.
    - Concurrent treatment with any other anticancer therapy
    - Poor bone marrow, liver or kidney functions.
    - Pazienti con metastasi cerebrali non trattate o anamnesi di malattia leptomeningea.
    - Anamnesi entro gli ultimi 3 anni di un tumore maligno invasivo diverso da quello trattato in questo studio, a eccezione del carcinoma cutaneo basocellulare o squamocellulare sottoposto a resezione/ablazione o del carcinoma in situ della cervice o altri tumori locali considerati curati mediante trattamento locale.
    - Infezione nota non controllata da virus dell’immunodeficienza umana (HIV), o epatite virale non risolta.
    - Malattie concomitanti significative che ostacolerebbero la partecipazione del/la partecipante allo studio. O l’interpretazione dei risultati o qualsiasi intervento chirurgico maggiore 3 settimane prima della somministrazione del trattamento.
    - Mancata risoluzione della tossicità correlata a trattamenti precedenti fino a <grado 2 in base ai criteri NCI CTCAE V5.0, eccetto per alopecia, vitiligine o tiroidite attiva controllata con terapia ormonale sostitutiva .
    - Precedenti disturbi corneali e/o disturbi corneali irrisolti. L’uso delle lenti a contatto non è consentito.
    - Precedente trattamento con derivati maitansinoidi (coniugato anticorpo-farmaco DM1 o DM4) o precedente terapia mirata contro CEACAM5.
    - Trattamento concomitante con altra terapia antitumorale.
    - Scarsa funzionionalità del midollo osseo, del fegato o dei reni.
    E.5 End points
    E.5.1Primary end point(s)
    Objective Response Rate (ORR), defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) as best overall response (BOR) per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
    Tasso di risposta oggettiva (ORR), definito come la percentuale di partecipanti che presenta una risposta completa (CR) o una risposta parziale (PR) confermata come migliore risposta complessiva (BOR) secondo i Criteri di valutazione della risposta nei tumori solidi (RECIST) v1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline up to approximately 9 months after last patient treated
    Dal basale fino a circa 9 mesi dopo l'ultimo paziente trattato
    E.5.2Secondary end point(s)
    1) Incidence of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and laboratory abnormalities according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
    2) Progression-free survival (PFS) defined as the time from the date of first tusamitamab ravtansine administration to the date of the first documented disease progression or death due to any cause, whichever comes first.
    3) Disease control rate (DCR) defined as the percentage of participants who have achieved confirmed CR or PR, or stable disease as BOR per RECIST v1.1
    4) Duration of response (DOR), defined as the time from first documented evidence of CR or PR until progressive disease (PD) determined per RECIST v1.1 or death from any cause, whichever occurs first
    5) Incidence of participants with anti-therapeutic antibodies (ATAs) against tusamitamab ravtansine
    1) Incidenza di partecipanti con eventi avversi emergenti dal trattamento (TEAE) ed eventi avversi seri (SAE) e alterazioni dei valori di laboratorio secondo i Criteri terminologici comuni per gli eventi avversi (CTCAE) del National Cancer Institute (NCI) v5.0
    2) Sopravvivenza libera da progressione di malattia (PFS), definita come il tempo intercorrente dalla data della prima somministrazione di tusamitamab ravtansine alla data della prima progressione di malattia documentata o al decesso per qualsiasi causa, a seconda di quale evento si verifichi prima
    3) Tasso di controllo della malattia (DCR), definito come la percentuale di partecipanti che ha ottenuto una CR o PR confermata o con malattia stabile come BOR secondo i criteri RECIST v1.1
    4) La durata della risposta (DOR), definita come il tempo intercorrente dalla prima evidenza documentata di CR o PR fino a malattia progressiva (PD) come determinato dai criteri RECIST v1.1 o decesso per qualsiasi causa, a seconda di quale evento si verifichi prima
    5) Incidenza di partecipanti con anticorpi contro il farmaco (ATA) contro tusamitamab ravtansine
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Baseline up to approximately 90 days after the last study treatment administration
    2,3,4) Baseline up to approximately 9 months after last patient treated
    5) Baseline up to approximately 30 days after the last study treatment administration
    1) Dal basale fino a circa 90 giorni dopo l'ultima somministrazione del trattamento in studio
    2,3,4) Dal basale fino a circa 9 mesi dopo l'ultimo paziente trattato
    5) Dal basale fino a circa 30 giorni dopo l'ultima somministrazione del trattamento in studio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Studio in aperto
    open label
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Turkey
    Belgium
    Italy
    Japan
    Russian Federation
    Spain
    United States
    France
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 27
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 29
    F.4.2.2In the whole clinical trial 45
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    nessuna
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-22
    P. End of Trial
    P.End of Trial StatusOngoing
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