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    Summary
    EudraCT Number:2021-002337-42
    Sponsor's Protocol Code Number:ETOP18-21
    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:2022-11-16
    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 number2021-002337-42
    A.3Full title of the trial
    A multicentre single-arm phase II trial of amivantamab, lazertinib plus bevacizumab in patients with EGFR-mutant advanced NSCLC with progression on previous third generation EGFR TKI
    Studio multicentrico, a braccio singolo, di fase II sull’efficacia di amivantamab, lazertinib e bevacizumab in pazienti con NSCLC avanzato con mutazione del gene EGFR e progressione su precedente terapia con inibitori EGFR di terza generazione.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study exploring the effect of amivantamab and lazertinib plus bevacizumab treatment, in people diagnosed with advanced non-small cell lung cancer (NSCLC) that shows a change (mutation) in the EGFR gene and has spread to other parts of the body during or after treatment with osimertinib or lazertinib.
    Studio clinico sull’effetto del trattamento con amivantamab e lazertinib abbinati a bevacizumab in pazienti con diagnosi di carcinoma polmonare non a piccole cellule (NSCLC) avanzato con cambiamento (mutazione) del gene EGFR e diffuso in altre parti del corpo durante o dopo il trattamento con osimertinib o lazertinib.
    A.3.2Name or abbreviated title of the trial where available
    AMAZE-lung
    AMAZE-lung
    A.4.1Sponsor's protocol code numberETOP18-21
    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 SponsorETOP IBCSG Partners Foundation
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Pharmaceutica
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationETOP IBCSG Partners Foundation
    B.5.2Functional name of contact pointCoordinating Center
    B.5.3 Address:
    B.5.3.1Street AddressEffingerstrasse 33
    B.5.3.2Town/ cityBern
    B.5.3.3Post code3008
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41315119400
    B.5.5Fax number+41315119401
    B.5.6E-mailetop-regulatory@etop.ibcsg.org
    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 nameAmivantamab
    D.3.2Product code [049823014]
    D.3.4Pharmaceutical form Concentrate for solution for injection/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 INNAmivantamab
    D.3.9.1CAS number 2171511-58-1
    D.3.9.2Current sponsor codeAmivantamab
    D.3.9.4EV Substance CodeSUB193051
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 Yes
    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 No
    D.IMP: 2
    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 nameLazertinib
    D.3.2Product code Lazertinib
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLazertinib
    D.3.9.1CAS number 1903008-80-9
    D.3.9.2Current sponsor codeLazertinib
    D.3.9.4EV Substance CodeSUB199596
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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) No
    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 No
    D.IMP: 3
    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 Yes
    D.2.1.1.1Trade name Zirabev
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameZirabev
    D.3.2Product code [047629]
    D.3.4Pharmaceutical form Concentrate for solution for injection/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 INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor codeBevacizumab
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 Yes
    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 No
    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
    patients with EGFR-mutant advanced NSCLC with progression on previous third generation EGFR TKI
    Pazienti affetti/e da NSCLC non squamoso avanzato con mutazione del gene EGFR (L858R o solo del19) e progressione dopo un precedente trattamento con inibitori EGFR di terza generazione.
    E.1.1.1Medical condition in easily understood language
    Patients with non-small cell lung cancer that:
    • Has a change (mutation) in a gene called EGFR
    • Has spread to other parts of the body during, or after treatment with osimertinib or lazertinib.
    Pazienti con carcinoma polmonare non a piccole cellule che:
    • cambiamento in un gene chiamato EGFR.
    • diffusione in altre parti del corpo durante o dopo il trattamento con osimertinib o lazertinib.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the trial is to assess the efficacy of amivantamab and bevacizumab added to continued treatment with a third-generation EGFR-TKI (osimertinib or lazertinib), in patients with EGFR-mutant advanced NSCLC, who have been previously treated with a third-generation EGFR-TKI in order to provide data on treatment effect and sample size required for a future phase III trial.
    L’obiettivo primario dello studio è valutare l’efficacia di amivantamab e bevacizumab in combinazione con la somministrazione continua di un inibitore EGFR di terza generazione (osimertinib o lazertinib) in pazienti con NSCLC avanzato con mutazione del gene EGFR, precedentemente trattati/e con inibitori EGFR di terza generazione, al fine di fornire dati sugli effetti del trattamento e ottenere un campione sufficiente per un futuro studio di fase III.
    E.2.2Secondary objectives of the trial
    - To evaluate secondary measures of clinical efficacy including progression-free survival (PFS), overall survival (OS), duration of response (DoR), disease control rate (DCR).

    - To assess the safety and tolerability of the treatment.
    - Valutare le misure secondarie di efficacia clinica, tra cui sopravvivenza libera da progressione (PFS), sopravvivenza complessiva (OS), durata della risposta (DoR), tasso di controllo della malattia (DCR).

    - Valutare la sicurezza e la tollerabilità del trattamento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically confirmed non-squamous NSCLC, stage IIIB/C (not amenable to radical therapy) or stage IV according to 8th TNM classification
    2. Presence of the sensitising EGFR-mutation (only patients with exon 19 deletion and/or L858R are eligible) and documentation of T790M status, tested locally by an accredited laboratory.
    3. Radiologically confirmed disease progression on previous treatment with osimertinib or lazertinib.
    Treatment with osimertinib or lazertinib must have been stopped at least 8 days before enrolment.
    4. Achieved objective clinical benefit from osimertinib or lazertinib treatment (e.g., documented PR/ CR or SD for =6 months while on osimertinib or lazertinib treatment).
    5. Measurable disease as defined according to RECIST v1.1.
    6. Age =18 years.
    1. NSCLC non squamoso e confermato istologicamente di stadio IIIB/C (non idoneo alla terapia radicale) o IV secondo l’ottava classificazione TNM.
    2. Presenza di una mutazione sensibilizzante del gene EGFR (solo i/le pazienti con mutazioni E19del e/o L858R sono idonei/e) e documentazione dello status T790M, confermati localmente da un laboratorio accreditato.
    3. Progressione della malattia confermata radiologicamente dopo un precedente trattamento con osimertinib o lazertinib. Il trattamento con osimertinib deve essere stato interrotto almeno 8 giorni prima dell’arruolamento.
    4. Raggiungimento di un beneficio clinico obiettivo con il trattamento con osimertinib o lazertinib (ad es. PR/CR o SD documentate per =6 mesi durante il trattamento con osimertinib o lazertinib).
    5. Malattia misurabile definita in base a RECIST v1.1.
    6. Età =18 anni
    E.4Principal exclusion criteria
    1. Patients with known small cell lung carcinoma (SCLC) transformation.
    2. Patients with symptomatic brain metastases.
    Patients with asymptomatic or previously treated and stable brain metastases may participate in this study. Patients who have received definitive radiotherapy or surgery for symptomatic or unstable brain metastases and have been clinically stable and asymptomatic for at =2 weeks before enrolment are eligible, provided they have been either off corticosteroid treatment or are receiving low-dose corticosteroid treatment (=10 mg/day prednisone or equivalent) for at least 2 weeks prior to enrolment.
    3. Patients with an active or past medical history of leptomeningeal disease.
    4. Patients with untreated spinal cord compression.
    Patients who have been definitively treated with surgery or radiotherapy and have a stable neurological status for =2 weeks prior to enrollment are eligible provided they are off corticosteroid treatment or are receiving low-dose corticosteroid treatment =10 mg/day prednisone or equivalent.
    5. Patients with unresolved adverse events (other than alopecia) from prior anticancer therapy that have not resolved to grade =1 or baseline.
    6. Patients with positive hepatitis B (hepatitis B virus [HBV]) surface antigen (HBsAg) test.
    1. Pazienti con trasformazione nota in carcinoma a piccole cellule (SCLC).
    2. Pazienti con metastasi cerebrali sintomatiche.
    I/le pazienti con metastasi cerebrali asintomatiche o precedentemente trattate e stabili potranno partecipare a questo studio. I/le pazienti sottoposti/e al trattamento chirurgico o radioterapico definitivo di metastasi cerebrali sintomatiche o instabili e clinicamente stabili e asintomatici/che per almeno =2 settimane prima dell’arruolamento sono idonei/e, purché non assumano un trattamento con corticosteroidi o ricevano un trattamento con corticosteroidi a basso dosaggio (=10 mg/die di prednisone o farmaco equivalente) per almeno 2 settimane prima dell’arruolamento.
    3. Pazienti con storia medica attuale o passata di malattia leptomeningea.
    4. Pazienti con compressione del midollo spinale non trattata.
    I/le pazienti con trattamento chirurgico o radioterapico definitivo e status neurologico stabile per =2 settimane prima dell’arruolamento sono idonei/e, purché non assumano un trattamento con corticosteroidi e ricevano un trattamento con corticosteroidi a basso dosaggio (=10 mg/die di prednisone o farmaco equivalente).
    5. Pazienti con eventi avversi (ad eccezione dell’alopecia) collegati a precedenti terapie oncologiche non ridotti al grado =1 o basale.
    6. Pazienti con test positivo per l'antigene di superficie dell'epatite B (virus dell'epatite B [HBV]) (HBsAg).
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate (ORR), investigator assessed, at 12 weeks according to RECIST v1.1
    Tasso di risposta obiettiva (ORR), valutato dallo sperimentatore, a 12 settimane in base a RECIST v1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    interim analysis (1 year) and final analysis (2 years)
    analisi ad interim (1 anno) e analisi finale (2 anni)
    E.5.2Secondary end point(s)
    1. Duration of response (DoR)
    2. Progression-free survival (PFS) according to RECIST v1.1
    3. Disease control rate (DCR) according to RECIST v1.1
    4. Overall survival (OS)
    5. Safety and tolerability (CTCAE v5.0)
    1. Durata della risposta (DoR)
    2. Sopravvivenza libera da progressione (PFS) secondo RECIST v1.1.
    3. Tasso di controllo della malattia (DCR) secondo RECIST v1.1
    4. Sopravvivenza complessiva (OS)
    5. Sicurezza e tollerabilità (CTCAE v5.0)
    E.5.2.1Timepoint(s) of evaluation of this end point
    final analysis (2 years)
    analisi finale (2 anni)
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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
    bracco singolo
    Single-arm
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Korea, Republic of
    Singapore
    France
    Netherlands
    Spain
    Switzerland
    Italy
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    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 months6
    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 months6
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 60
    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
    NA
    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 Decision2023-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-26
    P. End of Trial
    P.End of Trial StatusOngoing
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