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    Summary
    EudraCT Number:2021-004155-16
    Sponsor's Protocol Code Number:CAAA601A42101
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-12-27
    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 ConcernedGermany - PEI
    A.2EudraCT number2021-004155-16
    A.3Full title of the trial
    A Phase Ib/II Dose Finding Study Assessing Safety and Efficacy of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Extensive Stage Small Cell Lung Cancer (ES-SCLC) in Combination with Carboplatin, Etoposide and Atezolizumab in Induction and with Atezolizumab in Maintenance Phase
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase Ib study investigating dose, safety and efficacy of [177Lu]Lu-DOTA-TATE in patients with Extensive Stage Small Cell Lung Cancer (specific form of lung tumour)
    A.4.1Sponsor's protocol code numberCAAA601A42101
    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 SponsorNovartis Pharma AG
    B.1.3.4CountryUnited States
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma GmbH
    B.5.2Functional name of contact pointMedizinischer Infoservice (MCC)
    B.5.3 Address:
    B.5.3.1Street AddressRoonstrasse 25
    B.5.3.2Town/ cityNürnberg
    B.5.3.3Post code90429
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 1802 232300
    B.5.5Fax number +49 911 27312160
    B.5.6E-mailinfoservice.novartis@novartis.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 Yes
    D.2.1.1.1Trade name Lutathera
    D.2.1.1.2Name of the Marketing Authorisation holderAdvanced Accelerator Applications
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form 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 INNLUTETIUM (177LU) OXODOTREOTIDE
    D.3.9.2Current sponsor codeAAA601
    D.3.9.4EV Substance CodeSUB180110
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number370
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product Yes
    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: 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 Yes
    D.2.1.1.1Trade name NETSPOT
    D.2.1.1.2Name of the Marketing Authorisation holderAdvanced Accelerator Applications USA, Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical form Kit for radiopharmaceutical preparation
    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 INNNot yet available
    D.3.9.2Current sponsor codeAAA501
    D.3.9.3Other descriptive nameDOTATATE
    D.3.9.4EV Substance CodeSUB181362
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product Yes
    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 Baize’an
    D.2.1.1.2Name of the Marketing Authorisation holderBeigene Ltd
    D.2.1.2Country which granted the Marketing AuthorisationChina
    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 nameTislelizumab
    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 INNTislelizumab
    D.3.9.1CAS number 1858168-59-8
    D.3.9.2Current sponsor codeVDT482
    D.3.9.3Other descriptive nameBGN-A317
    D.3.9.4EV Substance CodeSUB193656
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    Extensive-Stage Small Cell Lung Cancer
    E.1.1.1Medical condition in easily understood language
    Specific form of lung tumour
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10041068
    E.1.2Term Small cell lung cancer extensive stage
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the Phase Ib portion of the study is to establish
    the recommended dose of [177Lu]Lu-DOTA-TATE in combination with
    carboplatin, etoposide, and atezolizumab in induction treatment and
    with atezolizumab in maintenance treatment in newly diagnosed
    participants with ES-SCLC.
    The primary objective of the Phase II portion of the study is to assess
    efficacy of [177Lu]Lu-DOTA-TATE in combination with carboplatin,
    etoposide and atezolizumab (experimental arm) versus standard of care
    consisting of carboplatin, etoposide, and atezolizumab (control arm) in
    terms of overall survival.
    E.2.2Secondary objectives of the trial
    Phase Ib:
    • To assess the preliminary anti-tumor activity of [177Lu]Lu-DOTA-TATE in combination with carboplatin, etoposide and atezolizumab in newly diagnosed participants with ES-SCLC
    • To characterize the pharmacokinetics (PK) and dosimetry of [177Lu]Lu-DOTA-TATE in participants with newly diagnosed participants with ES-SCLC

    Phase II:
    • To evaluate the antitumor activity of [177Lu]Lu-DOTA-TATE in
    combination with carboplatin, etoposide and atezolizumab (experimental arm) versus standard of care consisting of carboplatin, etoposide, and atezolizumab (control arm)

    Phase Ib and Phase II:
    • To characterize the safety and tolerability of [177Lu]Lu-DOTA-TATE in combination with carboplatin, etoposide, and atezolizumab in induction treatment and with atezolizumab in maintenance treatment in newly diagnosed participants with ES-SCLC
    • To assess the safety and tolerability of [68Ga]Ga-DOTA-TATE in
    participants with newly diagnosed ES-SCLC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key Inclusion Criteria:
    • Participant is ≥ 18 years on the day of signing informed consent form
    • Histologically or cytologically confirmed ES-SCLC
    • Presence of measurable disease (at least one target lesion) according to RECIST v1.1 assessed by conventional computed tomography (CT) scan
    • SSTR positive [68Ga]Ga-DOTA-TATE imaging positron emission tomography (PET) scan demonstrating uptake equal or higher than the liver uptake (uptake intensity score 2 or above in the visual uptake scoring scale) in at least one target or non-target lesion
    • No prior systemic treatment for ES-SCLC (except the first cycle of
    chemotherapy with or without atezolizumab of the induction period)
    • Provision of tumor tissue to support exploratory biomarker analysis
    • Life expectancy of >=6 months
    E.4Principal exclusion criteria
    Key exclusion Criteria:
    • Participant has received prior therapy with an antibody or drug against immune checkpoint pathways
    • Active leptomeningeal disease or uncontrolled, untreated brain metastasis
    • Any major surgical procedure requiring general anesthesia =< 28 days before Cycle 2 Day 1
    • History of current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for participants participating in the study
    • Known hypersensitivity to the active substances or any of the excipients of the study drugs
    • Concurrent participation in another therapeutic clinical study
    E.5 End points
    E.5.1Primary end point(s)
    Phase Ib:
    • Frequency of dose limiting toxicities (DLTs), incidence of adverse events (AEs), serious AEs (SAEs), and AEs leading to treatment discontinuation
    Phase II:
    • Overall Survival (OS) defined as time from date of randomization to death due to any cause
    E.5.1.1Timepoint(s) of evaluation of this end point
    Frequency of DLTs: Within the first 6 weeks of [177Lu]Lu-DOTA-TATE treatment
    Incidence of adverse events (AEs), serious AEs (SAEs), and AEs leading to treatment discontinuation: From date of randomization to 8 weeks following the last dose of study treatment

    OS: Time from date of randomization to death due to any cause
    E.5.2Secondary end point(s)
    Phase Ib:
    • Objective Response Rate (ORR), Duration of Response (DOR), Progression-Free Survival (PFS), Overall Survival (OS)
    • Time activity curves (TACs), describing % of the activity injected vs time in blood, organs and tumor lesions.
    • Absorbed radiation doses of [177Lu]Lu-DOTA-TATE in organs and tumor lesions
    • Concentration of [177Lu]Lu-DOTA-TATE in blood over time and derived PK parameters
    • Quantification of [177Lu]Lu-DOTA-TATE excreted from the body in urine from the start of infusion until the first whole body planar imaging

    Phase II:
    • Progression free survival (PFS) by investigator assessment, Objective Response Rate (ORR), Duration of Response (DOR) based on investigator assessment as per RECIST 1.1

    Phase Ib and Phase II:
    • Incidence and severity of Adverse Events (AEs) and serious Adverse Events (SAEs)
    • Incidence and severity of Adverse Events (AEs) and serious Adverse Events (SAEs) within 48 hours after [68Ga]Ga-DOTA-TATE infusion
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Incidence and severity of AEs and SAEs - from randomization until 30 days after safety follow-up.
    •ORR, DOR, PFS, OS : from randomization until date of progression or date of death from any cause, whichever comes first
    •Time activity curves (TACs), absorbed radiation doses of [177Lu]Lu and concentration of [177Lu]Lu-DOTA-TATE in blood: week 7 day 3
    •Quantification of [177Lu]Lu excreted from the body in urine: from the start of infusion until the first whole body planar imaging
    •Incidence and severity of AEs and SAEs of [68Ga]Ga: within 48h after administration
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Dosimetry, tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    A Phase Ib Dose Finding Study Assessing Safety and Activity
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Switzerland
    United Kingdom
    United States
    France
    Germany
    Spain
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months3
    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: 87
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 113
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Consent is allowed to be given by participant’s representative
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 200
    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)
    Once study treatment is completed the provision of [177Lu]Lu-DOTA-TATE is not considered necessary, as per protocol this is a treatment with a maximum cumulative dose of 1500 mCi. Continuing care should be provided by the Investigator and/or referring physician based on participant availability for follow-up.
    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 Decision2022-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-13
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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