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    EudraCT Number:2019-003916-29
    Sponsor's Protocol Code Number:TREASURE
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-03-30
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2019-003916-29
    A.3Full title of the trial
    Thoracic RadiothErapy with Atezolizumab in Small cell lUng canceR Extensive disease: a randomized, open-label, multicenter phase II study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Thoracic RadiothErapy with Atezolizumab in Small cell lUng canceR Extensive disease
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberTREASURE
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04462276
    A.5.4Other Identifiers
    Name:Roche CodeNumber: ML41633
    Name:AIO Study NumberNumber:AIO-TRK-0320
    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 SponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
    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 supportRoche Pharma AG
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street AddressSteinbacher Hohl 2-26
    B.5.3.2Town/ cityFrankfurt
    B.5.3.3Post code60385
    B.5.4Telephone number+496976014420
    B.5.5Fax number+496976013655
    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. name Tecentriq® 1.200 mg
    D. of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 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.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
    Small cell lung cancer extensive disease
    E.1.1.1Medical condition in easily understood language
    Small cell lung cancer extensive disease
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to investigate the treatment efficacy of combining thoracic radiotherapy (TRT) with the IMpower133 regimen in the upfront treatment of ED SCLC patients.
    The study is designed in an attempt to increase the efficacy of atezolizumab maintenance after induction with chemo/atezolizumab by adding radiotherapy.
    E.2.2Secondary objectives of the trial
    Additionally, with this study, we aim to determine the safety and tolerability of the combination of immunological and radiological treatment in the first-line setting of advanced SCLC.
    Furthermore, we aim to collect blood, stool and tissue samples prospectively for the separate translational program.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Fully-informed written consent and locally required authorization (European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
    2. Age ≥ 18 years.
    3. Histologically or cytologically confirmed ED SCLC as defined according to the Veterans Administration Lung Study Group staging system.
    4. Measurable ED SCLC according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. In cases of CR or PR without residual measurable disease after 4 cycles of induction therapy, patients may still be included. In such cases “No Evidence of Disease (NED)” should be reported in eCRF.
    5. ECOG performance-status score of 0 or 1 at screening
    6. Any response after four cycles of standard chemo-immunotherapy (carboplatin, etoposide, atezolizumab) defined as CR/PR or thoracic SD with CR/PR of extrathoracic lesions as per RECIST 1.1
    7. Thoracic treatment volume considered treatable using acceptable radiation fields as judged by a radiation oncologist
    8. 28 ± 7 days between last administration of chemo-immunotherapy (carboplatin, etoposide, atezolizumab) and randomization.
    9. Patients with a history of treated CNS metastases are eligible, if there is no ongoing requirement for corticosteroids as therapy for CNS disease. Before randomization, MRI of brain (with contrast, unless contraindicated) is recommended in subjects with suspected or known brain metastases, as per local standard., Patients with asymptomatic brain metastases that do not require local therapy with irradiation (whole brain irradiation) can be included. In ambiguous cases, consultation with the LKP or his/her delegate is advised.
    10. No previous radiotherapy to thorax lung and mediastinal lymph nodes within the past 5 years before the first dose of study drug
    11. Availability of pre-treatment tumor tissue specimen
    12. The patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations.
    13. FEV1 ≥ 40% (%Soll)
    14. Adequate bone marrow and renal function including the following:
    • Hemoglobin ≥ 9.0 g/dL;
    • Absolute neutrophil count ≥ 1.0 x 10^9/L;
    • Platelets ≥75x 10^9/L;
    • Calculated creatinine clearance ≥30 mL/min as determined by the Cockcroft-Gault equation
    15. Adequate hepatic function (with stenting for any obstruction, if required) including the following:
    • Serum bilirubin ≤ 3 x institutional upper limit of normal (ULN);
    • AST (SGOT) / ALT (SGPT) and alkaline phosphatase ≤ 2.5x ULN
    Following exceptions apply:
    • Patients with documented liver metastases: AST and/or ALT ≤ 5x ULN
    • Patients with documented liver or bone metastases: alkaline phosphatase ≤ 5x ULN.
    16. Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.
    17. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
    • Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
    • Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
    E.4Principal exclusion criteria
    1. Previous treatment with CD137 agonists, immune-checkpoint blockade therapies, anti-PD-1, or anti-PD-L1 therapeutic antibodies (with the exclusion of prior immunotherapy as defined in inclusion criterion 6).
    2. Prior therapy for limited-stage SCLC with curative intent.
    3. Prior radiotherapy of lung and mediastinal lymph nodes within the past 5 years before the first dose of study drug.
    4. Oxygen-dependent medical condition.
    5. History or current radiology suggestive of interstitial lung disease (ILD) (including but not limited to idiopathic pulmonary fibrosis (IPF)/usual interstitial pneumonia (UIP)/cryptogenic fibrosing alveolitis (CFA)), non-infectious pneumonitis, drug-induced pneumonitis, idiopathic pneumonitis.
    6. Criterion removed.
    7. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study, or during the follow-up period of an interventional study.
    8. Participation in another clinical study with an investigational product within 21 days prior to the first dose of the study treatment.
    9. Any concurrent chemotherapy, investigational product (IMP), biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer related conditions (e.g. hormone replacement therapy) is acceptable.
    10. Major surgery (as defined by the Investigator) within 4 weeks prior to enrollment into the study; patients must have recovered from effects of any major surgery. Note: Local non-major surgery for palliative intent is acceptable.
    11. Active or prior documented autoimmune or inflammatory disorders (including but not limited to diverticulitis [with the exception of diverticulosis], celiac disease, systemic lupus erythematosus, Sarcoidosis, or Wegener’s syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis). The following are exceptions to this criterion:
    o Patients with vitiligo or alopecia
    o Patients with hypothyroidism (e.g., following Hashimoto’s disease) stable on hormone replacement
    o Patients with controlled Type I diabetes mellitus on an insulin regimen
    o Any chronic skin condition that does not require systemic therapy
    o Patients without active disease in the last 5 years may be included but only after consultation with the study physician.
    12. Active, uncontrolled inflammatory bowel disease [e.g. ulcerative colitis or Crohn's disease]. Patients in stable remission for more than 1 year may be included.
    13. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, interstitial lung disease, gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
    14. History of another primary malignancy except for:
    o Malignancy treated with curative intent and with no known active disease ≥ 3 years before the first dose of IMP and of low potential risk for recurrence
    o Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
    o Adequately treated carcinoma in situ without evidence of disease
    15. History of active primary immunodeficiency
    16. History of allogenic organ or tissue transplantation.
    17. Clinical diagnosis of active tuberculosis.
    18. Positive testing for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
    19. Positive testing for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
    20. Current or prior use of immunosuppressive medication within 14 days before the first dose of atezolizumab. The following are exceptions to this criterion:
    o Intranasal, inhaled, topical steroids, or local steroid injections (e.g. intra articular injection)
    o Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
    o Steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication)
    21. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 5 months after the last dose of atezolizumab monotherapy.
    22. Known allergy or hypersensitivity to the IMP or any of the constituents of the product.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is overall survival (OS), defined as time from randomization to death due to any cause. The primary endpoint will be evaluated as a time-to-event variable using a Cox proportional hazards model.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at study end / after LVLS
    E.5.2Secondary end point(s)
    • 1- and 2-year OS rate
    • PFS (according to RECIST 1.1 and iRECIST)
    • Response rate (according to RECIST 1.1 and iRECIST)
    • Disease control rate (according to RECIST 1.1 and iRECIST)
    • Intrathoracic tumor control (defined as the time to intrathoracic progression which is defined as time from randomization until an intrathoracic progression according to RECIST 1.1)
    • Extrathoracic tumor control (defined as the time to extrathoracic progression which is defined as time from randomization until extrathoracic progression according to RECIST 1.1).
    • Safety in terms of
    - Incidence, nature, causal relationship and severity of Adverse Events according to NCI CTCAE v5.0
    - Frequency of abnormal laboratory parameters
    • Feasibility in terms of:
    - frequency of treatment withdrawal (either due to adverse events or other reasons)
    - completion of radiotherapy
    • Cancer related quality of life (FACT-L)
    • Collection of biomarker samples for separate biomarker research project
    E.5.2.1Timepoint(s) of evaluation of this end point
    • all secondary endpoints will be finally evaluated at study end (after LVLS)
    • 1- and 2-year OS rate: additionally at 1 and 2 years after LPI
    • Safety will be evaluated continously and after LVLS
    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 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. 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 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 Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E. description
    Atezolizumab maintenance without thoracic radiotherapy
    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 concerned18
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    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 months0
    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 months0
    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: 34
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state94
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 104
    F.4.2.2In the whole clinical trial 104
    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)
    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 Decision2020-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-25
    P. End of Trial
    P.End of Trial StatusOngoing
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