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    Summary
    EudraCT Number:2015-004861-97
    Sponsor's Protocol Code Number:GO30081
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-06-29
    Trial results View 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 ConcernedCzechia - SUKL
    A.2EudraCT number2015-004861-97
    A.3Full title of the trial
    A PHASE I/III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF CARBOPLATIN PLUS ETOPOSIDE WITH OR WITHOUT ATEZOLIZUMAB (ANTIPD-L1 ANTIBODY) IN PATIENTS WITH UNTREATED EXTENSIVE-STAGE SMALL CELL LUNG CANCER
    RANDOMIZOVANÉ, DVOJITĚ ZASLEPENÉ, PLACEBEM KONTROLOVANÉ KLINICKÉ HODNOCENÍ FÁZE I/III POSUZUJÍCÍ KARBOPLATINU PLUS ETOPOSID V KOMBINACI S ATEZOLIZUMABEM (PROTILÁTKOU PROTI PDL1), NEBO BEZ NĚJ U PACIENTŮ S NELÉČENÝM MALOBUNĚČNÝM KARCINOMEM PLIC V POKROČILÉM STADIU
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Carboplatin plus Etoposide With or Without Atezolizumab in Patients with Untreated Extensive-Stage Small Cell Lung Cancer
    Studie s Karbopaltinou a Etoposidem s nebo bez Atezolizumabu u pacientů s neléčeným malobuněčným karcinomem plic v pokročilém stadiu
    A.4.1Sponsor's protocol code numberGO30081
    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 SponsorF. Hoffman-La Roche Ltd.
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.Hoffmann-La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameAtezolizumab (MPDL3280A-RO5541267)
    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 INNATEZOLIZUMAB
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    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
    E.1.1.1Medical condition in easily understood language
    Small cell lung cancer is a disease in which malignant (cancer) cells form in the tissues of the lung
    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 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
    • To evaluate the efficacy of atezolizumab (Atezo) + carboplatin (Carb) + etoposide (Etop) compared with placebo + Carb + Etop in the intent-to-treat (ITT) population as measured by investigator-assessed progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1)
    • To evaluate the efficacy of Atezo + Carb + Etop compared with placebo + Carb + Etop in the ITT population as measured by overall survival (OS)
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of Atezo + Carb + Etop compared with placebo+Carb+Etop in the ITT population as measured by investigator-assessed objective response rate (ORR) and duration of response (DOR) according to RECIST v1.1
    • To evaluate PFS rate at 6 months and at 1 year and OS rate at 1 and 2 years in each treatment arm for the ITT population
    • To determine the impact of Atezo as measured by time to deterioration (TTD) in patient-reported lung cancer symptoms in each treatment arm for the ITT population
    •To evaluate safety and tolerability of Atezo+Carb+Etop compared with Carb and Etop
    •To evaluate incidence and titers of anti-therapeutic antibodies (ATAs) against Atezo and to explore the potential relationship of the immunogenicity response with pharmacokinetics, safety, and efficacy
    •To characterize pharmacokinetics of Atezo, Carb, and Etop in chemotherapy-naive patients with extensive-stage small cell lung cancer (ES-SCLC)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female, 18 years of age or older
    - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    - Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group (VALG) staging system
    - No prior systemic treatment for ES-SCLC
    - Patients who have received prior chemoradiotherapy for limited-stage SCLC must have been treated with curative intent and experienced a treatment-free interval of at least 6 months since last chemotherapy, radiotherapy, or chemoradiotherapy cycle from diagnosis of extensive-stage SCLC
    - Patients with treated asymptomatic CNS metastases are eligible (only supratentorial and cerebellar metastases allowed)
    - Measurable disease, as defined by RECIST v1.1
    - Adequate haematologic and end organ function
    - Patients must submit a pre-treatment tumour tissue sample during the study. Any available tumour tissue sample can be submitted. The tissue sample should be submitted before or within 4 weeks after randomization; however, patients may be enrolled into the study before the pre-treatment tumor tissue sample is submitted
    - For women of childbearing potential: agreement to remain abstinent or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of study treatment
    - Men with female partners of childbearing potential or pregnant female partners must remain abstinent or use a condom during treatment with chemotherapy (i.e., carboplatin and etoposide) and for at least 6 months after the last dose of chemotherapy to avoid exposing the embryo
    - For patients enrolled in the extended China enrollment phase: current resident of mainland China, Hong Kong, or Taiwan and of Chinese ancestry
    E.4Principal exclusion criteria
    - Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
    - Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >=1 week prior to randomization
    - Leptomeningeal disease
    - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
    - Uncontrolled or symptomatic hypercalcaemia
    - Malignancies other than SCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS > 90%) treated with expected curative outcome
    - Women who are pregnant, lactating, or intending to become pregnant during the study
    - History of autoimmune disease
    - History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
    - Positive test for HIV
    - Active hepatitis B or hepatitis C
    - Active tuberculosis
    - Severe infections at the time of randomization, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia
    - Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina
    - Major surgical procedure other than for diagnosis within 28 days prior to randomization or anticipation of need for a major surgical procedure during the course of the study
    - Prior allogeneic bone marrow transplantation or solid organ transplant
    - Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk for treatment complications
    - Patients with illnesses or conditions that interfere with their capacity to understand, follow, and/or comply with study procedures
    - Treatment with any other investigational agent with therapeutic intent within 28 days prior to randomization
    - Administration of a live, attenuated vaccine within 4 weeks before randomization or anticipation that such a live attenuated vaccine will be required during the study
    - Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti−PD-1, and anti−PD-L1 therapeutic antibodies
    - Treatment with systemic immunosuppressive medications within 1 weeks prior to randomization
    - History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
    - Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
    - History of allergic reactions to carboplatin or etoposide
    E.5 End points
    E.5.1Primary end point(s)
    1. PFS
    2. OS
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-2. Up to 31 months
    E.5.2Secondary end point(s)
    1. Objective response
    2. DOR
    3. PFS rates at 6 months and at 1 year
    4. OS rates at 1 and 2 years
    5. TTD on each of the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) and EORTC Quality-of-Life Questionnaire Lung Cancer Module (QLQ-LC13) symptom subscales
    6. Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
    7. Changes in vital signs, physical findings, and clinical laboratory results
    8. Incidence of ATA response to Atezo and potential correlation with PK, pharmacodynamic, safety, and efficacy parameters
    9. Maximum observed serum Atezo concentration (Cmax)
    10. Minimum observed serum Atezo concentration (Cmin)
    11. Plasma concentrations for Carb
    12. Plasma concentrations for Etop
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-5. Up to 31 months
    6-7. Until 90 days after the last dose of study drug
    8. Cycle (C) 1 Day (D) 1, C2D1, C3D1, C4D1, C8D1, C16D1, after Cycle 16, Day 1 of every eighth cycle, at treatment discontinuation, 120 (+/- 30) days after last dose of Atezo
    9. C1D1, C2D1, C3D1, C4D1, C8D1, C16D1, after Cycle 16, Day 1 of every eighth cycle, at treatment discontinuation, 120 (+/- 30) days after last dose of Atezo
    10. C1D1, C2D1, C3D1, C4D1, C8D1, C16D1, after Cycle 16, Day 1 of every eighth cycle, at treatment discontinuation, 120 (+/- 30) days after last dose of Atezo
    11-12. C1D1, C3D1
    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 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) 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
    Efficacy data of the combination Atezo+Carboplatin+Etoposide for SLCC condition
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    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
    Australia
    Austria
    Bosnia and Herzegovina
    Chile
    China
    Czech Republic
    France
    Germany
    Greece
    Hong Kong
    Hungary
    Italy
    Korea, Republic of
    Mexico
    Poland
    Russian Federation
    Serbia
    Spain
    Taiwan
    United Kingdom
    United States
    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
    The end of study will occur when all of the following criteria have been met:
    *The LPLV has occurred (i.e., last patient in the global and extended China enrollment phases combined).
    *Approximately 306 deaths have been observed among the randomized patients in the global enrollment phase.
    *There are sufficient OS events in the ITT population enrolled in the China enrollment phase (see Section 6.1.1).
    Additionally, the Sponsor may decide to terminate the study at any time.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days1
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 350
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 206
    F.4.2.2In the whole clinical trial 500
    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)
    The Sponsor will evaluate the appropriateness of continuing to provide atezolizumab to patients assigned to this treatment after evaluating the primary and secondary efficacy outcome measures and safety data gathered in the study. These analyses may be conducted prior to completion of the study.
    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 Decision2016-06-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-07-07
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