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    Summary
    EudraCT Number:2017-004572-62
    Sponsor's Protocol Code Number:MO40379-ACHILES-2017-12
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-06-27
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2017-004572-62
    A.3Full title of the trial
    A randomized phase II study comparing atezolizumab after concurrent chemo-radiotherapy with chemo-radiotherapy alone in limited disease small-cell lung cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A comparative trial of either immunotherapy after combined chemo-radiotheraphy, or chemo-radoptherapy alone for patients with limited disease small-cell lung cancer
    A.3.2Name or abbreviated title of the trial where available
    ACHILES
    A.4.1Sponsor's protocol code numberMO40379-ACHILES-2017-12
    A.5.4Other Identifiers
    Name:Clinical trials IDNumber: 2017-11-03BHG
    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 SponsorNorwegian University of Science and Technology, Department of Clinical and molecular medicine
    B.1.3.4CountryNorway
    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 supportF.Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportNorwegian University of Science and Technology
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNTNU
    B.5.2Functional name of contact pointStudy coordinator
    B.5.3 Address:
    B.5.3.1Street AddressNTNU, Post box 8905 MTFS
    B.5.3.2Town/ cityTrondheim
    B.5.3.3Post code7491
    B.5.3.4CountryNorway
    B.5.4Telephone number+4772828142
    B.5.6E-mailinger.storaker@ntnu.no
    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 Tecentriq
    D.2.1.1.2Name of the Marketing Authorisation holderF.Hoffmann-La Roche Ltd.
    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.3.1Product nameAtezolizumab
    D.3.2Product code RO5541267/F03
    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.3.9.1CAS number 1380723-44-3
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameMPDL3280A, Tecentriq
    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 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
    Limited disease small-cell lung cancer
    E.1.1.1Medical condition in easily understood language
    Inoperable small-cell lung cancer if all lesions can be included in a tolerable radiotherapy field; i.e. confined to one hemithorax plus mediastinal, hilar and supraclavicular lymph nodes
    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 10041069
    E.1.2Term Small cell lung cancer limited 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 investigate whether adjuvant atezolizumab treatment after standard, concurrent chemo-radiotherapy improves survival in limited disease small-cell lung cancer patients - as compared to chemo-radiotherapy alone.
    E.2.2Secondary objectives of the trial
    To investigate whether immunotherapy improves efficacy with respect to best response rates, progression free survival and symptom relief. To compare the frequency and severity of side effects, and patient-reported quality of life. To characterize the patients who benefit the most from the treatment with respect to clinical characteristics, tissue, blood and urine biomarkers.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The exploratory analyses will be conducted as a substudy. Due to the rapid development of knowledge and technology within this field, we will outline a detailed project plan when the last patient has been enrolled. We expect to the complete this subproject within 5 years of enrollment of the last patient.
    E.3Principal inclusion criteria
    1. Histologically or cytologically confirmed small-cell lung cancer
    2. No prior systemic therapy for SCLC or immune checkpoint blockade therapy
    3. Previous radiotherapy to the thorax is allowed as long as the patient can receive TRT of 45 Gy. If it later turns out that 45 Gy cannot be administered, the patient should be excluded.
    4. Stage I-III according to TNM v8 ineligible for surgery provided all lesions can be included in a tolerable radiotherapy field (“limited disease”)
    5. Age ≥ 18 years
    6. ECOG performance status 0-2
    7. Measureable disease according to the RECIST 1.1
    8. Adequate organ function defined as:
    a. Serum alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN)
    b. Total serum bilirubin ≤ 1.5 x ULN
    c. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    d. Platelets ≥ 100 x 109/L
    e. Creatinine < 100 µmol/L and calculated creatinine-clearance > 50 ml/min. If calculated creatinine-clearance is < 50 ml/min, an EDTA clearance should be performed.
    9. No malignant cells in pericardial or pleural fluid (at least 1 sample should be obtained if pleural fluid is present) If there is so little fluid that it cannot easily be collected, the patient is considered eligible.
    10. Pulmonary function: FEV1 > 1 l or > 30 % of predicted value and DLCO > 30 % of predicted value
    11. All fertile patients should use safe contraception
    12. Written informed consent
    E.4Principal exclusion criteria
    11. Any serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) that in the opinion of the investigator would compromise the patient’s ability to complete the study or interfere with the evaluation of the efficacy and safety of the study treatment
    12. Any autoimmune or lung disease requiring systemic steroids in doses of >10 mg prednisolone (or equivalent dose of other steroid)
    13. Any previous allogeneic or organ transplant
    14. Any active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis
    15. Any history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
    16. Any live vaccine last 30 days, active infection requiring IV antibiotics, no active viral hepatitis or HIV-positive
    17. Any conditions – medical, social, psychological – which could prevent adequate information and follow-up
    18. Any clinically active cancer other than SCLC with the exception of malignancies with a negligible risk of metastases or death (e.g. 5-years OS rate of >90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer. Hormonal therapy for non-metastatic prostate or breast cancer is allowed.
    19. Pregnancy or lactating women
    E.5 End points
    E.5.1Primary end point(s)
    2-year survival
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years after last patient has been enrolled in the trial
    E.5.2Secondary end point(s)
    - Best response rate
    - Progression free survival
    - Overall survival
    - Toxicity

    Exploratory analyses:
    - Prognostic and predictive role of clinical characteristics, tissue, blood and urine biomarkers in relation to the primary and secondary endpoints
    E.5.2.1Timepoint(s) of evaluation of this end point
    The best response rates, progression free survival, toxicity, and health related quality of life will be reported within two years after enrollment of the last patient. The final survival analyses will be completed 5 years after enrollment of the last patient. By that time, we expect that also the exploratory analyses will be completed.
    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 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.8.2.3.1Comparator description
    Observation
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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 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
    According to the trial design, the study treatment will continue for a maximum of 12 months after chemo-radiotherapy for patients randomized to the experimental arm. Data collection will be completed 5 years after enrollment of the last patient. Studies show that immunotherapy might provide long term survival in some patients. Thus, 5 year survival is an endpoint of great interest. The exploratory analyses will start after enrollment is completed and is expected to take several years.

    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months6
    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: 106
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 106
    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 state110
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 212
    F.4.2.2In the whole clinical trial 212
    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
    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 Decision2018-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-24
    P. End of Trial
    P.End of Trial StatusOngoing
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