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    Summary
    EudraCT Number:2020-005537-32
    Sponsor's Protocol Code Number:D419QC00007
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-17
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2020-005537-32
    A.3Full title of the trial
    A Phase IIIb, Single-arm, Multi-center, International Study of Durvalumab in Combination with Platinum and Etoposide for the First Line Treatment of Patients with Extensive-stage Small Cell Lung Cancer (LUMINANCE)
    Jednoramenná multicentrická mezinárodní studie fáze IIIb hodnotící durvalumab v kombinaci s platinou a etoposidem v léčbě první linie u pacientů s malobuněčným karcinomem plic v pokročilém stádiu (LUMINANCE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An international study of durvalumab in combination with platinum and etoposide for the treatment of small cell lung cancer
    A.4.1Sponsor's protocol code numberD419QC00007
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressUSA
    B.5.3.2Town/ cityUSA
    B.5.3.3Post codeUSA
    B.5.3.4CountryUnited States
    B.5.6E-mailinformation.centre@astrazeneca.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 nameDurvalumab
    D.3.2Product code MEDI4736
    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 INNDurvalumab
    D.3.9.1CAS number 1428935-60-7
    D.3.9.2Current sponsor codeMEDI4736
    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 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
    Lung Cancer
    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
    To assess the safety and tolerability profile of durvalumab + EP treatment
    E.2.2Secondary objectives of the trial
    - To assess the efficacy of durvalumab + EP treatment
    - To further assess the safety and tolerability profile of durvalumab + EP, including all AEs
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
    2. Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.
    3. Provision of signed and dated written Genetic informed consent prior to collection of sample for genetic analysis.
    4. Age ≥ 18 years at the time of Screening.
    5. Histologically- or cytologically-documented ES-SCLC (stage IV [T any, N any, M1 a/b], or with T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan, according to American Joint Committee on Cancer Stage 8th edition).
    - Brain metastases; must be asymptomatic or treated and stable off steroids and anticonvulsants for at least 1 month prior to study treatment.
    6. Patients must be considered suitable to receive a platinum-based chemotherapy regimen as 1st line treatment for the ES-SCLC. Chemotherapy must contain either cisplatin or carboplatin in combination with etoposide.
    7. WHO/ ECOG Performance Status of 0 to 2 at enrollment.
    - Note: Patients with PS2 will be limited to a maximum of 30% of the total study
    population; once this limit is met, additional enrolled patients must have PS 0-1.
    8. Baseline computed tomography (CT) / magnetic resonance imaging (MRI) results of the brain, chest and abdomen (including liver and adrenal glands) within 28 days prior to the treatment initiation.
    9. No prior exposure to immune-mediated therapy including, but not limited to, other anti- CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.
    10. Adequate organ and marrow function as defined below:
    - Hemoglobin ≥ 9.0 g/dL.
    - Absolute neutrophil count ≥ 1.5 × 10^9/L (use of granulocyte colony-stimulating factor is not permitted at screening).
    - Platelet count ≥ 100 × 10^9/L.
    - Serum bilirubin ≤ 1.5 × the upper limit of normal (ULN).
    - In patients without hepatic metastasis: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN.
    - In patients with hepatic metastases, ALT and AST ≤ 5 × ULN.
    - Measured or calculated creatinine clearance: > 60 mL/min for patients planned to be treated with cisplatin and > 40 mL/min for patients planned to be treated with carboplatin as determined by Cockcroft-Gault:
    - Males: Creatinine CL = (Weight (kg) x (140 - age)) / (72 x serum creatinine (mg/dL))
    - Females: Creatinine CL = (Weight (kg) x (140 - age)) / (72 x serum creatinine (mg/dL)) x 0.85
    11. Life expectancy ≥ 12 weeks at Day 1.
    12. Body weight > 30 kg.
    13. Male and/or female
    14. 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. History of allogeneic organ transplantation.
    2. Active or prior documented autoimmune or inflammatory disorders. The following are exceptions to this criterion:
    - Patients with vitiligo or alopecia.
    - Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement.
    - Any chronic skin condition that does not require systemic therapy.
    - Patients without active disease in the last 5 years may be included but only after consultation with the Study Physician.
    - Patients with celiac disease controlled by diet alone.
    3. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease, serious chronic 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.
    4. History of another primary malignancy except for:
    - Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of IMP and of low potential risk for recurrence.
    - Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    - Adequately treated carcinoma in situ without evidence of disease.
    5. History of leptomeningeal carcinomatosis.
    6. History of active primary immunodeficiency.
    7. Active infection including tuberculosis, hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
    8. Any unresolved toxicity CTCAE Grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, lymphopenia and the laboratory values defined in the inclusion criteria:
    - Patients with Grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
    - Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.
    9. Known allergy or hypersensitivity to any of the study drugs or any of the study drug
    excipients.
    10. Received prior systemic therapy 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 ES-SCLC.
    11. Medical contraindication to platinum (cisplatin or carboplatin)-etoposide-based chemotherapy.
    12. Any concurrent chemotherapy, IMP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions is acceptable.
    13. Planned consolidation chest radiation therapy. Radiation therapy outside of the chest for palliative care is allowed but must be completed before first dose of the study medication.
    14. Receipt of live attenuated vaccine within 30 days prior to the first dose of IMP.
    15. Major surgical procedure within 28 days prior to the first dose of IMP.
    16. Patients who have received prior anti-PD-1 or anti PD-L1:
    - Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
    - All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.
    - Must not have experienced a Grade ≥ 3 immune-related AE or an immune-related neurologic or ocular AE of any grade while receiving prior immunotherapy.
    - Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of > 10 mg prednisone or equivalent per day.
    17. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
    - Intranasal, inhaled, topical steroids, or local steroid injections.
    - Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent.
    - Steroids as premedication for hypersensitivity reactions.
    18. Participation in another clinical study with an investigational product administered in the last 4 weeks.
    19. Concurrent enrolment in another clinical study, unless it is an observational clinical study or during the follow-up period of an interventional study.
    20. 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 90 days after the last dose of durvalumab.
    E.5 End points
    E.5.1Primary end point(s)
    - Incidence of Grade ≥ 3 AE
    - Incidence of imAEs
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis for safety will be conducted approximately 6 months after the last patient is enrolled into the study and the final statistical analysis will be conducted after the last patient had the opportunity to be followed up for a minimum of 12 months or 60% OS maturity, whichever occurs first.
    E.5.2Secondary end point(s)
    - PFS, ORR, DoR, DoR12, and PFS12 using site Investigator assessments according to RECIST 1.1
    - OS and OS12
    - Incidence of AEs, SAEs, AESIs, AE resulting in treatment discontinuation, and laboratory findings including clinical chemistry, hematology and urinalysis
    E.5.2.1Timepoint(s) of evaluation of this end point
    The primary analysis for safety will be conducted approximately 6 months after the last patient is enrolled into the study and the final statistical analysis will be conducted after the last patient had the opportunity to be followed up for a minimum of 12 months or 60% OS maturity, whichever occurs first.
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker assessment
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Canada
    Turkey
    Bulgaria
    Germany
    Italy
    United Kingdom
    Czechia
    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 years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 93
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 57
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 150
    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)
    In the event that a rollover or safety extension study is available at the time of the final data cut-off (DCO) and database closure, patients currently receiving treatment with durvalumab may be transitioned to such a study, and the current study would reach its end.
    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 Decision2021-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-11
    P. End of Trial
    P.End of Trial StatusOngoing
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