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    Summary
    EudraCT Number:2019-002192-33
    Sponsor's Protocol Code Number:TRADEhypo
    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:2019-10-24
    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 number2019-002192-33
    A.3Full title of the trial
    Thoracic Radiotherapy plus Durvalumab in Elderly and/or frail NSCLC stage III patients unfit for chemotherapy- Employing optimized (hypofractionated) radiotherapy to foster durvalumab efficacy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Thoracic Radiotherapy plus Durvalumab in Elderly and/or frail NSCLC stage III patients unfit for chemotherapy- Employing optimized (hypofractionated) radiotherapy to foster durvalumab efficacy
    A.3.2Name or abbreviated title of the trial where available
    TRADE-hypo
    A.4.1Sponsor's protocol code numberTRADEhypo
    A.5.4Other Identifiers
    Name:AstraZeneca Code Number:ESR-18-13893
    Name:AIO Study NumberNumber:AIO-YMO/TRK-0319
    Name:IKF Trial IDNumber:IKF-t020
    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 SponsorFrankfurter Institut für Klinische Krebsforschung IKF GmbH
    B.1.3.4CountryGermany
    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 supportAstraZeneca GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFrankfurter Institut für Klinische Krebsforschung IKF GmbH
    B.5.2Functional name of contact pointIKF
    B.5.3 Address:
    B.5.3.1Street AddressSteinbacher Hohl 2-26
    B.5.3.2Town/ cityFrankfurt am Main
    B.5.3.3Post code60488
    B.5.3.4CountryGermany
    B.5.4Telephone number+496976014420
    B.5.5Fax number+496976013655
    B.5.6E-mailriedel.johanna@ikf-khnw.de
    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 Imfinzi
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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 nameDurvalumab
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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
    unresectable stage III NSCLC (Non–small-cell lung cancer)
    E.1.1.1Medical condition in easily understood language
    unresectable stage III NSCLC (Non–small-cell 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 10029519
    E.1.2Term Non-small cell lung cancer stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10029520
    E.1.2Term Non-small cell lung cancer stage IIIA
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025052
    E.1.2Term Lung cancer non-small cell stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025054
    E.1.2Term Lung cancer non-small cell stage IIIB
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025053
    E.1.2Term Lung cancer non-small cell stage IIIA
    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 safety and tolerability of either conventionally fractionated (CON-group) or hypofractionated (HYPO-group) thoracic radiotherapy in combination with durvalumab.

    Primary efficacy objective
    To investigate the efficacies of either mode of fractionation of radiotherapy in combination with durvalumab with respect to the response rates in patients with unresectable stage III NSCLC, who are not suitable for chemotherapy.
    E.2.2Secondary objectives of the trial
    To determine further parameters for efficacy, safety, and quality of life in both treatment arms.

    Exploratory objectives
    Vulnerability assessment is based on the G8-screening questionnaire. We choose G8 as our screening tool because it is a simple and fast screening tool with great potential for identifying patients with a geriatric risk profile and it has a strong prognostic value for functional decline and OS in an older population with cancer (Kenis et al., 2014).
    Collection of tumor tissue, blood and stool samples for separate biomarker research project.
    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 documented diagnosis of unresectable stage III NSCLC.
    4. Non-feasibility of sequential chemo-/radiotherapy as determined by the site’s multi-disciplinary tumor board; If there is no tumor board, then this decision will be made by the investigator in consultation with a radiation oncologist, if the investigator is not a radiation oncologist; or by the investigator in consultation with an oncologist, if the investigator is not an oncologist.
    5. Fulfills at least one of the following criteria:
    • Performance status (PS) 2 (ECOG scale)
    • ECOG 1 and CCI ≥ 1
    • Age ≥ 70 years
    6. Must have a life expectancy of at least 12 weeks.
    7. FEV1 ≥ 40% (Best/Soll)
    8. DLCO or DLCO/VA (Hb-corrected, if available) ≥ 40% (Best/Soll)
    9. FVC or VC ≥ 70% (Best/Soll)
    10. At least one measurable site of disease as defined by RECIST 1.1 criteria.
    11. Adequate bone marrow and renal function including the following:
    o Hemoglobin ≥ 9.0 g/dL;
    o absolute neutrophil count ≥ 1.0 x 10^9/L;
    o platelets ≥75x 10^9/L;
    o Calculated creatinine clearance ≥30 mL/min as determined by the Cockcroft-Gault equation
    12. Adequate hepatic function (with stenting for any obstruction, if required) including the following:
    o Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN);
    o AST (SGOT) / ALT (SGPT) ≤ 2.5x institutional ULN
    13. Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.
    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:
    o 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).
    o 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).
    15. 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.
    E.4Principal exclusion criteria
    1. 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.
    2. Participation in another clinical study with an investigational product within 21 days prior to the first dose of the study treatment.
    3. Prior immunotherapy or use of other investigational agents, including anti-PD-1, anti-PD-L1, including durvalumab, anti-PD-L2, or anti-CTLA-4 antibody, therapeutic cancer vaccines.
    4. History or current radiology suggestive of interstitial lung disease.
    5. Oxygen-dependent medical condition.
    6. Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer related conditions (e.g., hormone replacement therapy) is acceptable.
    7. Prior thoracic radiotherapy within the past 5 years before the first dose of study drug.
    8. Major surgery within 4 weeks prior to enrollment into the study; patients must have recovered from effects of any major surgery.
    9. Active or prior documented autoimmune or inflammatory disorders (except inflammatory bowel disease [e.g. ulcerative colitis or Crohn's disease]; (including 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: Patients with vitiligo or alopecia, Patients with hypothyroidism (e.g., following Hashimoto’s disease) 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
    10. 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.
    11. 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.
    12. History of another primary malignancy except for: Malignancy treated with curative intent and with no known active disease ≥ 3 years before the first dose of IP 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
    13. History of leptomeningeal carcinomatosis
    14. History of active primary immunodeficiency
    15. History of allogenic organ or tissue transplantation.
    16. Clinical diagnosis of active tuberculosis.
    17. Positive testing for HBV sAg or HCV RNA indicating acute or chronic infection. Patients with a past or resolved HBV infection (defined as the presence of anti-HBc and absence of HBsAg) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
    18. Positive testing for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
    19. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
    o Intranasal, inhaled, topical steroids, or local steroid injections
    o Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
    o Steroids as premedication for hypersensitivity reactions
    20. Receipt of live attenuated vaccine within 30 days prior to the first dose of IMP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IMP and up to 30 days after the last dose of IMP.
    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 180 days after the last dose of durvalumab monotherapy.
    22. Known allergy or hypersensitivity to any of the IMPs or any of the constituents of the product.
    23. Any co-existing medical condition that in the investigator’s judgement will substantially increase the risk associated with the patient’s participation in the study.
    24. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities.
    25. Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts.
    E.5 End points
    E.5.1Primary end point(s)
    Toxicity, defined by the occurence of treatment-related pneumonitis grade ≥3.

    Primary efficacy endpoint:
    Objective response according to RECIST 1.1 criteria
    E.5.1.1Timepoint(s) of evaluation of this end point
    A safety interim assessment based on the primary safety endpoint, occurrence of a grade 3/4 pneumonitis, is conducted after 18 patients have been enrolled into the HYPO-group.

    An interim efficacy analysis based on the objective response rate (ORR) will be conducted after n=18
    response-evaluable patients in each arm. The response-evaluable population is defined as all enrolled patients who started TRT, received at least one dose of durvalumab and provided at least one post-baseline response assessment. The response-evaluable population will be used as the primary population for the analysis of the primary efficacy endpoint ORR.

    Final analysis will be done after LPLV / at end of trial.
    E.5.2Secondary end point(s)
    • Occurence of treatment-related AEs and SAEs according to CTCAE V5.0
    • Abnormal values of laboratory parameters
    • PFS according to RECIST 1.1
    • Duration of Clinical Benefit (Duration of CR, PR, SD) according to RECIST 1.1
    • MFS
    • OS
    • QoL (FACT-L)
    • Descriptive sub-group analyses of efficacy in relation to PD-L1 expression levels (<°1% vs ≥°1%)

    Exploratory endpoints:
    • Vulnerability assessment based on the G8-screening questionnaire and its association to survival and outcome
    • Collection of blood- and stool based biomarker samples for future research

    E.5.2.1Timepoint(s) of evaluation of this end point
    Regarding the safety parameters: A safety interim assessment is conducted after 18 patients have been enrolled to the HYPO-group.

    Final analysis will be done after LPLV / at end of trial.
    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
    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 concerned20
    E.8.5The trial involves multiple Member States No
    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
    LPLV
    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 months11
    E.8.9.1In the Member State concerned 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: 19
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    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 state57
    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 investigators of the study are experienced medical or surgical oncologists who treat patients in routine clinical practice. Therefore, the investigators are responsible for the further treatment of the patient after the end of the study treatment for disease progression. The investigators shall support and advice the patient and – if required – help to organize appointments with other specialized physicians.
    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 Decision2020-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-06
    P. End of Trial
    P.End of Trial StatusOngoing
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