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    EudraCT Number:2019-000058-77
    Sponsor's Protocol Code Number:ESPADURVA
    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:2019-08-29
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2019-000058-77
    A.3Full title of the trial
    Prospective Phase-II Trial of induction chemotherapy and chemoradiotherapy plus/minus the PD-L1 antibody durvalumab followed by surgery or definitive chemoradiation boost and consolidation durvalumab in resectable stage III NSCLC
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of two treatment arms of patients with non-small cell lung cancer. Patients of one arm receive the authorized infusion Durvalumab after chemotherapy, chemotherapy with radiotherapy and optional resection. Patients in the second treatment arm receive Durvalumab from the beginning, in parallel with standard therapy.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberESPADURVA
    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 SponsorUniversity Hospital Essen
    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 supportAstra Zeneca
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsmedizin Essen - Studienzentrum GmbH
    B.5.2Functional name of contact pointStudy Coordination
    B.5.3 Address:
    B.5.3.1Street AddressHufelandstraße 55
    B.5.3.2Town/ cityEssen
    B.5.3.3Post code45147
    B.5.4Telephone number+49020172377412
    B.5.5Fax number+4902017239477412
    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 IMFINZI®
    D. 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.3.2Product 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.3.9.3Other descriptive nameMEDI4736
    D.3.9.4EV Substance CodeSUB176342
    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. 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 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
    non-small cell lung cancer stages IIIA (N2) and selected resectable stages IIIB
    E.1.1.1Medical condition in easily understood language
    Lung cancer, stages IIIA and IIIB
    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 10061873
    E.1.2Term Non-small cell lung cancer
    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 primary objective is to assess the efficacy of a multimodality treatment in resectable stage III non-small-cell lung cancer patients including a complex induction chemoimmunotherapy followed by a radiochemoimmunotherapy and definitive surgical resection or radiochemotherapy-boost and immunotherapy consolidation for 32 weeks versus the same multimodality treatment protocol without immunotherapy in the induction and radiochemotherapy as measured by two-year progression-free survival.
    E.2.2Secondary objectives of the trial
    The secondary objective is to analyze the toxicity and efficacy of a multimodality treatment in resectable stage III non-small-cell lung cancer patients including a complex induction chemoimmunotherapy followed by a radiochemoimmunotherapy and definitive surgical resection or radiochemotherapy-boost and immunotherapy consolidation for 32 weeks versus the same multimodality treatment protocol without immunotherapy in the induction and radiochemotherapy as measured by response, survival parameters, QoL, compliance and treatment toxicity effects. The secondary objective will be will be achieved by the following secondary endpoints:
    • To investigate the rate of pathological complete response
    • To investigate the toxicity and the following surgical resection
    • To investigate 2-y-overall survival rate
    • To investigate functional and RECIST response
    • Progression free survival time
    • Overall survival
    • Histopathologic complete response
    • Other adverse events
    • Quality of life
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Translational Research Project
    E.3Principal inclusion criteria
    1. Body weight >30 kg
    2. Age ≥ 18 years and ≤ 75 years
    3. Male or female patients. Female (as well as male) patients have to take care of effective measures of anticonception
    4. Histologically proven non-small cell lung cancer
    5. Selected patients with non-small cell lung cancer stages IIIA and IIIB:
    • IIIA: one or more lymph node levels involved at EBUS/mediastinoscopy
    • IIIA: bulky N2-disease histologically proven at EBUS/cervical mediastinoscopy / parasternal mediastinotomy, not diffuse mediastinal involvement
    • selected IIIB: N3-disease with contralateral mediastinal nodes involved at EBUS / mediastinoscopy
    • potentially resectable T4-disease:
    o involvement of the pulmonary artery (angiogr.-CT/MRI/TEE),
    o involvement of the carina (histologically proven),
    o involvement of the left atrium (angiogr.-CT/MRI/TEE),
    o involvement of the vena cava (angiogr.-CT/MRI/TEE),
    o involvement of ipsilateral intrapulmonary satellite nodules,
    o mediastinal involvement (not diffuse)
    6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    7. Resectable disease at the time of inclusion
    8. Fulfillment of adequate criteria for functional and medical resectability as described in the ERS/ESTS guidelines [Brunelli et al 2009] and acceptable general clinical condition for multimodality treatment (interdisciplinary committee)
    9. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (e.g, 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
    10. Must have a life expectancy of > 12 weeks
    11. Adequate normal organ and marrow function as defined below:
    o Haemoglobin ≥ 9.0 g/dL
    o Absolute neutrophil count (ANC) > 1.5 x 109/L (> 1500 per mm3)
    o Platelet count ≥ 100 x 109/L (≥ 100.000 per mm3)
    o Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
    o AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal
    o Measured creatinine clearance (CL) > 40 mL/min or Calculated creatinine
    CL > 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
    12. 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
    13. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
    14. Stable cardiac function (no Myocardial infarction (MI) within 6 months, no heart failure NYHA III-IV)
    E.4Principal exclusion criteria
    1. resectable IIB or selected IIIA
    2. unresectable disease pre-treatment
    3. mixed histology with areas of small cell carcinoma
    4. clinically symptomatic vena cava superior syndrome
    5. diffuse mediastinal involvement
    6. patients with T3N3 and T4N3 tumors
    7. invasion of the thoracic aorta
    8. invasion of the heart
    9. invasion of the esophagus
    10. invasion of spine
    11. Pancoast-syndrome in tumors of the superior sulcus
    12. malignant pericardial effusion
    13. malignant pleural effusion
    14. involvement of the contralateral hilar nodes
    15. endobronchial tumor extension to the contralateral main stem bronchus
    16. ipsi- or contralateral supraclavicular nodes
    17. lung or heart function not allowing at the time of inclusion the intended surgical procedure
    18. previous administration of chemotherapy and/or radiotherapy
    19. previous immunotherapy
    20. insufficient patients compliance
    21. loss of weight > 10 % in the last six months
    22. missing written informed consent or definitive refusal for participation
    23. Participation in another clinical study with an investigational product during the last 12 months
    24. Concurrent enrolment in another clinical study, unless it is an observational clinical study or during the follow-up period of an interventional study
    25. 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
    26. History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan
    27. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions is acceptable
    28. Major surgical procedure within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable
    29. History of allogenic organ transplantation
    30. History of a stem cell transplantation
    31. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]).
    32. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled diabetes, cardiac arrhythmia, 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
    33. History of another primary malignancy
    34. History of active primary immunodeficiency
    35. Active infection including tuberculosis hepatitis B, hepatitis C, or human immunodeficiency virus. Patients with a past or resolved HBV infection are eligible. Patients positive for hepatitis C antibody are eligible only if polymerase chain reaction is negative for HCV RNA
    36. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
    37. Current or prior use of immunostimulatory agents within 14 days before the first dose of durvalumab
    38. Receipt of live attenuated vaccine within 90 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 90 days after the last dose of IP
    39. 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 monotherapy
    40. Known allergy or hypersensitivity to durvalumab or any excipient

    For full text exclusion criteria and exceptions please refer to study protocol section 4.2
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the progression-free survival rate

    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be analyzed after the end of 2 year follow-up of the last treated patient. The observed proportion will be compared with the expected proportion of 35% using the exact binominal test.
    If the observed proportion is significantly larger than 0.35 using a one sided exact binominal test at alpha=0.025, than the gate is opened for a second comparison in fixed sequence as step 2. Here, PFS data from both treatment arms will be compared by a log rank test as sequentially rejective Bonferroni-type test . The power is 80% to detect a HR of ≤ 0.5 between Arm B and Arm A at a significance level of alpha = 0.05 having 84 evaluable patients.
    E.5.2Secondary end point(s)
    - Overall survival
    - Occurrence of pulmonary adverse effects of grade > 3 according to CTCAE 5.0.
    - Occurrence of immune therapy related adverse effects of grade > 3 according to CTCAE v.5.0.
    - Adverse events with at least probable relationship to study procedures will counted in total and separate according to CTCAE criteria.
    - Quality of life (QoL C30 and Qol-LC13) date will be analyzed descriptively calculation mean scores, standard deviations median minimum and maximum of the scores.
    See also section
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Overall survival: Median survival time and survival rates after 1, 2, 3, and 4 years will be estimated together with 95% confidence limits.
    - All other secondary endpoints will be analyzed after the end of 2 year follow-up of the last treated patient.
    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. 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
    Control group receive durvalumab after chemotherapy and chemoradiotherapy
    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 concerned7
    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 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
    Last patient last 2 year after randomisation Follow-up visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state90
    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)
    Following the end of treatment evaluation or the end of study for any other cause, patients will be treated and followed according to the guidelines of the German Cancer Society.
    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 Decision2019-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-04
    P. End of Trial
    P.End of Trial StatusOngoing
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