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    Summary
    EudraCT Number:2019-004284-51
    Sponsor's Protocol Code Number:ESR-18-14159
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-04-14
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2019-004284-51
    A.3Full title of the trial
    An exploratory study of durvalumab (MEDI4736) uptake during concurrent chemoradiotherapy in stage III NSCLC patients using 89Zr-labeled durvalumab PET
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Does immunotherapy (durvalumab) accumulate in the tumors of patients with lung cancer receiving chemotherapy together with radiotherapy.
    A.3.2Name or abbreviated title of the trial where available
    CONDOR
    A.4.1Sponsor's protocol code numberESR-18-14159
    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 SponsorAmsterdam UMC, VU University Medical Center
    B.1.3.4CountryNetherlands
    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
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmsterdam UMC, VU University Medical Center
    B.5.2Functional name of contact pointIdris Bahce
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081HV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031204444782
    B.5.5Fax number0031204444328
    B.5.6E-maili.bahce@amsterdamumc.nl
    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
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Injection
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 Yes
    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
    Lung cancer, NSCLC
    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 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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Objective 1:
    To study durvalumab (MEDI4736) uptake in tumor and malignant lymph nodes longitudinally during cCRT (i.e. at baseline, shortly after start and after finishing cCRT)
    Hypothesis 1:
    Under cCRT, tumor cells will increase their PD-L1 expression, which will increase the uptake of MEDI4736 in tumorous lesions.

    Objective 2:
    To study early and late changes in durvalumab (MEDI4736) uptake in non-malignant lymph nodes and the spleen longitudinally during cCRT (i.e. at baseline, shortly after start and after finishing cCRT)
    Hypothesis 2:
    Under cCRT, immune cells will increase their PD-L1 expression, which will increase the uptake of MEDI4736 in lymphoid organs.
    E.2.2Secondary objectives of the trial
    Objective:
    To study the correlation between baseline tumor PD-L1 expression (based on immunohistochemistry) and 89Zr-durvalumab (89Zr-MEDI4736) uptake in tumorous lesions.
    Hypothesis:
    Tumor PD-L1 expression as determined in a single biopsy will be correlated to the uptake of 89Zr-MEDI4736 in that lesion, as measured by PET.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Have a histologically or cytologically confirmed diagnosis of thoracic disease stage III NSCLC and planned to receive concurrent chemotherapy and radiotherapy on the thorax.
    • Patients with oligometastatic stage IV comprising a thoracic stage III and up to 2 distant metastases amenable for radical local consolidative therapy are also eligible.
    • 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 obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
    • Age > 18 years at time of study entry.
    • Have a World Health Organisation (WHO) performance status of 0 or 1.
    • Life expectancy of > 3 months.
    • Have measurable disease based on RECIST 1.1.
    • Must consent to allow use of PD-L1 measurements obtained from tumor biopsies.
    • Adequate organ and bone marrow function, as deemed acceptable by the treating physician in the context of cCRT.
    • Females of childbearing potential must use reliable methods of contraception from the time of screening until 3 months after discontinuing study treatment. Acceptable methods of contraception include total sexual abstinence, tubal ligation, hormonal contraceptives that are not prone to drug-drug interactions, copper-banded intra-uterine devices and vasectomised partner. All methods of contraception must be used in combination with the use of a condom by their male sexual partners for intercourse.
    • Subject 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.
    E.4Principal exclusion criteria
    • Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study, or during the follow-up period of an interventional study.
    • Participation in another clinical study with an investigational product during the last 4 weeks.
    • Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) ≤ 30 days prior to the first dose of study drug If sufficient wash-out time has not occurred due to the schedule or PK properties of an agent, a longer wash-out period will be required, as agreed by AstraZeneca/MedImmune and the investigator.
    • Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, 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.
    • Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Limited surgical excision of isolated lesions for palliative or diagnostic reasons is acceptable.
    • History of allogenic organ transplantation.
    • 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]). The following are exceptions to this criterion:
    a. Patients with vitiligo or alopecia
    b. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
    c. Any chronic skin condition that does not require systemic therapy
    d. Patients without active disease in the last year may be included but only after consultation with the study physician
    e. Patients with celiac disease controlled by diet alone.
    • Active infection as judged to be unacceptable by the treating physician in the context of cCRT.
    • History of active primary immunodeficiency.
    • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
    a. Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
    b. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
    c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
    • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, 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.
    • History of another primary malignancy except for
    a. Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of IP and of low potential risk for recurrence
    b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
    c. Adequately treated carcinoma in situ without evidence of disease.
    • History of leptomeningeal carcinomatosis.
    • Patients with suspected brain metastases at screening should have an MRI (preferred) or CT each with IV contrast of the brain prior to study entry. Patients with more than 2 brain metastases will be excluded. Patients with 1 or 2 brain metastases that are not amenable for stereotactic radiotherapy will be excluded.
    • Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.
    • 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.
    • Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
    • Prior randomisation or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.
    • Any prior anti PD-1, PD-L1 and CTLA-4 therapy.
    E.5 End points
    E.5.1Primary end point(s)
    • To study early (1 week after start of cCRT) and late changes (after finishing cCRT) in durvalumab (MEDI4736) uptake in tumor and metastatic lymph nodes during cCRT
    • To study early and late changes in durvalumab (MEDI4736) uptake in immune related organs (i.e. non-malignant lymph nodes and spleen) during cCRT
    E.5.1.1Timepoint(s) of evaluation of this end point
    at the end of the study
    E.5.2Secondary end point(s)
    • To study any correlations between baseline tumor PD-L1 expression (based on immunohistochemistry) and the baseline uptake and changes in 89Zr-durvalumab (89Zr-MEDI4736) uptake in tumor sites.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the end of the study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    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 months
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state10
    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)
    Normal routine care
    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 Decision2020-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-06
    P. End of Trial
    P.End of Trial StatusCompleted
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