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    Summary
    EudraCT Number:2008-002130-30
    Sponsor's Protocol Code Number:NSCLC-TKD/IL-2
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-06-09
    Trial results View 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 number2008-002130-30
    A.3Full title of the trial
    Targeted Natural Killer (NK) cell based adoptive immunotherapy for the treatment of patients with Non-Small Cell Lung Cancer (NSCLC) after radiochemotherapy (RCT)
    Zielgerichtete, adjuvante Immuntherapie mittels aktivierter NK-Zellen bei Patienten mit einem nichtkleinzelligen Bronchialkarzinom (NSCLC) im Anschluss an Radiochemotherapie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Targeted Natural Killer (NK) cell based adoptive immunotherapy for the treatment of patients with Non-Small Cell Lung Cancer (NSCLC) after radiochemotherapy (RCT)
    Zielgerichtete, adjuvante Immuntherapie mittels aktivierter NK-Zellen bei Patienten mit einem nichtkleinzelligen Bronchialkarzinom (NSCLC) im Anschluss an Radiochemotherapie
    A.3.2Name or abbreviated title of the trial where available
    NK Immuntherapie
    A.4.1Sponsor's protocol code numberNSCLC-TKD/IL-2
    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 SponsorTechnische Universität München Fakultät für Medizin
    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 supportBundesministerium für Bildung und Forschung
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMünchner Studienzentrum
    B.5.2Functional name of contact pointBeate Schossow
    B.5.3 Address:
    B.5.3.1Street AddressIsmaningerstr 22
    B.5.3.2Town/ cityMünchen
    B.5.3.3Post code81675
    B.5.3.4CountryGermany
    B.5.4Telephone number0049(0)8941405840
    B.5.5Fax number0049(0)8941406322
    B.5.6E-mailbeate.schossow@mri.tum.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 No
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameTKD_NK
    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.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typenot less then
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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 Yes
    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
    Interventional phase II clinical trial incorporating a parallel control group of patients receiving no adjuvant immunotherapy. Patients with non small lung cell carcinoma (NSCLC) in stage III A and III B who had no radiochemotherapy before will be enrolled into the phase II clinical trial. The aim of the study is to show the efficacy of an adjuvant treatment with Hsp70-peptide TKD/IL-2 activated, autologous NK cells following completion of standard radiochemotherapy (Cisplatin/Vinorelbine).
    interventionelle, klinische Phase II Studie die neben dem Prüfarm einen Kontrollarm ohne adjuvante Immuntherapie beinhaltet. Eingeschlossen werden Patienten mit einem histologisch gesicherten Bronchialkarzinom (NSCLC) im lokal fortgeschrittenen Stadium (Stadien IIIA und IIIB) nach Abschluss einer Radiochemotherapie (60-66Gy/Vinorelbine+Cisplatin). Das Ziel der Studie ist die Effektivität einer adjuvanten Immuntherapie mit aktivierten NK-Zellen zu überprüfen.
    E.1.1.1Medical condition in easily understood language
    Interventional phase II clinical Patients with non small lung cell carcinoma in stage III A and III B.
    interventionelle, klinische Phase II Studie Eingeschlossen werden Patienten mit einem histologisch gesicherten Bronchialkarzinom (Stadien IIIA und IIIB)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10006427
    E.1.2Term Bronchial carcinoma stage III
    E.1.2System Organ Class 100000004864
    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 of this study is to examine whether an adjuvant treatment with TKD/IL-2-activated, patient-derived NK cells following definitive RCT is feasible and effective. Comparison of progression-free survival between treatment and control group A control arm with standard radiochemotherapy (Cisplatin/Vinorelbine) is part of this study, because Pfister et al (2007) could demonstrate that lung cancer patients with an Hsp70 membrane expression had a poorer clinical outcome with respect to overall survival when compared to their Hsp70 membrane counterparts. Therefore, all historic data on overall survival of lung cancer patients are the result of a mixture of Hsp70 positive and negative patients and median overall survival of Hsp70 positive lung cancer patients is not known.
    E.2.2Secondary objectives of the trial
    To evaluate response to the treatment, toxicity, quality of life (LCSS), increase of overall survival and to determine biological parameters such as NK cell activation. Safety will be assessed according to NCI-CTC criteria.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. First diagnose of histologically and/or cytologically proven and unresectable NSCLC with clinically stage III A and III B
    2. Completion of radiochemotherapy no longer than 8 weeks ago
    3. Progression free according to RECIST 1.1 criteria at the first assessment after completion of radiochemotherapy
    4. Confirmed presence of Hsp70 on patient´s tumors
    5. Female or male, age 18 to 75 years
    6. ECOG Status ≤ 2
    7. Neutrophil count ≥ 1.5 x 109/l after completion of radiochemotherapy
    8. WBC ≥ 2.5 x 109/l after completion of radiochemotherapy
    9. Haemoglobin >8g/l after completion of radiochemotherapy
    10. Platelet count ≥ 100 x 109/l after completion of radiochemotherapy
    11. Normal renal function (creatinine <150% ULN)
    12. Normal liver function (Bilirubin <200% ULN; G-GT, GPT und GOT <250% ULN;)
    13. Normal blood coagulation (PTT 25-40s)
    14. Measurable disease according to irRC criteria
    15. Female patients of childbearing potential must have negative pregnancy test performed during screening period (≤ 14 days before initiation of study drug dosing). Postmenopausal women must be amenorrheal for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study and for 6 months following discontinuation of study drug.
    16. Written (signed) Informed Consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment and to participate in the study
    17. Ability to comply with study and follow-up procedures
    E.4Principal exclusion criteria
    1. Prior treatment with any other investigational drug within 4 weeks prior to first dose of study medication
    2. Any severe heart disease or any severe concomitant disease (ECOG stage > 2)
    3. NSCLC patients (stage IIIA/B) eligible for initial surgery with a confirmed consent of an interdiscipliary Tumorboard
    4. Patients that show ALK positivity or an activating mutation of the EGFR-TK domain
    5. Patients with locally advanced or metastastic non-small cell lung cancer other than predominantly squamous cell histology
    6. Any disease (including psychotic disorders, drug abuse, active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding likely (in the investigator’s opinion) to affect the evaluation of the study or place the patient at risk whilst on treatment
    7. Any serious infection or sepsis
    8. Any active autoimmune disease
    9. Any immunodeficiency syndrome
    10. Surgery or immunotherapy within 4 weeks before study entry
    11. Patients with known hypersensitivity to any of the administered substances should be excluded from the clinical trial
    12. Patients with a positive HIV test should be excluded from the clinical trial as well as patients with positive Hepatitis A, B, C tests
    13. Receipt of immunosuppressive drugs including high dose systemic corticosteroids within 3 weeks before study entry. Low dose corticosteroids as they are a common treatment option for patients suffering from COPD are not an exclusion criterium.
    14. Radio-, cytostatic-, and immuno-therapy in parallel or within 4 weeks prior to study start
    15. Women who are pregnant or breast feeding
    16. Female patients of reproductive potential unwilling to practice a highly effective method of birth control
    17. History of noncompliance with medical regimens
    18. Patients unwilling to or unable to comply with the protocol
    E.5 End points
    E.5.1Primary end point(s)
    - Progression free survival (PFS)
    E.5.2Secondary end point(s)
    - Response, toxicity, Quality of life (LCSS), Patients overall survival and NK activation

    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 No
    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 No
    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 No
    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 concerned3
    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
    November 2018
    LPLV 05 2020
    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 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: 90
    F.1.3Elderly (>=65 years) No
    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 state90
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 90
    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)
    Nein
    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 Decision2013-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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