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    Summary
    EudraCT Number:2014-005595-28
    Sponsor's Protocol Code Number:AIO-TRK-0214
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-07-20
    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 - BfArM
    A.2EudraCT number2014-005595-28
    A.3Full title of the trial
    Induction therapy with gefitinib followed by taxane platinum chemotherapy and intercalated gefitinib in NSCLC stages II-IIIB with activating EGFR mutation – A single arm Phase II trial.
    Einleitungstherapie mit Gefitinib gefolgt von einer Taxan-Platin-Chemotherapie mit Verabreichung von Gefitinib bei nicht-kleinzelligem Lungenkarzinom Stadium II-IIIb mit aktivierenden EGFR Mutationen - eine einarmige Phase II Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Therapy with gefitinib followed by conventional chemotherapy in certain tumor patients.
    Therapie mit Gefitinib gefolgt von einer konventionellen Chemotherapie in bestimmten Tumorpatienten.
    A.3.2Name or abbreviated title of the trial where available
    NeoIntercal
    A.4.1Sponsor's protocol code numberAIO-TRK-0214
    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 SponsorAIO-Studien-gGmbH
    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 organisationAIO-Studien-gGmbH
    B.5.2Functional name of contact pointDr. Aysun Karatas
    B.5.3 Address:
    B.5.3.1Street AddressKuno-Fischer-Str. 8
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code14057
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930814534431
    B.5.5Fax number+4930322932926
    B.5.6E-mailinfo@aio-studien-ggmbh.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 IRESSA
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGEFITINIB
    D.3.9.1CAS number 184475-35-2
    D.3.9.4EV Substance CodeSUB20637
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 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 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
    Patients with stage II, IIIA and IIIB non-squamous non-small-cell lung cancer with activating EGFR mutation
    E.1.1.1Medical condition in easily understood language
    Patients with non-squamous 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 19.0
    E.1.2Level PT
    E.1.2Classification code 10073254
    E.1.2Term Neoadjuvant therapy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    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 the study is to assess the pathologic complete remission rate (according to the Junker criteria regression IIB and III) after induction therapy with gefitinib D-12 to D -1 followed by docetaxel 75 mg/m2 and cisplatin 50 mg/m2 D1+2 q21d (or paclitaxel 200 mg/m² D1 and carboplatin AUC 6.0 D1) and intercalated gefitinib 250 mg D4 to D20 (cycles 1 + 2) and D4-D17 (cycle 3) in mediastinal/hilar lymph nodes as well as primary tumor.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:

    • To assess the safety and tolerability of induction CTx with docetaxel and cisplatin in combination with gefitinib

    • To assess the R0 resection rate

    • To assess the radiologic response based on CT

    • To assess the progression free survival (PFS)

    • To assess the overall survival (OS)

    • To assess the relapse pattern

    • To assess the QoL during and after induction therapy with gefitinib, after three cycles of chemotherapy with intercalated gefitinib and after surgery.

    • Liquid biopsy project: Analysis of EGFR ctDNA in patient plasma; screening for EGFR mutation status (activating and resistance mutations especially T790M)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with histologically or cytologically confirmed non-squamous non-small-cell lung cancer (NSCLC) stage II, IIIA and IIIB detected preoperatively by adequate methods and activating EGFR mutation in exons 18-21. Stage should be confirmed by PET-CT as well as adequate mediastinal staging. Routine MRI of the brain to exclude CNS-metastases is mandatory before enrolment according to standard guidelines.

    2. At least one unidimensionally measurable lesion meeting RECIST criteria (version 1.1)

    3. Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale

    4. Estimated life expectancy of at least 12 weeks

    5. Patients aged ≥ 18 years

    6. Adequate organ function including the following:

    a) Adequate bone marrow reserve:
    – absolute neutrophils (segmented and bands) count (ANC) ≥1.5x10e9/L;
    – platelets ≥100x10e9/L;
    – haemoglobin ≥9 g/dL.

    b) Hepatic:
    – bilirubin ≤ 1xULN;
    – alkaline phosphatase (AP) ≤ 2.5xULN;
    – aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5xULN.

    c) Renal:
    – serum creatinine ≤ 1.3 mg/dL;
    – glomerular filtration rate ≥ 70 mL/min (calculated) for cisplatinum based CTx. If contraindications including GFR below 70mL/min against cisplatin exist, carboplatin may also be used.
    - glomerular filtration rate ≥ 30 mL/min (calculated) if carboplatin is to be used

    7. Cooperation and willingness to complete all aspects of the study

    8. Written informed consent to participate in the study
    E.4Principal exclusion criteria
    1. EGFR wild type configuration

    2. EGFR resistance mutations (i.e. T790M)

    3. Significant cardiovascular disease, such as uncontrolled hypertension, myocardial infarction within the last 6 months, unstable angina pectoris, CHF ≥ NYHA 2, serious arrhythmia, significant peripheral vascular disease

    3. Pre-existing neuropathia ≥ grade 2 (NCI CTCAE V4.03)

    5. Patients with confirmed HIV infection

    6. Prior history of malignancy except for basal cell carcinoma or carcinoma in situ of the cervix, and with the exception of other malignancies after curative treatment with an interval of at least 3 years.

    7. Lactating or pregnant women, women of child-bearing potential who do not agree to the usage of highly effective contraception methods (allowed methods of contraception, meaning methods with a rate of failure of less than 1% per year are implants, injectable contraceptives, combined oral contraceptives, intrauterine pessars (only hormonal devices), sexual abstinence or vasectomy of the partner). Women of childbearing potential must have a negative pregnancy test (serum β-hCG) at Pre-Screening and Screening.

    8. Any other chemotherapy at start

    9. Treatment with other experimental drugs during the course of the study or within the last 30 days or 7 half-lifes of previously used trial medication, whatever is of longer duration, prior study start

    10. Any psychiatric illness that would affect the patient’s ability to understand the demands of the clinical trial

    11. Parallel participation in another clinical trial or participation in another clinical trial within the last 30 days or 7 half-lifes, whatever is of longer duration, prior study start

    12. Patient has already been recruited in this trial

    13. Patients who do not understand the nature, the scope and the consequences of the clinical trial

    14. Affected persons who might be dependent on the sponsor or the investigator

    14. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 AMG.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the rate of pathologic complete remissions (pCR) after induction CTx + surgery.
    The assessment will be performed according to Junker Criteria (III and IIB (pCR) vs. IIA and I (non-pCR) [see Appendix 17.6 of the protocol]. The pCR rate will be assessed both for the lymph nodes as well as the tumor. A ≥30% pCR rate (as scored III and IIB) of the lymph nodes is the aim of the study.
    E.5.1.1Timepoint(s) of evaluation of this end point
    approx. 12 month after FPI
    E.5.2Secondary end point(s)
    - Toxicity (AEs/SAEs) of induction CTx with taxane and platinum and intercalated gefitinib

    - R0 resection rate

    - Regression grading of the primary tumor according to the Junker criteria

    - radiologic response based on CT

    - progression free survival (PFS)

    - overall survival (OS)

    - relapse pattern

    - QoL during and after induction therapy with gefitinib, during and after three cycles of chemotherapy with intercalated gefitinib and after surgery
    E.5.2.1Timepoint(s) of evaluation of this end point
    after at least 12 months of follow-up unless stated otherwise obove
    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 Yes
    E.6.13.1Other scope of the trial description
    - QoL

    - Liquid biopsy project
    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.8.2.4Number 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 concerned9
    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 of follow-up
    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 months5
    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.1.3Elderly (>=65 years) Yes
    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 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 state49
    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)
    Further treatment is in discretion of the treating physician.
    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 Decision2015-09-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-03-16
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