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    Summary
    EudraCT Number:2008-006709-18
    Sponsor's Protocol Code Number:H3E-BP-JMIK
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-03-10
    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 ConcernedIreland - HPRA
    A.2EudraCT number2008-006709-18
    A.3Full title of the trial
    An exploratory, prospective phase II study to investigate progression-free survival, response and overall survival seen with pemetrexed/cisplatin and the role of thymidylate synthase expression.
    A.4.1Sponsor's protocol code numberH3E-BP-JMIK
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEli Lilly and Company Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Alimta
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V.
    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.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Advanced non-squamous non small cell lung cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10025054
    E.1.2Term Lung cancer non-small cell stage IIIB
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10025055
    E.1.2Term Lung cancer non-small cell stage IV
    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 determine the correlation between TS expression and PFS.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are as follows:
    - To determine the objective tumour response rate and overall survival rate at 18 months.
    - To determine the level of concordance between local versus central histology review.
    - To determine the biological characteristics of the more favourable (PFS ≥ 5.2 months) and less favourable (PFS <5.2 months) outcome groups.
    - To assess biomarkers relevant to the disease state and their correlation to clinical outcome.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The current Summary of Product Characteristics (SmPC) for pemetrexed will form the basis of patient selection. Patients are eligible to be included in the study only if they meet all of the following criteria:
    1. Histological diagnosis of NSCLC which, in the opinion of the local pathologist and the treating physician, is non-squamous cell histology. Pathology must be reviewed and confirmed prior to enrollment at the investigational site where the patient is entered. Patients will be enrolled based on local diagnosis; however, an independent centralised pathology review will be performed on all enrolled patients.
    2. Adequate tumour biopsy specimen must be available for TS assessment. The local diagnostic slides, pathology report and tissue material must be available for central review.
    3. Stage IIIB (with pleural effusion and/or positive supraclavicular lymph nodes) or Stage IV prior to induction therapy, as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer, that is not amenable to curative therapy.
    4. Have ECOG performance status of 0-1.
    5. Have had no prior systemic treatment (for example chemotherapy, vaccination etc) for lung cancer, including previous adjuvant and neoadjuvant therapy.
    6. Previous palliative radiotherapy to non-target metastatic lesions is allowed to <25% of the bone marrow (Cristy & Eckerman, 1987). This should have been limited and must not have included whole pelvis radiation. Patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed 30 days before study enrollment. Lesions that have been radiated cannot be included as sites of measurable disease unless clear tumour progression has been documented in these lesions since the end of radiation therapy.
    7. At least 1 unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumours (RECIST). The lesion should be at least 10mm in longest diameter by spiral computerized tomography (CT) scan, or at least 20mm by standard techniques. Tumour assessment at baseline should preferably be done with CT scan, although positron emission tomography (PET)-CT scans are acceptable for inclusion. (CT scans should be used throughout the study for all further treatment assessments). Ultrasound may not be used for tumour measurements.
    8. Estimated life expectancy of at least 12 weeks.
    9. Patient compliance and geographic proximity that allow adequate follow up.
    10. Adequate organ function, including the following:
    a. Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) >=1.5 x 109/L, platelets >=100 x 109/L, and haemoglobin >=9 g/dL.
    b. Hepatic: bilirubin <=1.5 times the upper limit of normal (x ULN); alkaline phosphatase (AP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) <=3.0 x ULN (AP, AST, and ALT <=5 x ULN is acceptable if liver has tumour involvement).
    c. Renal: calculated creatinine clearance (CrCl) >=45 mL/min based on the original weight based Cockcroft and Gault formula.
    11. Males or females at least 18 years of age, and capable of giving informed consent.
    12. For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test within 3 days before study enrollment and must not be breast-feeding.
    For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 6 months after the treatment period.
    E.4Principal exclusion criteria
    Patients will be excluded from the study if they meet any of the following criteria:
    13. Have small cell, large cell neuroendocrine or carcinoid histology, squamous cell carcinoma or tumours with a predominantly squamous component.
    14. Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
    15. Have a serious, uncontrolled medical condition that, in the opinion of the investigator, would compromise the patient’s ability to adhere to the protocol.
    16. Have a second primary malignancy (except adequately treated non-melanomatous skin cancer, or other cancer that is considered cured by surgical resection or radiation). Patients who had another malignancy in the past, but have been disease-free for more than 5 years are eligible.
    17. Have central nervous system (CNS) metastases (unless the patient has completed successful local therapy for CNS metastases and the investigator is convinced that the patient can take part). A screening CT scan or magnetic resonance imaging (MRI) before enrollment in the absence of a clinical suspicion of brain metastases is not required.
    18. Are receiving concurrent administration of any other systemic antitumour therapy, including adjuvant chemotherapy.
    19. Have clinically detectable (by physical examination) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
    20. Have received a recent (within 30 days of enrollment) or are receiving concurrent yellow fever vaccination.
    21. Are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose <=1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
    22. Are unable or unwilling to take folic acid, vitamin B12 supplementation, or corticosteroids.
    23. Are pregnant or breastfeeding.
    E.5 End points
    E.5.1Primary end point(s)
    Objective Progression-Free Survival (PFS) Time: Objective PFS time is defined as the time from the date of induction treatment to the first date of objectively determined PD or death from any cause. For patients not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last objective progression-free disease assessment. For patients who receive subsequent systemic anticancer therapy (after discontinuation from the study drug) prior to objectively determined disease progression or death, PFS will be censored at the date of the last objective progression-free disease assessment prior to postdiscontinuation chemotherapy.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    The role of Thymidylate Synthase expression.
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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 Information not present in EudraCT
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 58
    F.4.2.2In the whole clinical trial 68
    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 Decision2009-05-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-06-10
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