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    Summary
    EudraCT Number:2012-003383-51
    Sponsor's Protocol Code Number:2012/VCC/0037
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-03
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-003383-51
    A.3Full title of the trial
    A randomised phase II trial of Olaparib maintenance versus placebo monotherapy in patients with non-small cell lung cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Parp Inhibitor in advanced non-small cell lung cancer
    A.3.2Name or abbreviated title of the trial where available
    PIN
    A.4.1Sponsor's protocol code number2012/VCC/0037
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01788332
    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 SponsorVelindre NHS Trust
    B.1.3.4CountryUnited Kingdom
    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.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWales Cancer Trials Unit
    B.5.2Functional name of contact pointSarah Bridges
    B.5.3 Address:
    B.5.3.1Street Address6th Floor, Neuadd Meirionnydd, Heath Park
    B.5.3.2Town/ cityCardiff
    B.5.3.3Post codeCF14 4YS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02920687581
    B.5.5Fax number02920687501
    B.5.6E-mailBridgesSE@cardiff.ac.uk
    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.2.5The 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 nameOlaparib
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    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
    E.1.1.1Medical condition in easily understood language
    NSCLC is the most common form of lung cancer, accounting for 85 to 90% of all lung cancer cases. It tends to grow and spread more slowly than small cell.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10025054
    E.1.2Term Lung cancer non-small cell stage IIIB
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10025055
    E.1.2Term Lung cancer non-small cell stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    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 main objective of this trial is to establish whether treatment with Olaparib in NSCLC patients who have already responded to induction chemotherapy delays disease progression compared to placebo.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this trial are to determine if Olaparib is a safe, feasible and tolerable maintenance therapy in NSCLC patients following induction chemotherapy. Other anti-tumour activities as measured by response, tumour volume reduction and overall survival will be also be determined. Finally, the study will also be used to collect blood and tissue samples from this population to facilitate future translational research.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The translational sub-study is part of the main PIN protocol.
    Objectives: Blood will be collected from all registered participants before induction chemotherapy starts. Follow-up bloods will then be collected upon disease progression (if progressing after the initial induction chemotherapy stage), at randomisation, and upon disease progression for those patients who are randomised. The formalin fixed NSCLC tissue that was taken at diagnosis (standard care) will also be collected on all patients registered to the study at time of induction chemotherapy. The tissues will be used to assess biomarkers associated with synthetic lethality. It is hypothesised that the loss of BRCA1 expression will be enriched in NSCLCs that have responded to induction chemotherapy. Patients who have gone through to the randomisation stage will also have the option to have a second biopsy upon disease progression.
    E.3Principal inclusion criteria
    At registration:
    1)Histological diagnosis of NSCLC. Histology can be either squamous or non-squamous. The same block or 10 unstained slides must be available for translational research.
    2)Stage IIIB or stage IV lung cancer, that is not amenable to curative therapy
    3)ECOG performance status 0-1
    4)Have had no prior systemic treatment for lung cancer including previous adjuvant and neoadjuvant therapy. Patients who have already started their induction chemotherapy are not eligible.
    5)Eligible to receive standard platinum doublet- based chemotherapy
    6)Men or women, aged 18 or over and capable of giving informed consent
    7)Willing to consent to provide tissue and blood for translational research
    8)Informed consent prior to any study procedures.

    At randomisation:
    1)Partial or complete response to platinum containing doublet chemotherapy after a minimum of 3 cycles, as assessed by the local radiologist.
    2)Adequate organ function, including the following:
    a. Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L , Haemoglobin of ≥ 10g/dL.
    b. Hepatic: total bilirubin ≤ 1.5 times the upper limit of normal (x ULN); alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤ 2.5 x ULN. ALP, AST, and ALT ≤ 5 x times ULN is acceptable if the liver has tumour involvement
    c. Renal: calculated creatinine clearance (CrCl) ≥ 50mL/min based on the original weight based Crockcroft and Gault formula, Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN)
    d. If blood count suggestive of MDS/AML, no features suggestive of MDS/AML on peripheral blood smear
    3)Patients with reproductive potential must be prepared to use adequate contraception throughout the study and for three months after the last dose of Olaparib.
    4)Informed consent prior to any study specific procedures.
    E.4Principal exclusion criteria
    At registration:
    1)Evidence of small cell, large cell neuroendocrine or carcinoid histology
    2)Have a serious or uncontrolled medical condition that in the opinion of the investigator would compromise the patients ability to adhere to the protocol
    3)Have a secondary 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.
    4)Have had a blood transfusion within 4 weeks prior to entry and have a WBC >3 x 10^9/L.
    5)Have central nervous system (CNS) metastases (unless the patient has completed successful local therapy for CNS metastases eg. Involving complete surgical removal or radical radiotherapy to a solitary CNS metastasis ).
    6)Are receiving concurrent administration of any other systemic antitumour therapy
    7)Have received a recent (within 30 days of enrolment) or are receiving a concurrent yellow fever vaccination.
    8)Previous treatment with PARP inhibitors
    9)Difficulty swallowing
    10)Uncontrolled GI disorders such as active diverticulitis or colitis, or any major GI resection which could have an impact on patients' ability to absorb Olaparib.
    11)Patients with myelodysplastic syndrome/Acute myeloid leukaemia
    12)Congenital long QT syndrome

    At randomisation:
    1)Patients with radiological disease progression or stable disease
    2)Have received treatment with an agent that has not received regulatory approval, within 30 days of study entry
    3)Have had a blood transfusion within 4 weeks prior to entry and have a WBC >3 x 10^9/L.
    4)Resting ECG with QTc>/-480 msec.
    5)Are pregnant or breastfeeding.
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival (PFS - time to event) based on Response Evaluation Criteria in Solid Tumours (RECIST v1.1). Time from randomisation to any progression (based on RECIST) and/or death. Those progression-free and alive will be censored at time last seen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Upon disease progression or 1 year post randomisation, whichever comes first.
    E.5.2Secondary end point(s)
    - Safety, tolerability (side effects) and feasibility of use (number of participants requiring dose delays or reductions and/or treatment withdrawal).
    - Objective response rate as assessed by RECIST v1.1.
    - Overall survival (OS), time from randomisation to death with those still alive censored at date last seen.
    - Change in tumour volume-reduction - from randomisation to 6 weeks.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At one year post randomisation, apart from the change in tumour volume-reduction which has a timepoint of 6 weeks.
    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 Yes
    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 Yes
    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) Yes
    E.8.2.2Placebo Yes
    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 concerned20
    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
    The end date is the date of last data capture.
    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 months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state114
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 114
    F.4.2.2In the whole clinical trial 114
    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)
    If patients are benefitting from olaparib/placebo then there will be provision to continue treatment after the 60 weeks.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Wales Cancer Trials Unit
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-02-22
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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