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    Summary
    EudraCT Number:2018-002382-19
    Sponsor's Protocol Code Number:PDC-LUNG-101
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-01-30
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-002382-19
    A.3Full title of the trial
    An open-label, dose-escalation, phase I/II study to assess the safety, the tolerability, the immunogenicity and the preliminary clinical activity of the therapeutic cancer vaccine, PDC*lung01, associated or not with anti-PD-1 treatment in patients with non-small-cell lung cancer (NSCLC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety, immunogenicity and preliminary clinical activity study of PDC*lung01 cancer vaccine in NSCLC
    A.4.1Sponsor's protocol code numberPDC-LUNG-101
    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 SponsorPDC*line Pharma SAS
    B.1.3.4CountryFrance
    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 supportPDC*line Pharma SAS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPDC*line Pharma SA
    B.5.2Functional name of contact pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressAvenue de l'hopital 11
    B.5.3.2Town/ cityLiège
    B.5.3.3Post code4000
    B.5.3.4CountryBelgium
    B.5.4Telephone number+32474910183
    B.5.6E-mailc.maurin@pdc-line-pharma.com
    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 namePDC*lung01
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUnknown
    D.3.9.1CAS number Unknown
    D.3.9.2Current sponsor codePDC*lung01
    D.3.9.4EV Substance CodeSUB195402
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms/ml million organisms/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4.67 to 46.7
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberPDC*vac; Somatic cell therapy medicinal product; Ref. EMA/556392/2015
    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) Yes
    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
    Non-small-cell lung cancer
    E.1.1.1Medical condition in easily understood language
    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 20.0
    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
    Assess safety and tolerability of PDC*lung01 vaccinations administered at two dose levels as single agent or during maintenance treatment by pemetrexed (for adenocarcinomas in Cohorts A1 and A2) or during treatment with anti-PD-1 therapy (Cohorts B1 and B2).
    E.2.2Secondary objectives of the trial
    - Evaluate the safety of the combined use of PDC*lung01 with anti-PD-1 therapy
    - Document additional indicators of safety / tolerability
    - Evaluate the humoral allogeneic immune response against PDC*line cells
    - Evaluate the specific T-cell response against the antigens borne by PDC*lung01 vaccine
    - Document preliminary clinical activity in patients with stage IV NSCLC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pre-screening:
    Documented HLA-A*02:01 positivity after the patient has provided written informed consent to participate in the study.

    Screening:
    1.Patients with histologically proven, or cytologically proven (allowed only for patients recruited in cohorts A1/A2), non-small-cell lung cancer (NSCLC). The stage of the disease is evaluated according to the classification of the American Joint Committee on Cancer, 8th edition (see Section 25.1)
    a.For the dose-escalation phase (Cohorts A1 and A2): a wash-out period of at least 4 weeks after administration of the last cycle of platinum-based chemotherapy is required.
    (i)Stage IIa/IIb/IIIa NSCLC following surgery and, if applicable, adjuvant platinum-based chemotherapy, or
    (ii)Stage IV histologically or cytologically confirmed case of epidermoid (squamous) NSCLC following 4 courses of platinum-based therapy, or
    (iii)Stage IV histologically or cytologically confirmed case of adenocarcinoma (non-squamous) lung cancer NSCLC following 4 to 6 courses cycles of pemetrexed and platinum combination,
    (iv)Populations (ii) and (iii) who have stopped prematurely chemotherapy, after at least 2 cycles of platinum-based therapy, for any reason, AND do present with a documented control disease.
    b.For the anti-PD-1 immunotherapy (Cohorts B1 and B2):
    -The patient has first-line metastatic stage IV NSCLC disease and is starting anti-PD-1. The intention and decision to prescribe the anti-PD-1 monotherapy as SoC (TPS≥50%) must have been made by the investigator before and regardless of the patient’s participation in the study.
    2.ECOG performance status 0 or 1.
    3.Adequate renal and hepatic function as defined below:
    •Serum creatinine clearance > 50 mL/min (Cockcroft–Gault formula)
    •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
    •Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times ULN (up to 5 times ULN are allowed in case of presence of liver metastases).
    4.Adequate haematological function as defined below:
    •Platelet count ≥ 70x10^9 /L;
    •White blood cell count ≥ 2.5 x 10^9 /L with
    •lymphocytes >1x10^9 /L, among which ≥ 10 % of CD8+ T cells and
    •absolute neutrophil count: >1.5x10^9/L,
    •Haemoglobin ≥ 90 g/L
    5.Patient willing and able to provide a baseline blood sample for leucocyte enumeration, cellular allogeneic response and immune-monitoring of 100 ml in total (in one or two samplings).
    6.For patients with brain metastases:
    •Central nervous system metastases are not symptomatic and have been treated,
    •In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤10mg daily prednisone (or equivalent) during at least 2 weeks before baseline.
    7.For female patients without child-bearing potential: a documentation of tubal ligation or hysterectomy, ovariectomy or a post-menopausal status is available.
    For female patients of child-bearing potential: a negative serum pregnancy test at screening is provided. The patient agrees to practice a “double barrier” contraception for at least 30 days before the first of administration of PDC*lung01, throughout the study treatment period and for at least 28 days after the last administration of PDC*lung01.
    8. Males with reproductive potential should use barrier method of contraception (condom) from screening up to at least 28 days after the last dose of PDC*lung01
    9. In the Investigator’s opinion, the patient is able and willing to comply with the requirements of the study.
    10. Patient willing and able to sign the study informed consent form before any study-specific procedures are conducted.
    11. Patient (male or female) is aged 18 years or above.
    E.4Principal exclusion criteria
    1.Mixed small-cell and non-small-cell histological features.
    2.Patient has received immunotherapy or any investigational drugs within 4 weeks before the first PDC*lung01 dose.
    3.Patient is receiving systemic corticosteroids at a dose level exceeding 10 mg/day (prednisone or equivalent) OR he/she has been receiving systemic corticosteroids for a period longer than 10 days before baseline (administration by nasal spray, topical solution or oral inhaler is non-systemic and is therefore allowed).
    4.Patient has a medical history of cancer other than NSCLC, except the following: (i) non-melanoma skin cancer with complete resection, (ii) in situ carcinoma of the cervix, (iii) other cancer treated with no evidence of disease for at least five years.
    5.Patient presents at screening anti-HLA antibodies against HLA molecules expressed by the PDC*line.
    6.Known hepatitis B and/or C infection (testing not required).
    7.Known positive for human immunodeficiency virus (HIV; testing not required).
    8.Uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease with unstable angina or myocardial infarction within 6 months of baseline) or uncontrolled ventricular arrhythmias at the time of enrolment in the study (atrial fibrillation or flutter is acceptable).
    9.Any history of splenectomy or splenic irradiation.
    10.For female patients: pregnancy or lactation.
    12.Any condition, including autoimmune or immunodeficiency active disease that, in the opinion of the Investigator, would jeopardise patient’s safety, or might compromise the effect of the study drug or the assessment of the study result.
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of dose-limiting toxicities (DLT) related to the administration of PDC*lung01
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline (Day 1/Week 1), D7, D14, D21, D28, D35 and D63
    E.5.2Secondary end point(s)
    - Occurrence of serious adverse events (SAEs) and adverse events (AEs), deemed as related to the association of PDC*lung01 and the anti-PD-1 therapy
    - Occurrence of serious adverse events (SAEs) and adverse events (AEs)
    - Measurement of anti-HLA class I and II antibodies in the serum
    - Ex vivo detection and characterization of CD8+ T cells against tumor antigens borne by PDC*lung01, using flow cytometry.
    - Objective Response Rate (according to RECIST version 1.1)
    - Progression-Free Survival
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Safety: Baseline (Day 1/Week 1), D7, D14, D21, D28, D35 and D63
    - Anti-HLA antibodies: Screening, D35 and D63
    - Ex vivo detection of antigen specific CD8: Screening, D35 and D63
    - ORR: D63
    - PFS: 9 months from the first day of platinum-based or anti-PD-1 antibody administration
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Dose-escalation design
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    LVLP
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    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: 66
    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 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 state44
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 66
    F.4.2.2In the whole clinical trial 66
    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)
    None
    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 Decision2019-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-13
    P. End of Trial
    P.End of Trial StatusOngoing
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