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    Summary
    EudraCT Number:2016-003924-22
    Sponsor's Protocol Code Number:ML39349
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-03-30
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-003924-22
    A.3Full title of the trial
    AN OPEN-LABEL, MULTICENTER, SINGLE-ARM, PHASE II STUDY TO ASSESS THE EFFICACY AND SAFETY OF ALECTINIB IN PATIENTS WITH ALK-REARRANGED NON−SMALL CELL LUNG CANCER AFTER DISEASE PROGRESSION ON PRIOR ALK INHIBITOR THERAPY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial of alectinib for treatment of ALK-rearranged non-small cell lung cancer.
    A.4.1Sponsor's protocol code numberML39349
    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 SponsorROCHE 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 supportROCHE SAS
    B.4.2CountryFrance
    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 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 nameAlectinib
    D.3.2Product code RO5424802
    D.3.4Pharmaceutical form Capsule, hard
    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 INNALECTINIB
    D.3.9.2Current sponsor codeRo542-4802/F03
    D.3.9.3Other descriptive nameALK INHIBITOR
    D.3.9.4EV Substance CodeSUB178557
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    ALK-rearranged non-small cell lung cancer (NSCLC) after disease progression on prior ALK inhibitor therapy
    E.1.1.1Medical condition in easily understood language
    ALK+ NSCLC is a type of cancer that forms in tissues of the lung, and has an alteration in the ALK gene
    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 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 20.0
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To estimate Objective Response Rate (ORR) in all patients with measurable disease at baseline
    E.2.2Secondary objectives of the trial
    Central Nervous System Objective Response Rate (C-ORR) in all patients with measurable CNS metastases at baseline.
    Progression-Free Survival (PFS) in all patients.
    Time to Progression in all patients.
    Disease Control Rate (DCR) in all patients with measurable disease.
    Duration Of Response (DOR) in all patients with measurable disease.
    CNS Duration Of Response (C-DOR) in all patients with measurable CNS metastases at baseline.
    Overall Survival (OS) rate at two-years in all patients.
    Time to CNS progression in all patients.
    Quality of life (QLQ-C30, LC13, BN20 questionnaires for patients with CNS metastases and EQ-5D-5L).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with histologically or cytologically confirmed locally advanced or metastatic NSCLC (Stage IIIB or IV accordingly to American Joint Committee on Cancer [AJCC] classification)
    - Male or female ≥ 18 years old
    - Life expectancy of at least 12 weeks, in the opinion of the Investigator
    - Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2
    - Patients having:
    a) contributive biopsy performed on fresh tissue (FFPE blocks required) taken after progression on previous therapy showing:
    - presence of anaplastic lymphoma kinase (ALK) rearrangement, assessed by IHC and confirmed by FISH,
    - absence of resistance mechanism to alectinib assessed by the Biomarkers Board:
    1. ALK I1151Tins I1171N/S, V1180L and G1202R mutations (known to induce a resistance to alectinib),
    2. epidermal growth factor receptor (EGFR) exon 19 deletions, L858R mutation or Kirsten rat sarcoma viral oncogene homolog (KRAS) codon 12, 13 or 61 mutations,
    3. High level of MET amplification,
    4. tumor histologic transformation into small cell lung cancer.
    b) disease progression, limited to CNS without possibility of tissue biopsy,
    c) non-contributive molecular analyses (no enough tumor cells or DNA amount or failure of analyses for technical reasons): inclusion is at investigator discretion (his decision taken upon Biomarker Board recommendation)
    - History of crizotinib exposure
    - Adequate hematologic function
    - Adequate renal function
    - For all females of childbearing potential, a negative pregnancy test must be obtained within three days before starting study drug
    - For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of < 1% per year, during the treatment period and for at least 90 days after the last dose of study drug
    - For men: agreement to remain abstinent or use a barrier method of contraception (e.g., condom) during the treatment period and for at least 90 days after the last dose of study drug and agreement to refrain from donating sperm during this same period
    - Patient has national health insurance coverage
    E.4Principal exclusion criteria
    - Prior therapy with other ALK inhibitors than crizotinib (including alectinib)
    - Patients with symptomatic CNS metastases who are neurologically unstable or require increasing doses of steroids within one week prior to Day 0 to manage CNS symptoms (Patients with brain or leptomeningeal metastases are allowed, symptomatic disease is allowed as long as symptoms are controlled and stable and prior treatment with whole brain radiation or gamma knife must have been completed at least 14 days prior to Day 0 and patients must be clinically stable)
    - Patients with progression limited to CNS and eligible to a focal treatment (surgery or stereotaxic radiotherapy)
    - Liver disease characterized by: Alanine transaminase (ALT) or aspartate aminotransferase (AST) > 3 × upper limit of normal (ULN) (≥ 5×ULN for patients with concurrent liver metastasis) confirmed on two consecutive measurements
    OR Impaired excretory function (e.g., hyperbilirubinemia) or synthetic function or other conditions of decompensated liver disease such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices.
    OR Acute viral or active autoimmune, alcoholic, or other types of hepatitis
    - Patients with baseline QTc > 470 ms or patients with symptomatic bradycardia.
    - Pregnant or lactating women
    - Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry
    - Serious, uncontrolled infections or current known infection with human immunodeficiency virus (HIV)
    E.5 End points
    E.5.1Primary end point(s)
    ORR, defined as the percentage of patients who achieve complete response (CR) or partial response (PR) as determined by Investigators using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v.1.1)
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    E.5.2Secondary end point(s)
    C-ORR in all patients with measurable CNS metastases at baseline
    PFS in all patients
    TTP in all patients
    DCR in all patients
    DOR in all patients
    C-DOR in all patients
    Two-year OS
    Time to CNS progression
    E.5.2.1Timepoint(s) of evaluation of this end point
    C-ORR: 12 months
    PFS: 24 months
    TTP: 24 months
    DCR: 12 months
    DOR: 24 months
    C-DOR: 24 months
    OS: 24 months
    Time to CNS progression: 24 months
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    To assess exploratory biomarkers
    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 Yes
    E.8.1.7.1Other trial design description
    Single arm
    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 concerned21
    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
    Las patient Last visit
    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 months3
    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: 63
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state73
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 73
    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)
    The Sponsor will offer post-trial access to the study drug (alectinib) free of charge to eligible patients if all of the following conditions are met:
    • The patient requires continued study drug treatment for his or her well-being.
    • There are no appropriate alternative treatments available to the patient.
    • The patient and his or her doctor comply with and satisfy any legal or regulatory requirements that apply to them.
    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 Decision2017-03-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-09-26
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