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Clinical trials for 2017-004781-94

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43613   clinical trials with a EudraCT protocol, of which   7207   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    1 result(s) found for: 2017-004781-94. Displaying page 1 of 1.
    EudraCT Number: 2017-004781-94 Sponsor Protocol Number: DS8201-A-U204 Start Date*: 2018-10-11
    Sponsor Name:DAIICHI SANKYO, INC.
    Full Title: A Phase 2, Multicenter, Open-Label, 2-Cohort Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2 Antibody Drug Conjugate (ADC), for HER2-Over-Expressing or -Mutated, Unresectable and/or Metast...
    Medical condition: HER2-over-expressing or -mutated, unresectable and/or metastatic non-squamous non-small cell lung cancer (NSCLC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10001246 Adenosquamous cell lung cancer NOS LLT
    21.1 100000004864 10029514 Non-small cell lung cancer NOS LLT
    21.1 100000004864 10001255 Adenosquamous cell lung cancer stage unspecified LLT
    21.1 100000004864 10001253 Adenosquamous cell lung cancer stage IIIB LLT
    21.1 100000004864 10001252 Adenosquamous cell lung cancer stage IIIA LLT
    21.1 100000004864 10066490 Progression of non-small cell lung cancer LLT
    20.0 100000004864 10079440 Non-squamous non-small cell lung cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing) ES (Ongoing)
    Trial results: View results
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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