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Clinical trials for 2015-000662-65

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
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    The EU Clinical Trials Register currently displays   44363   clinical trials with a EudraCT protocol, of which   7387   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).

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    1 result(s) found for: 2015-000662-65. Displaying page 1 of 1.
    EudraCT Number: 2015-000662-65 Sponsor Protocol Number: D5164C00001 Start Date*: 2015-08-12
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase III, double-blind, randomized, placebo-controlled multi-centre, study to assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal Growth Factor Receptor Mutation...
    Medical condition: Stage IB-IIIA non-small cell lung carcinoma, with a centrally confirmed, common sensitising EGFR mutations (Ex19del and L858R either alone or in combination with other EGFR mutations), following co...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029520 Non-small cell lung cancer stage IIIA PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029517 Non-small cell lung cancer stage I PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029518 Non-small cell lung cancer stage II PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) IT (Completed) DE (Trial now transitioned) HU (Completed) NL (Ongoing) FR (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned) SE (Trial now transitioned)
    Trial results: (No results available)
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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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