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A Randomized, Multicenter, Phase Ib/III Study to Investigate the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Subcutaneous Compared With Atezolizumab Intravenous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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Trial Profile

A Randomized, Multicenter, Phase Ib/III Study to Investigate the Pharmacokinetics, Efficacy, and Safety of Atezolizumab Subcutaneous Compared With Atezolizumab Intravenous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Mar 2024

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At a glance

  • Drugs Atezolizumab (Primary) ; Atezolizumab (Primary) ; Hyaluronidase (Primary)
  • Indications Non-small cell lung cancer
  • Focus Pharmacokinetics; Registrational
  • Acronyms IMscin001
  • Sponsors Roche

    • Most Recent Events

    • 16 Jan 2024 According to a Roche media release, company announced that the European Commission has granted marketing authorisation for Tecentriq (atezolizumab) SC injection. The approval is based on pivotal data from the Phase IB/III IMscin001 study.
    • 14 Nov 2023 According to a Roche media release, data from the Phase IB/III IMscin001 study, company announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of subcutaneous (SC, or under the skin) Tecentriq (atezolizumab). A final decision on its approval is expected from the European Commission in the near future.
    • 24 Oct 2023 Results of part 2 , presented at the 48th European Society for Medical Oncology Congress.
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