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A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab With Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients With Unresected Stage I/II, Lymph-node Negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515) Osimertinib Following SBRT, a Single Arm Cohort for Patients With Unresected Stage I/II, Lymph Node Negative NSCLC Harboring a Sensitizing EGFR Mutation

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Trial Profile

A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab With Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients With Unresected Stage I/II, Lymph-node Negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515) Osimertinib Following SBRT, a Single Arm Cohort for Patients With Unresected Stage I/II, Lymph Node Negative NSCLC Harboring a Sensitizing EGFR Mutation

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 15 Apr 2024

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At a glance

  • Drugs Durvalumab (Primary) ; Osimertinib
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms PACIFIC-4; PACIFIC-4/RTOG-3515
  • Sponsors AstraZeneca; AstraZeneca AB

    • Most Recent Events

    • 06 Jun 2023 Trial design presented at the 59th Annual Meeting of the American Society of Clinical Oncology.
    • 06 Jun 2023 The protocol was amended to exclude patients with an identified EGFRm from the main cohort and add a separate cohort of approximately 60 patients with EGFRm (L858R or Ex19del) who will receive osimertinib 80 mg PO QD, following SoC SBRT, for up to 36 months.
    • 25 May 2023 According to an AstraZeneca media release, trials-in-progress data will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2023.
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