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Protocol No. UW18087

Principal Investigator Traynor, Anne

Phase III

Age Group Adult

Scope National

Sponsor Type Industry

Title A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, International Study of Osimertinib as Maintenance Therapy in Patients with Locally Advanced, Unresectable EGFR Mutation-positive Non-Small Cell Lung Cancer (Stage III) Whose Disease has not Progressed Following Definitive Platinum-based Chemoradiation Therapy (LAURA)

Objective The purpose of this study is to see if osimertinib can prolong or improve the benefit you have already received from your initial treatment with chemoradiation. To do this, a comparison will be made between patients who receive the study drug and patients who receive placebo (a dummy treatment that looks like the study drug but contains no active ingredient). Both groups of patients will also continue to receive best supportive care whilst taking either the study drug or placebo. The use of osimertinib in this study is investigational, meaning it has not been approved for this use by the Food and Drug Administration (FDA)

Treatment Patients will be randomized in a 2:1 ratio to one of two treatment arms as follows:
  • Osimertinib/placebo 80 mg orally once daily

  • Description Phase 3, Double-blind, Placebo-controlled Study of Osimertinib in Stage 3 EGFR Positive Patients with Non-Small Cell Lung Cancer

    Key Eligibility
    Part I Screening Part I screening applies only to patients that do not have a pre-existing local positive as defined by the protocol
  • Provision of signed and dated written informed consent for Part I screening form prior to any mandatory provision of tumor samples for testing of EGFR mutation status
  • Male and Female patient must be aged at least 18 years
  • Patients with histologically documented NSCLC of predominantly non-squamous pathology who present with locally advanced, unresectable (Stage III) disease
  • Patient who can provide an unstained archived formalin-fixed paraffin embedded tumor tissue sample in a quantity sufficient to allow for prospective central analysis of EGFR mutation status
    Part II Screening: patients that have a pre-existing local positive (Exon 19 Deletion or L858R) cobas® EGFR Mutation Test, or patients who completed Part I screening and have centrally confirmed EGFR mutation (Ex19 Deletion or L858R) positive NSCLC
  • Patients must not have had disease progression during or following definitive platinumbased, chemoradiation therapy
  • Patients must have received either concurrent chemoradiation or sequential chemoradiation regimens as defined by the protocol
  • The platinum-based chemotherapy regimen must contain one of the following agents: etoposide, vinblastine, vinorelbine, paclitaxel, docetaxel, or pemetrexed, according to the local standard of care regimens. Gemcitabine is permitted if used prior to radiation but not with radiation
  • Patients must have received a total dose of radiation of 60 Gy ┬▒10% (54 to 66 Gy) as part of the chemoradiation therapy in order to be randomized
  • World Health Organization (WHO) performance status of 0 or 1
  • Life expectancy greater than 12 weeks
  • Female patients of childbearing potential must agree to adequate birth control as defined by the protocol, they can not be pregnant or breastfeeding
  • Male patients must be willing to use barrier contraception, i.e., condoms
    EXCLUSION:
  • Mixed small cell and non-small cell lung cancer histology
  • History of interstitial lung disease (ILD) prior to chemoradiation
  • Symptomatic pneumonitis following chemoradiation
  • Inadequate cardiac function as described by the protocol
  • Inadequate bone marrow reserve or organ function as described by the protocol
  • Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
  • Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib
  • Prior treatment with any prior chemotherapy, radiation therapy, immunotherapy or investigational agents for NSCLC outside of that received in the definitive setting for Stage III disease (chemotherapy and radiotherapy in SCRT and CCRT regimens is allowed for treatment of Stage III disease). Prior surgical resection (i.e. stage I or II) is permitted
  • Prior treatment with EGFR-TKI therapy
  • Prior allogeneic bone marrow transplant

  • Applicable Disease Sites Lung

    Status Open

    Participating Institutions UW Hospital and Clinics