CompletedPhase 3NCT02151981

AZD9291 (Osimertinib) Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

A Phase III, Open Label, Randomized Study of Osimertinib versus Platinum-Based Doublet Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene

Checked against the public recordLast updated Jan 7, 2025 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 3
U.S. locations150
SponsorAstraZeneca
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
AstraZeneca
Interventions being studied
Drug: Chemotherapy; Drug: Cross-over to Osimertinib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Subjects with histologically or cytologically documented NSCLC. * Locally advanced or metastatic NSCLC * Radiological documentation of disease progression following 1st line EGFR TKI Treatment without any further treatment * Eligible to receive treatment with the selected doublet-chemotherapy * Central confirmation of T790M+ mutation status * World Health Organization (WHO) performance status 0-1 * At least one lesion, not previously irradiated. Exclusion Criteria: * • Prior neo-adjuvant or adjuvant chemotherapy treatment within 6 months prior of starting 1st EGFR TKI treatment * Treatment with more than one prior line of treatment for advanced NSCLC * Treatment with an approved EGFR-TKI (e.g.,erlotinib, gefitinib, afatinib) within 8 days or approximately 5x half-life of the first dose of study treatment * Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment * Previous treatment with Osimertinib, or a 3rd generation EGFR TKI For subjects who cross-over to Osimertinib: * Once subjects on the platinum-based doublet chemotherapy arm are determined to have objective radiological progression according to RECIST 1.1 by the investigator and confirmed by independent central imaging review. * At least 14 days since last dose of platinum-based doublet chemotherapy

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Research SiteAnaheim, California
  • Research SiteOrange, California
  • Research SiteSanta Rosa, California
  • Research SiteNorwalk, Connecticut
  • Research SiteGainesville, Florida
  • Research SiteOrlando, Florida
  • Research SitePembroke Pines, Florida
  • Research SiteAtlanta, Georgia
  • Research SitePark Ridge, Illinois
  • Research SiteIndianapolis, Indiana
  • Research SiteMarrero, Louisiana
  • Research SiteChevy Chase, Maryland

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 7, 2025. Always confirm current availability with the study team.

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