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
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
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.