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

NCT02151981

CompletedPhase 3

Sponsor: AstraZeneca

Conditions: Anticancer Treatment

Interventions: Chemotherapy, Cross-over to Osimertinib

Countries: United States, Australia, Canada, China, France, Germany, Hong Kong, Hungary

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

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (150)
  • Anaheim, California, United States
  • Orange, California, United States
  • Santa Rosa, California, United States
  • Norwalk, Connecticut, United States
  • Gainesville, Florida, United States
  • Orlando, Florida, United States
  • Pembroke Pines, Florida, United States
  • Atlanta, Georgia, United States
  • Park Ridge, Illinois, United States
  • Indianapolis, Indiana, United States
  • Marrero, Louisiana, United States
  • Chevy Chase, Maryland, United States
  • Lebanon, New Hampshire, United States
  • Brick, New Jersey, United States
  • New York, New York, United States
  • Hershey, Pennsylvania, United States
  • Charleston, South Carolina, United States
  • Houston, Texas, United States
  • Lacey, Washington, United States
  • Tacoma, Washington, United States
  • Milwaukee, Wisconsin, United States
  • Darlinghurst, Australia
  • Heidelberg, Australia
  • Kogarah, Australia
  • Nedlands, Australia
  • Woolloongabba, Australia
  • Edmonton, Alberta, Canada
  • Vancouver, British Columbia, Canada
  • Halifax, Nova Scotia, Canada
  • Ottawa, Ontario, Canada
  • + 120 more on CT.gov