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

Completed · Phase 3

Conditions studied: Anticancer Treatment

In brief

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

Key facts

Study ID

NCT02151981

Run by

AstraZeneca

People needed

421

Starts

2014-08-04

Expected to finish

2023-12-15

Last updated by the study team

2025-01-07

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• • 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

Where it is running

• Research Site — Orange, California, United States
• Research Site — Santa Rosa, California, United States
• Research Site — Norwalk, Connecticut, United States
• Research Site — Gainesville, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Pembroke Pines, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Park Ridge, Illinois, United States
• Research Site — Indianapolis, Indiana, United States
• Research Site — Marrero, Louisiana, United States
• Research Site — Chevy Chase, Maryland, United States
• Research Site — Lebanon, New Hampshire, United States
• Research Site — Brick, New Jersey, United States
• Research Site — New York, New York, United States
• Research Site — Hershey, Pennsylvania, United States
• Research Site — Charleston, South Carolina, United States
• Research Site — Houston, Texas, United States
• Research Site — Lacey, Washington, United States
• Research Site — Tacoma, Washington, United States
• Research Site — Milwaukee, Wisconsin, United States
• Research Site — Darlinghurst, Australia
• Research Site — Heidelberg, Australia
• Research Site — Kogarah, Australia
• Research Site — Nedlands, Australia
• Research Site — Anaheim, California, United States

Full record on ClinicalTrials.gov

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