For Healthcare Professionals

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


About the study

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

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

  1. Subjects with histologically or cytologically documented NSCLC.
  2. Locally advanced or metastatic NSCLC
  3. Radiological documentation of disease progression following 1st line EGFR TKI Treatment without any further treatment
  4. Eligible to receive treatment with the selected doublet-chemotherapy
  5. Central confirmation of T790M+ mutation status
  6. World Health Organization (WHO) performance status 0-1
  7. At least one lesion, not previously irradiated.


Exclusion Criteria:

  1. • Prior neo-adjuvant or adjuvant chemotherapy treatment within 6 months prior of starting 1st EGFR TKI treatment
  2. Treatment with more than one prior line of treatment for advanced NSCLC
  3. 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
  4. 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
  5. Previous treatment with Osimertinib, or a 3rd generation EGFR TKI

For subjects who cross-over to Osimertinib:

  1. 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.
  2. At least 14 days since last dose of platinum-based doublet chemotherapy

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Anticancer Treatment

Age (in years)

18 - 130


Phase 3

Participants needed


Est. Completion Date

Dec 29, 2023

Treatment type



AstraZeneca identifier


Study number


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