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
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
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
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Anticancer Treatment
Age (in years)
18 - 130
Phase
Phase 3
Participants needed
419
Est. Completion Date
Dec 29, 2023
Treatment type
Interventional
Sponsor
AstraZeneca
ClinicalTrials.gov identifier
NCT02151981
Study number
D5160C00003
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