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A Phase III, Open Label, Randomized Study of AZD9291 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 (AURA3)
A study for patients with locally advanced or metastatic non-small cell lung cancer using study drug AZD9291
| Sponsor: | AstraZeneca |
| Enrolling: | Male and Female Patients |
| IRB Number: | AAAO0858 |
| U.S. Govt. ID: | NCT02151981 |
| Contact: | Ryan Shelton: 212-304-5485 / rs3323@cumc.columbia.edu |
Additional Study Information:
The purpose of this study is to see if study drug AZD9291 is effective in treating non-small cell lung cancer (NSCLC) and if so, how it compares with chemotherapy. Only patients with NSCLC that has been confirmed as having the EGFR mutation are eligible to participate. Before patients can participate in the main study a tumor sample will be taken to check to see if it also has the T790M mutation. Only patients with the T790M mutation will be able to receive the study drug (AZD9291 or platinum-based doublet chemotherapy). Participants in this study will receive AZD9291 or platinum-based doublet chemotherapy (pemetrexed + carboplatin or pemetrexed + cisplatin). This study will also measure levels of drug in the blood and to see how well it is tolerated.
This study is closed