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A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 In Completely Resected Non-Small Cell Lung Cancer
Other Non-Commercial Sponsor
National Health & Medical Research Council (NHMRC)
BR.31 a clinical research study that is testing MEDI4736, a new type of drug for the treatment of non-small cell lung cancer (NSCLC) that was completely removed with surgery. It is being led by the Australasian Lung Cancer Trials Group (ALTG) and coordinated by the National Health and Medical Research Council Clinical Trials Centre (NHMRC CTC). The purpose of this study is to find out whether it is better to receive the new drug, MEDI4736, or no further treatment after surgery (and possibly chemotherapy) for lung cancer.
The study involves randomly allocating participants to receive treatment with either MEDI4736 or placebo, a substance that has no active medicine in it. Two-thirds (2/3) of the participants in this study will receive MEDI4736 and the other third (1/3) will receive placebo.
Participants will be required to receive intravenous infusions of MEDI4736 or placebo at 10mg/kg every 2 weeks for 6 months followed by intravenous infusions of MEDI4736 or placebo at 20mg/kg every 4 weeks for 6 months. Participants will then be followed up for a maximum of 10 years to assess overall survival and disease free survival.