OCEANiC: This study is investigating whether certain tests that predict the likelihood of a cancer recurrence can determine whether people with EGFR-mutant non-small cell lung cancer can safely avoid chemotherapy after their cancer has been completely removed by surgeryA Phase II, Open-label, Multi-centre Clinical Trial on effect of Osimertinib, With or Without Adjuvant Chemotherapy, Guided by Tumour Next Generation Sequencing (NGS) Co-mutation Status and circulating tumour DNA (ctDNA) Detection on disease-free survival in Patients With Stage IIA-IIIA epidermal growth factor receptor (EGFR)-Mutant Non Small Cell Lung Cancer Following Complete Surgical Resection

Summary

This study is recruiting people with non-small cell lung cancer with a mutation in epidermal growth factor receptor (known as EGFR mutation) who have had their tumour completely removed via surgery. All eligible participants will undergo co-mutation NGS profiling (which looks for gene changes in cancer tissue) and circulating tumour DNA testing (which looks for fragments of the tumour moving through the blood stream). The NGS and ctDNA results will be used to determine if a participant's cancer is at higher or lower risk of returning. Participants with a higher risk of their cancer returning will receive up to 4 cycles (over 12 weeks) of platinum doublet chemotherapy followed by up to three years of targeted therapy (with a drug called osimertinib, taken as a daily tablet). Participants with a lower risk of their cancer returning will receive only targeted therapy (osimertinib) daily via oral tablet for up to three years. It is hoped that this study will help determine if targeted therapy alone may provide similar benefits with less toxicity, improved quality of life and reduced health care costs, to chemotherapy + targeted therapy.