OCEANiC: A Phase II, Open-label, Multi-centre Clinical Trial of Osimertinib With or Without Adjuvant Chemotherapy Guided by Tumour NGS Co-mutation Status and ctDNA Detection in Patients With Stage IIA-IIIA EGFR-Mutant Non Small Cell Lung Cancer Following Complete Surgical Resection
OCEANiC: A Phase II, Open-label, Multi-centre Clinical Trial on effect of Osimertinib, With or Without Adjuvant Chemotherapy, Guided by High-risk 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
The University of Sydney
100 participants
Sep 22, 2023
Interventional
Conditions
Summary
The purpose of this study is to investigate whether we can use co-mutation NGS profiling (looks for gene changes in your cancer tissue) and circulating tumour (ct) DNA (looks for fragments of the tumour moving through the blood stream. These fragments are known as circulating tumour DNA (ctDNA) and carry genetic information) to determine which patients with EGFR mutant non small-cell lung cancer can safely avoid chemotherapy. Who is it for? You may be eligible for this study if you are an adult with non small-cell lung cancer, with a mutation in epidermal growth factor receptor (referred to as EGFR mutation) that has had their tumour completely resected by surgery. Study details: During screening NGS profiling and ctDNA testing will be performed. The NGS and ctDNA results will be used to determine if your cancer is at higher or lower risk of returning. Participants with a higher risk of their cancer returning will have up to 4 cycles (over 12 weeks) of chemotherapy followed by up to 3 years of daily osimertinib. Participants with a lower risk of their cancer returning will have osimertinib daily for up to 3 years. The following assessments will be conducted throughout the trial: physical exam, CT scans, MRI, blood tests, pregnancy test, ECG and questionnaires. It is hoped that this study will help determine if osimertinib alone may provide similar benefits with less toxicity, improved quality of life and reduced health care costs, to chemotherapy and osimertinib.
Eligibility
Plain Language Summary
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Interventions
During screening patients are divided into 2 noncomparative cohorts, (low vs higher risk cancer recurrence) which is based on tumour tissue co-mutation status and the detection of ctDNA in plasma collected up to four weeks post-surgery. The tumour tissue used will be a sample from the surgical resection of the primary NSCLC the participant has already undergone. The plasma will be a blood test. Cohort 1 (low risk): Includes participants with absence of ctDNA and no co-mutations. Participants will receive osimertinib 80 mg orally, once daily, for up to 3 years or until disease recurrence, unacceptable toxicity. Participants will need to return osimertinib bottles at each visit to monitor treatment compliance. Cohort 2 (high risk): Includes participants with presence of ctDNA and/or presence of tumour co-mutations. Participants will receive 4 cycles of platimun doublet chemotherapy followed by osimertinib 80 mg orally, once daily, for up to 3 years or until disease recurrence, unacceptable toxicity or consent withdrawal, whichever is sooner. Participants will need to return osimertinib bottles at each visit to monitor treatment compliance. For participants in cohort 1, osimertinib should commence within 10 weeks following surgery. For participants in cohort 2, osimertinib should commence within 26 weeks following surgery.
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ACTRN12623000552684