Lung cancer remains the leading cause of cancer-related deaths worldwide, with non-small cell lung cancer (NSCLC) accounting for around 80% of all cases. While surgery offers the best chance of cure for early-stage disease, the risk of recurrence remains high. Even after complete tumour removal and adjuvant (after surgery) chemotherapy, many patients relapse within five years — highlighting the urgent need for more effective and better targeted post-surgical treatments.
From One-Size-Fits-All to Precision Adjuvant Therapy
For many years, adjuvant treatment after surgery was based largely on stage and fitness rather than tumour biology. Platinum-based chemotherapy improved overall survival in landmark trials such as ALPI, IALT and ANITA, but the benefits were modest, and toxicity significant.
We now understand that NSCLC is a highly heterogeneous disease. EGFR-mutant NSCLC — which occurs in around 10–20% of Caucasian patients and up to 60% of Asian patients — responds very differently to chemotherapy and is better treated with targeted therapies known as tyrosine kinase inhibitors (TKIs). The ADAURA clinical trial established a new global standard by showing that the third-generation EGFR TKI, osimertinib, which had been successfully used in metastatic disease, dramatically reduced recurrence rates when used after surgery, with or without prior chemotherapy.
TOGA’s OCEANiC clinical trial
Despite ADAURA’s success, several unanswered questions remain. The ADAURA data suggested that patients treated with adjuvant osimertinib for 3 years had similar disease-free survival whether or not they had received adjuvant chemotherapy beforehand. Most patients did receive chemotherapy, but the study raises an important new question: is chemotherapy still necessary for all patients, or could some safely be spared its side effects?
TOGA’s OCEANiC clinical trial, refined and optimised through TOGA’s Research Development process, aims to determine if, patients with resected stage II-IIIA EGFR mutant NSCLC who receive adjuvant osimertinib monotherapy, and are at lower risk of lung cancer recurrence, can omit adjuvant chemotherapy if favourable tumour markers are present. The favourable tumour profile is based on ctDNA clearance in plasma (liquid biopsy) and the absence of co-mutations in tumour tissue.
Quality of life and additional studies to determine prognostic and predictive biomarkers for patient outcomes are important additional endpoints for this clinical trial. Importantly, all the results will improve our understanding of the role of TKIs in treatment of early-stage ‘oncogene-addicted’ NSCLC, where a particular mutation drives tumour growth. Use of TKIs that selectively target these mutations identified by genetic testing of the tumour, is the basis of precision medicine in lung cancer.
How do I refer a patient?
Potential patients need ctDNA (plasma) collected within 31 days of surgical resection. Additional information and participating sites can be found here.
If you have a potential participant, please contact your nearest active trial site.
Recruiting hospitals:
- Peter MacCallum Cancer Centre – Melbourne, VIC
- Mildura Base Public Hospital- Mildura, VIC (teletrial site)
- St Vincent’s Hospital (Melbourne) Ltd – Fitzroy, VIC
- Austin Health – Austin Hospital – Heidelberg, VIC
- Monash Medical Centre – Clayton campus – Clayton, VIC
- The Chris O’Brien Lifehouse – Camperdown, NSW
- GenesisCare – St Leonards – St Leonards, NSW
- Liverpool Hospital – Liverpool, NSW
- Westmead Hospital – Westmead, NSW
- St George Hospital, NSW
- The Prince Charles Hospital – Chermside, QLD
- Sunshine Coast University Hospital, QLD
- Fiona Stanley Hospital – Murdoch, WA
- Flinders Medical Centre Bedford Park- SA
- Auckland City Hospital- Auckland, NZ
If you have a potential patient, please contact the Principal Investigator at your local hospital or the hospital closest to you as soon as possible so the medical oncology team can start the screening process to determine patient eligibility for OCEANiC.
If you are a patient interested in this clinical trial, please discuss it with your treating physician.
If you have any questions about the OCEANiC study or need a contact to refer a patient, please do not hesitate to contact the OCEANiC team at oceanic.study@sydney.edu.au
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