What is OCEANiC?
The TOGA OCEANIC study follows on from the ADAURA study which showed a significant improvement in DFS and OS compared to placebo.
OCEANiC is a phase II multi-centre clinical trial targeting patients with resected stage II to IIIA EGFR mutant NSCLC. The trial provides access to Osimertinib for all patients with EGFR mutations post-surgery.
This study aims to determine if adjuvant chemotherapy can be omitted in patients with resected stage II-IIIA EGFR mutant NSCLC who are at lower risk of lung cancer recurrence.
How can you support OCEANiC?
There are two ways in which you can support this study:
- Referring potentially eligible patients to the study investigators is greatly appreciated
- Collection of ctDNA and NGS co-mutation samples used to determine risk of recurrence and omission of chemo. These samples need to be collected within 31 days of surgery.
Eligibility
Key inclusion criteria:
- Histological diagnosis of NSCLC (mixed small cell histology is not eligible)
- MRI of the brain performed prior to commencing study treatment
- Stage IIA to IIIA disease according to AJCC 8th edition
- EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R, G719X, etc.), either alone or in combination with other EGFR mutations including T790M.
- Complete surgical resection of the primary NSCLC, including all gross disease surgically removed, and all surgical resection margins negative.
- Complete recovery from surgery at the time of registration.
- ECOG Performance Status of 0 or 1
- Adequate organ system function within 7 days: a) platelets ≥ 100 x 109/L, ANC ≥ 1.5 x 109/L, and haemoglobin ≥ 90g/L; b) liver function; ALT/AST ≤ 2.5 x ULN and total bilirubin ≤ 1.5xULN; c) renal function; serum creatinine ≤ 1.5xULN.
Key exclusion criteria:
- Post-operative radiotherapy (PORT) planned
- Prior radiation to lung and/or mediastinum
- Prior EGFR pathway inhibitor treatment
- Known history of hypersensitivity or contraindication to Osimertinib, recommended chemotherapy or excipients
- Specific comorbidities or conditions (e.g. psychiatric) or concomitant medications which may interact with treatment, including: a. Known history of interstitial lung disease or drug-induced pneumonitis requiring steroid treatment. b. Significant history of cardiovascular, peripheral vascular or cerebrovascular disease.
- History of another concurrent active malignancy that requires ongoing treatment.
- Pregnancy, lactation, or inadequate contraception.
NOTE: Blood samples for screening ctDNA must be collected within 31 days of surgery.
How do I refer a patient?
Potential patients need ctDNA collected within 28 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
- 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
- The Prince Charles Hospital – Chermside, QLD
- Fiona Stanley Hospital – Murdoch, WA
- Flinders Medical Centre Bedford Park- SA
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 have any questions about the OCEANiC study, please do not hesitate to contact the OCEANiC team at oceanic.study@sydney.edu.au or find out here.
