Clinical Trials

20/007 OCEANiC

OCEANiC – Osimertinib plus Chemotherapy Evaluation in Adjuvant NSCLC incorporating CtDNA.

Recruitment target:

100

Status:

Open to Recruitment

Summary:

OCEANiC will investigate whether, following surgery for local or locally advanced EGFR+ NSCLC, patients with tumours containing certain types of genetic signatures can achieve the same disease-free survival with osimertinib treatment alone, as has previously been achieved with osimertinib and chemotherapy. Standard of care treatment is evolving to include osimertinib in addition to chemotherapy, but the OCEANiC trial may provide evidence for similar benefits for using the drug alone, with less toxicity, improved quality of life and reduced health care costs.

Clinical trial design:

Phase II, open-label, multi-centre clinical trial.

Indication:

Patients With Stage IIA-IIIA EGFR-Mutant Non Small Cell Lung Cancer Following Complete Surgical Resection.

Intervention:

All participants receive osimertinib 80 mg orally, once daily, for up to 3 years or until disease recurrence, unacceptable toxicity or consent withdrawal, whichever is sooner. Cohort 2 participants also receive 4 cycles of chemotherapy.

More information:

For patients

For clinicians

Contact: oceanic.study@sydney.edu.au

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Open to Recruitment:

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23/008 ASPECT

The aim is to establish the rates of radiation-induced lung disease outcomes, quality of life, and progression-free survival in lung cancer patients treated with Functional avoidance radiotherapy (Arm 1) and Standard radiotherapy (Arm 2)

Open to Recruitment

22/001 DYNAMALK

Eventual resistance to ALKi therapy remains inevitable. There is currently no predictive or prognostic biomarker accepted or available in routine clinical practice to guide the personalised management of advanced ALK+ cases from diagnosis and with each line of therapy, nor is there wide and timely accessibility of a ctDNA genomic panel to enable such molecular data in Australia. DYNAMALK aims to undertake molecular profiling via an Australian ctDNA study in treatment naïve and pre-treated ALK+ patients to describe and correlate ctDNA findings according to any prior therapies and temporal genomic profiles of patients recruited, to identify patterns of emerging resistance against clinical outcomes, and to report the influence of ctDNA genomic data obtained real time in informing clinical management over and above standard of care.

Open to Recruitment

20/004 ALK ASPiRATION SUBSTUDY

A single arm, open label, phase II trial of alectinib in patients with advanced tumours harbouring ALK gene alterations detected by comprehensive genomic profiling (CGP) (MoST 14).

Open to Recruitment

20/001 HER2 ASPiRATION SUBSTUDY

The HER2 ASPiRATION substudy intends to demonstrate activity of trastuzumab emtansine in advanced HER2+ metastatic NSCLC. Trastuzumab emtansine is a drug known as an antibody drug conjugate (ADC) consisting of a monoclonal antibody trastuzumab, to target the tumour, that is covalently linked to the cytotoxic agent DM1. This drug has demonstrated efficacy in HER2+ breast cancer.

Open to Recruitment

21/011 SHERLOCK

SHERLOCK will examine whether sotorasib used in first line treatment of advanced KRAS G12C+ NSCLC, in combination with two chemotherapy drugs (called carboplatin and pemetrexed) and bevacizumab (which improves anti-cancer drug delivery) improves the response of the tumour to treatment. Sotorasib is available on the PBS as monotherapy in 2^nd or later lines of treatment. Patients with advanced KRAS G12C+ NSCLC usually undergo initial treatment with chemotherapy, immunotherapy or a combination of the two treatments.

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