Clinical Trials

Metastatic spread of cancer from its primary site to distant organs is the commonest cause of death from cancer. The term oligometastases describes an intermediate metastatic state, in which cancer exists as a limited number of metastases at first, before cells acquire the ability to metastasise more widely. For the large majority of solid cancers, once metastatic disease has been diagnosed the chances of cure are small. There are several situations where this is not the case, but it is not known if stereotactic body radiotherapy (SBRT) for oligometastatic disease will alter outcomes or whether the toxicity burden of this treatment is justified. SBRT is targeted radiotherapy which destroys cancer cells in the area of the body it is aimed at however low dose radiation may be received by surrounding tissue. It is difficult to quantify incidence of patients with multiple primary cancers developing at intervals that are representative of oligometastatic stage IV disease, (defined for the purposes of this trial as ≤ 3 metastatic sites). However an increase in the use of surveillance imaging, together with improved diagnostic sensitivity has led to the diagnosis of patients with asymptomatic oligometastatic relapse becoming a more common clinical occurrence. The CORE study is a randomized controlled clinical trial that will be conducted in patients with cancer in one of three primary sites where oligometastatic disease relapse is a common clinical scenario: breast, prostate and non-small cell lung cancer (NSCLC). The clinical trial will evaluate the use of SBRT in this patient population. Eligible patients who consent to participate in this clinical trial will be randomized to receive standard care or standard care plus SBRT.

20-40% of patients with NSCLC will develop brain metastases at some point during their course of the disease. Osimertinib has demonstrated intracranial activity in EFGR mutated NSCLC with leptomeningeal disease in the phase 1 BLOOM study. Stereotactic radiosurgery (SRS) is one of the standard local treatment for patients with limited number of brain metastases. Currently, it is unclear whether adding SRS to Osimertinib will result in superior intracranial disease control in patients with EGFR mutated NSCLC with brain metastases diagnosed de novo or developed while on first line EGFR tyrosine kinase inhibitors (TKIs) such as Erlotinib and Gefinitib. The aim of this clinical trial is to compare the effects of Osimertinib alone versus Osimertinib plus SRS on intra-cranial disease control in EGFR mutated NSCLC with brain metastases diagnosed or developed while on first line EGFR tyrosine kinase inhibitors.

Cancer-related cognitive impairment is a well-recognised problem in cancer patients. However, there is little data that has assessed cognitive function in patients with metastatic disease, warranting further attention as a growing number of people are living with metastatic NSCLC. To understand whether cognitive function is a problem for people who have received, chemotherapy, immunotherapy or targeted therapies, COGNITION aims to investigate self-reported cognitive symptoms in patients living beyond the first 3 months of diagnosis with stage IV NSLC.

CHEST RT is investigating the safety and effectiveness of combining chemotherapy and immunotherapy with chest radiation therapy for the treatment of extensive stage small cell lung cancer (ES-SCLC). For over 20 years, a combination of chemotherapy using etoposide with either cisplatin or carboplatin had been used to treat ES-SCLC. Adding immunotherapy to the chemotherapy combination has been shown to help boosts the body’s natural defences to fight cancer, improving response to treatment. This combination of chemotherapy with immunotherapy is now the standard of care treatment. The immunotherapy used in this study is called durvalumab (IMFINZI). Durvalumab is approved by the Therapeutic Goods Administration (TGA) in Australia as the first-line treatment of patients with ES-SCLC, in combination with etoposide and either cisplatin or carboplatin. Research has shown that radiation therapy also improves the ability of the immune system to recognise tumours. The researchers would like to investigate whether combining radiation therapy with the standard chemo/immunotherapy may further improve patients response to treatment.

LUCAP is a patient-focused research group who are developing a national clinical quality data platform for lung cancer that collects, analyses and reports on information such as how quickly people get lung cancer tests, what sort of tests are done and how quickly people get treatments. When large datasets are analysed, this real world data can provide an indication of quality of advances in lung cancer care. Reports from this platform for individual lung cancer service providers can be compared against a set of national standards to inform of unwanted variation in care, and provide compelling evidence for this to be addressed. The platform can further extend to support innovative research in lung cancer care and treatments.

There is a lack of robust evidence in the successful management of night sweats in patients with mesothelioma. As this is both a common and often debilitating symptom of their cancer, improving the evidence base for the pharmacological management of night sweats will be of great benefit to patients.

This research program will test ways of inviting and educating high-risk people about lung cancer screening. Lung cancer is the number one cause of cancer death worldwide. A screening test using low dose CT could save thousands of lives. The study will invite people, aged between 50 and 80 years and who smoke cigarettes daily or quit less than 15 years ago, via their family doctor.

Previous work has demonstrated that patients with metastatic disease, including mNSCLC, who experience long periods of disease stability have unique survivorship challenges. It is unclear whether such survivorship needs are addressed by community clinicians. The aim of this study is to facilitate and enhance communication between hospital-based cancer care teams, primary care clinicians and patients via the implementation of a multi-disciplinary team (MDT) consultation including both the patient’s GP and the patient to identify the survivorship concerns of individual long-term responder patients with mNSCLC and formulate a tailored survivorship care plan.

Radiation therapy (RT) is indicated for 77% of lung cancer patients. A common adverse event, affecting at least 20% of patients, is radiation-induced lung injury. To minimise radiation-induced lung injury, Professor Keall’s team has invented and pioneered ventilation imaging based on computed tomography (CT) which has been developed into a medical device (CIA). This medical device uses CT scans routinely acquired for planning RT to compute a CT ventilation map showing high functioning and low functioning lung regions. VitAL aims to investigate whether the use of CIA can be used to direct radiation away from the healthy, high functioning regions towards the low functioning regions, thereby reducing toxicity and improving the patient’s quality of life.

Cancer Related Fatigue (CRF) is one of the most prevalent, persistent and distressing patient-reported symptoms associated with cancer and its treatment. Physical activity (PA) and psychosocial interventions targeted specifically for CRF have independently been shown to reduce CRF, with more robust evidence supporting PA. Mindfulness Based Stress Reduction (MBSR) is an emerging strategy to address a number of conditions, such as depression and Chronic Fatigue Syndrome. The aim of this study is to determine if a combined PA and MBSR intervention is active in improving CRF in cancer survivors.

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.

The Victorian Lung Cancer Registry is a Clinical Quality Registry established in 2011 and housed in the Clinical Registry Unit, Monash University. With governance oversight and nationally-based opt out ethical consent, the VLCR has recruited 44 hospitals from 19 health services representing over 85% of Victorian lung cancer diagnoses and registered 11,000 lung cancer patients providing both a Quality Indicator Report and an Annual Report to stakeholders with the objective of driving Quality Improvement through gap analysis and local on-site innovation.

There are no available population-level clinical or patient-reported outcomes or treatment data for people living with mesothelioma in Victoria (or Australia). We do not know how many people are offered immunotherapy or other active treatments, nor do we have any insights into patient outcomes or their experiences of care. This research is designed to address this critically important unmet need. Aim: To understand patterns of care and the use of immunotherapy in patients with malignant mesothelioma (MM). Furthermore, the study aims to collect the patient-reported experience of care and their quality of life to inform a learning health system model to drive patient-centred improvements in quality of care.

Approximately one third of lung adenocarcinomas are driven by mutations in the oncogene Kirsten Rat Sarcoma Virus (KRAS). Immunotherapy has improved survival outcomes compared with standard chemotherapy both as a monotherapy, and in combination with chemotherapy. Approximately 20% of KRAS mutant lung cancers do not respond to immunotherapy due to co-occurring mutations in other genes. To enhance response to immunotherapy, combination treatments tailored for these tumours are needed. This research project aims to test whether using drugs specifically tailored to inhibit KRAS, in combination with immunotherapy in a laboratory setting, will provide evidence to suggest this approach is further assessed through clinical trials. This study also aims to identify novel drug targets to increase treatment options, and has the potential to identify new treatment regimens for improved survival in high-risk lung cancer patients.

This project will conduct early stage, small scale research, to assess the potential and feasibility of developing the first Australian Tissue Repository of Airway Cancers for Knowledge Expansion of Resistance (TRACKER) to address issues in translational lung cancer research. Since 2015, immunotherapy has emerged as a promising treatment, however 95% of patients will develop resistance. Conventional tissue sampling and analysis often means the opportunity to study mechanisms of immunotherapy resistance in tissue samples is not maximised. This study aims to establish a clinically annotated biobank of tissue samples from patients with metastatic lung cancer that can be harnessed to advance knowledge in immunotherapy resistance. This will provide a platform for mechanism-driven therapeutic pre-clinical and clinical studies, to enhance personalised medicine approaches.

This study aims to survey institutions treating lung cancer patients across ANZ regarding key workforce and infrastructure availability. Institutions will also be queried on access to contemporary and novel therapeutics, and other aspects of clinical care such as availability of MDT meetings, smoking cessation and access to clinical trials.

Currently the standard of care in unresectable stage III NSCLC is concurrent chemoradiotherapy followed by consolidation durvalumab. This is regardless of the patient’s PD-L1 expression or oncogenic driver mutation status. This descriptive study employing a survey of current practices aims to determine patterns of Durvalumab prescribing in Australia in patients with stage IIIB unresectable non-small cell lung cancer. The ultimate goal is to aid in standardising cancer care in Australia

Lung cancer patients expect to feel breathless, and little is done to implement therapies to address this symptom. Without management breathlessness negatively impacts physical function, social and psychological wellbeing. Despite there being evidence-based interventions to support people there remains a gap in implementation. This project will investigate existing datasets and co-design a study to determine current practice and potentially lead to implementation research or clinical trials to improve the translation of research evidence to manage breathlessness in lung cancer patients.

Immunotherapy has improved outcomes in patients with metastatic non-small cell lung cancer (NSCLC) without an actionable driver mutation, when compared to chemotherapy alone. Since 2018 immunotherapy agents were approved for first-line use either as a single-agent immunotherapy (ICI) or in combination as chemoimmunotherapy (CIT) for patients with metastatic NSCLC and programmed death ligand-1 (PDL1) score greater than or equal to 50%. The addition of chemotherapy to immunotherapy is hypothesised to improve the immunogenicity of the tumour micro-environment and induce a more rapid tumour response. However the addition of chemotherapy risks greater toxicity. There remain a limited number of international real-world analyses that assess characteristics influencing treatment selection and none in the Australian setting. There are no descriptive analyses of current practice for this cohort in Australia. This study aims to administer a survey to clinicians in order to understand current clinical practice and treatment decision-making for driver-negative, metastatic NSCLC with PDL1 50% or greater.

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)

The use of circulating tumour DNA as liquid biopsies in cancer care is rapidly expanding.  ctDNA has many potential advantages as it is non-invasive and potentially more efficient and less-costly compared to tissue genotyping.  Accurate genotyping of lung cancer is of particular interest in the Australia/NZ due to high rates of targetable mutations in cancers, especially in the Māori and Pacific population^{1, 2}.  Furthermore, this technology can improve diagnostic and cancer monitoring in rural communities, where access to hospital-based services can be limited.  Data on the current usage and barriers to implementation is needed to support its use in clinical practice. This study aims to survey assess the current usage of ctDNA in clinical practice and identify barriers to implementation in the Australia/NZ.