Clinical research in lung cancer and mesothelioma
The TOGA clinical trial and research program spans early and advanced non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), mesothelioma, other thymic malignancies, supportive & palliative care and translational research. Successful collaborations for clinical trials have been established within Australia and in North America, Asia and Europe. TOGA has a long-standing collaboration with the National Health and Medical Research Council Clinical Trials Centre (NHMRC CTC) that has provided exemplary conduct of their clinical trials both locally, and internationally.
TOGA seeks to endorse high-quality thoracic cancer clinical research to increase lung cancer research capacity, to provide peer-review to maximise feasibility and scientific merit and to maximise collaborations between the multiple disciplines involved in the treatment of thoracic cancers.
Endorsed proposals enable the use of the TOGA logo on research applications and TOGA will promote your research across their communications platforms where feasible.
Clinical research proposals are reviewed at working groups, which are conducted approximately four times per year. In advance of a working group meeting, TOGA will call for proposals via membership newsletters and social media. Following working group meetings, the TOGA Scientific Committee will approve endorsement of a research proposal.
Access additional resources and read more about TOGA’s research development and endorsement process.
Clinical trials open to recruitment
Title: DREAM3R – DuRvalumab (MEDI4736) with chEmotherapy as first line treAtment in advanced pleural Mesothelioma – A phase 3 Randomised trial
Clinical trial design: Open-label Phase III randomised clinical trial
Indication: Newly diagnosed unresectable malignant pleural mesothelioma
Intervention: First-line treatment with standard chemotherapy of pemetrexed and cisplatin. Two-thirds of the participants in the study will be randomly assigned to also receive durvalumab (immunotherapy).
Summary: The DREAM3R clinical trial is determining the effectiveness of adding durvalumab to standard first line chemotherapy with cisplatin and pemetrexed in advanced malignant pleural mesothelioma and identifying potential and prognostic biomarkers from blood and tissue.
Durvalumab is an antibody (a type of human protein) that works by blocking a body substance called Programmed Death-Ligand 1 (PD-L1). Blocking PD-L1 helps the body’s immune system attack cancer cells. Research has shown that durvalumab can slow tumor growth and shrink tumors in some people with cancer. Previous studies of combining durvalumab and chemotherapy showed that this combination is active in advanced mesothelioma.
A recent amendment (2022) to this trial will enable patients randomised to standard of care to have a choice (made in consultation with the treating physician) that includes ipilimumab (ipi) and nivolumab (nivo), the dual immunotherapy combination on the PBS, rather than just chemotherapy alone. This combination immunotherapy targets a similar pathway to Durvalumab but using different targets. Ipi binds to CTLA-4 and nivo binds to PD1. This amendment means that mesothelioma patients on this clinical trial will have immunotherapy available in both arms.
It is hoped this research will demonstrate that durvalumab is safe and effective for the treatment of advanced mesothelioma, and that the results of this clinical trial will lead to improved outcomes for future mesothelioma patients.
Recruitment target: 480
This study is a collaboration with PrECOG in the USA.
Clinical trials in follow up
Title: ASPIRATION- An observational cohort study to assess the clinical impact of comprehensive genomic profiling in metastatic lung cancer patients
Study design: Observational cohort study
Indication: Newly-diagnosed metastatic non-squamous non small cell lung cancer (NSCLC)
Intervention: Comprehensive genomic profiling to identify actionable biomarkers to guide therapy
Summary: The ASPiRATION study is investigating the clinical impact of comprehensive genomic profiling (CGP) on the management of metastatic NSCLC and assessing the feasibility of CGP implementation nationally.
In Australia, standard of care tumour testing for lung cancer patients has the ability to identify changes in three genes: EGFR, ALK & ROS1, for which drugs are available on the Pharmaceutical Benefits Scheme (PBS).
If a patient is suitable for ASPiRATION, their tumour will also be tested using CGP, often referred to as molecular screening and/or profiling. This technique allows treating clinicians to look at changes in hundreds of genes in a single test. After a patient’s tumour is tested, a report is sent to the referring oncologist with information on (i) Any genetic biomarkers that were identified in the tumour and (ii) The types of treatment that may be suitable.
It is hoped this research will determine whether additional molecular screening can be feasibly integrated into Australian clinical practice for patients with metastatic NSCLC.
Recruitment target: 1000
Status: Recruitment complete
The ASPiRATION study is led by TOGA, in collaboration with Omico (Australian Genomic Cancer Medicine Centre) and the NHMRC Clinical Trials Centre (CTC).
Endorsed clinical research
Title: CHEST RT: Chemotherapy and Immunotherapy in extensive stage small cell lung cancer with thoracic radiotherapy
Collaboration with: Trans Tasman Radiation Oncology Group (TROG) Trial 20.01
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.
Recruitment target: 35
Title: RAPID series for night sweats in malignant mesothelioma
Lead Researcher: Dr Alannah Jackson and Prof Anna Nowak, Sir Charles Gairdner Hospital
Recruitment target: 300
Title: Australasian Landscape Survey of Lung Cancer Care
Lead Researcher: Prof Fraser Brims