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: 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
Information sheet for clinicians
The ASPiRATION study is led by TOGA, in collaboration with Omico (Australian Genomic Cancer Medicine Centre) and the NHMRC Clinical Trials Centre (CTC).
Clinical trials in follow up
Title: ALKTERNATE A single arm multi-centre translational proof of concept study investigating the safety and efficacy of alternating lorlatinib with crizotinib in a pre-treated advanced ALK-rearranged non small cell lung cancer (NSCLC) population with disease progression on a 2nd generation ALK tyrosine kinase inhibitor
Clinical trial design: Open-label Phase II single arm clinical trial
Indication: ALK-rearranged advanced NSCLC any number of lines of prior therapy with the immediately prior treatment a second generation ALK inhibitor
Intervention: All participants enrolled in this clinical trial will begin with Induction therapy which involves taking lorlatinib tablets every day for 12 weeks. Participants will then move onto the Alternating phase. During the Alternating phase participants will take crizotinib for 4 weeks, then lorlatinib for 8 weeks, then crizotinib for another 4 weeks, and lorlatinib for 8 weeks until disease progression or unacceptable side effects.
Summary: The primary purpose of this clinical trial is to evaluate the efficacy, safety and feasibility of alternating lorlatinib and crizotinib for the treatment of ALK-rearranged advanced NSCLC.
All participants enrolled in this clinical trial will begin taking lorlatinib tablets every day for 12 weeks. Participants will then move onto the Alternating phase. During the Alternating phase participants will take crizotinib for 4 weeks, then lorlatinib for 8 weeks, then crizotinib for another 4 weeks, and lorlatinib for 8 weeks until disease progression or unacceptable side effects. Following progression, some participants may be eligible to continue with alternating treatment or switch to continuous lorlatinib treatment until further progression, depending on whether your doctor believes that this would be of benefit to you.
All patients will be reviewed up to every four weeks clinically, with bloods tests, CT scan and MRI (brain) and side effect assessments.
It is hoped that the findings from this clinical trial will provide information on whether alternating treatment with crizotinib and lorlatinib is feasible, safe and effective for the treatment of ALK-rearranged advanced NSCLC with the potential to delay the emergence of drug resistance as compared to continuous lorlatinib therapy alone.
Recruitment target: 25
Status: Recruitment completed
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
Clinical trial design: Single arm open label prospective multicentre Phase II clinical trial
Indication: Extensive Stage Small Cell Lung Cancer
Intervention: Durvalumab, chemotherapy (cisplatin/carboplatin and etoposide) and thoracic radiation therapy
Summary: 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.
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
Clinical trial design: A multi-centre, prospective consecutive cohort study. Data is collected by the clinician on day 0, day 7 and day 14 post-intervention commencement using a detailed custom data collection form.
Summary: 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.
Recruitment target: 300
Status: In progress