Clinical trials 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.
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
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: Phase 2 trial of alternating osimertinib with gefitinib in patients with EGFR-T790M mutation positive advanced non-small cell lung cancer
Clinical trial design: Single arm Phase II clinical trial
Indication: EGFR-T790M mutation positive advanced non-small cell lung cancer patients who have received prior therapy with an EGFR-TKI
Intervention: Osimertinib 80 mg daily for 8 weeks (Induction Phase).
Gefitinib 250 mg daily for 4 weeks then Osimertinib 80 mg daily for 4 weeks, and continue alternating (i.e. alternating 4 weekly cylces of each drug) until disease progression or unacceptable toxicity (Alternating Phase).
Following disease progression and if deemed appropriate by the treating Investigator, continuation of alternating therapy OR continuous Osimertinib 80 mg daily until further progression or unacceptable toxicity (Post-Progression Phase).
Summary: The primary purpose of this clinical trial is to measure the duration before progression when patients with EGFR-T790M mutation positive advanced non-small cell lung cancer are treated with osimertinib and gefitinib. It is hypothesised that alternating therapy with the gefitinib and osimertinib will modulate the populations of EGFR-T790M positive and negative tumour clones, delaying the emergence of resistance to osimertinib.
All participants enrolled in this clinical trial will begin with induction therapy which involves taking an osimertinib tablet once per day for eight weeks. Participants will then move onto the alternating phase, which involves alternating four-weekly cycles of treatment with gefitinib and osimertinib (i.e. four weeks gefitinib then four weeks osimertinib) until disease progression or unacceptable side effects. Following progression, some participants may be eligible to continue with alternating treatment or switch to continuous osimertinib treatment until further progression.
All patients will be reviewed up to every four weeks by blood samples, CT scans and side effect assessments.
Status: Follow up
Closed to recruitment: 12/6/19
Final recruitment number: 49
Endorsed clinical trials
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
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Thoracic Oncology Group of Australasia is registered with the Australian Taxation Office as an Income Tax Exempt Charitable Entity. Donations $2 and over are tax deductible.