Clinical Trial News
The DREAM study (ALTG 15/004) led by Professor Anna Nowak and her team, provided an opportunity for patients with malignant pleural mesothelioma (MPM) to receive immunotherapy combined with first-line chemotherapy, and quickly concluded patient enrolment. An abstract to present DREAM’s early data was submitted to the 2108 American Society Clinical Oncology (ASCO) Congress in Chicago held in June, along with over 6,400 abstract submissions and we’re excited to announce that DREAM was selected for oral presentation. This is news is exciting news because it provides Professor Nowak the platform to highlight not only ALTG’s research capabilities but also the benefits of combined therapy applications for patients with MPM. A follow up phase 3 DREAM trial is expected to follow.
ALKTERNATE (ALTG 16/007) led by Associate Prof. Nick Pavlakis, is a randomised phase 2 study of fixed alternating crizotinib/lortatinib versus sequential crozotinib followed by lortalinib, as first line therapy in ALK gene rearranged NSCLC. It has been submitted for MRFF grant which is focussed on rare and low survival cancers. The trial is a proof of concept mainly to identify whether a fixed alternating schedule of crizotinib followed by lorlatinib followed by crizitinib and so on, will result in greater disease control and suppression of detectable innate or acquired ALK gene resistance mutations in blood than the approach of continuing crizotinib until clinical progression then switching to lorlatinib.
The BR.34 study (ALTG 15/004), a phase 2 placebo-controlled randomised study of nivolumab ± radiotherapy in the treatment of advanced NSCLC led locally by Associate Prof. Brett Hughes has quickly opened 14 out of 22 sites for enrolment followed by the NIVORAD study (ALTG 14/002), a phase 2 placebo-controlled randomised study of nivolumab ± radiotherapy in the treatment of advanced NSCLC has opened 12 out of 25 sites; site activation for both trials is ongoing. This is a valuable opportunity for patients with advanced NSCLC to have access to nivolumab.
Recruitment to BR.31 (ALTG 14/00) also led by Associate Prof. Brett Hughes, is a phase 3 placebo controlled randomised study of adjuvant durvalumab in completely resected NSCLC continues to progress. It is critical for this study that all patients who are being treated surgically are considered for eligibility. This can be best done through the MDT with the support of the lung cancer care coordinator, if available at your site.
PEARL (ALTG 13/008 ) is a randomised phase 3 trial of early referral to palliative care for patients with advanced thoracic malignancies led by Associate Prof. Linda Mileshkin. A recent trial committee meeting re-reviewed Palliative care “script” on introducing the study and provided more guidance to sites with positive results. Quarterly calls with similar forum, or more focussed calls with sites to discuss the collaboration required between Palliative Care, Respiratory Care, and Medical Oncology groups.
The ILLUMINATE (ALTG 16/009) study is a Phase 2 study of durvalumab plus tremelimumab in patients with relapsed EGFR mutant non-small a trial of durvalumab and tremelimumab with chemotherapy in non-squamous non-small cell lung cancer (NSCLC). The aim of this trial led by Dr Chee Lee, is to evaluate the efficacy and tolerability of combination durvalumab plus tremelimumab in patients with relapsed EGFR mutant NSCLC. Feasibility for this trial will begin in mid-May.
The STIMULI trial (ALTG 16/012) led by Associate Prof. Paul Mitchell is a randomised open-label phase 2 trial of consolidation with nivolumab and ipilimumab in limited-stage SCLC after chemo-radiotherapy. The purpose is to evaluate if patients treated with chemo-radiotherapy and PCI followed by consolidation treatment (nivo+ipi) have a better outcome (progressive-free survival and overall survival) compared to patients treated with chemo-radiotherapy and prophylactic cranial irradiation (PCI) alone.
The Australasian Tele-trial Model has been developed by the Clinical Oncology Society of Australia (COSA) Regional and Rural Group in consultation with clinical trial sponsors, clinicians, health administrators and regulatory bodies. The ALTG, among other Collaborative Clinical Trials Groups (CCTG) is a member of the advisory group to help prepare for the adoption of the Tele-trial model within the collaborative groups. Tele‐oncology models of care have been shown to satisfy many specialist health care needs of rural and regional patients in countries with large rural populations. Tele‐oncology models of care may outline a system‐level intervention to address issues of equity and access to clinical trials. The ALTG will consider the applicability of this model in future trials. Visit www.cosa.org.au for further information about the Tele-trial model.