ALTG Clinical Trial News
Recently presented at the American Society for Clinical Oncology Annual Scientific Meeting on June 1-5 in Chicago, the The DREAM study (ALTG 15/004) led by Professor Anna Nowak and her team, was again selected for oral presentation at the WCLC Annual Congress on September 23-26 in Toronto, Canada. DREAM is evaluating the activity, safety and tolerability of the combination of durvalumab with chemotherapy in patients with mesothelioma. DREAM completed the enrolment phase of 54 patients ahead of schedule. Early results revealed durvalumab as first line treatment with cisplatin and pemetrexed having higher rates of six month progression free survival (PFS6) and overall response rate (ORR) than expected for chemotherapy alone, with acceptable tolerability. The final result of PFS6 for all 54 patients will be reported in late 2018. A phase III clinical trial is currently in discussion. A follow up phase 3 DREAM trial is in discussion and expected to follow.
The STIMULI study (ALTG 16/012) is a randomised open-label phase 2 trial of consolidation with nivolumab and ipilimumab in limited-stage SCLC after chemo-radiotherapy led by Associate Prof. Paul Mitchell and has recently opened for enrolment. 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 BR.34 study (ALTG 15/004), a phase 2 placebo-controlled randomised trial of durvalumab and tremelimumab ± platinum doublet chemotherapy in the treatment of advanced NSCLC led locally by Associate Prof. Brett Hughes is open for recruitment with 20 sites for enrolment followed by the BR.31 study (ALTG 14/001) led by Associate Prof. Sue-Anne McLachlan, is a phase 3 placebo controlled randomised trial of adjuvant durvalumab in completely resected NSCLC is also recruiting at 27 sites. 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.
The NIVORAD study (ALTG 14/002), a phase 2 placebo-controlled randomised trial of nivolumab ± radiotherapy in the treatment of advanced NSCLC is recruiting at 17 sites. A recent protocol amendment relaxes the inclusion criteria; tissue requirements for PDL1 should (previously must) be available for PD-L1 testing and; a change to the definition of first line of prior therapy – relapse within 12 months of completing curative-intent platinum-based chemotherapy given either as adjuvant to surgery or as concurrent or sequential chemo-radiotherapy is considered one line of chemotherapy. This is a valuable opportunity for patients with advanced NSCLC to have access to nivolumab.
The OSCILLATE study of alternating osimertinib and gefitinib in patients with EGFR T790M positive NSCLC) led by Professor Ben Solomon is recruiting patients at 14 sites and is ahead of schedule. The primary purpose of this trial is to evaluate the efficacy, safety and feasibility of osimertinib and gefitinib for the treatment of EGFR-T790M mutation positive advanced non-small cell lung cancer.
The PEARL study (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. Strategies to boost enrolment at 13 sites are underway to improve enrolment in this important trial. 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 trial 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. HREC has recently been received for this study.
The ALKTERNATE (ALTG 16/007) study 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.