> Ongoing Research
Non- Interventional Clinical Studies
ATORG001 – Molecular Profiling Project
ATORG is undertaking a comprehensive molecular profiling of “actionable” alterations in lung cancer specimens in order to determine the prevalence of each genetic subtype. These mutations are screened using the Oncomine Focus Assay, where 52 genetic alterations – including hotspots, single nucleotide variants, indels, CNVs, and gene fusions – may be detected in a single workflow. In addition, relevant baseline clinical characteristics are collated e.g. patient demographics, smoking history, number of lines of therapy, as well as outcomes including access to targeted therapies, immune checkpoint inhibitors and overall survival. Through comprehensive annotation of clinical-pathological-molecular characteristics, this study will provide a means to rationalize the application of diagnostic tests, as well as identify prognostic and predictive factors in the treatment of Asian lung cancers.
This 2020, ATORG001- Molecular Profiling Project will be initiating a Virtual Molecular Tumour Board which aims to improve physician interpretation and understanding of NGS reports, and facilitate enrolment on clinical trials or access to targeted therapies for rare molecular subtypes. The virtual multidisciplinary molecular tumour board will be organised quarterly, with the first session in April 2020.
ATORG004 – Molecular Profiling in ALK Inhibitor Resistant, ALK Positive Non-Small-Cell Lung Cancer
This study will utilize a non-invasive test to achieve contemporaneous tumour resistance results, which may ultimately guide subsequent treatment selection. This comprehensive molecular profiling with the GUARDANT360 assay will test for 73 genetic alterations (including point mutations, copy number variants, fusions and indels) in a single workflow. Key clinical information, such as patient demographics, prior oncological treatments and treatment outcomes will be collected. Through this process, this sub-study will provide a better understanding of ALK resistance in the treatment of Asian lung cancers and allow for improved clinical outcomes by ‘matching’ any secondary mutations to specific ALK inhibitors (ALKi) that allow for the greatest sensitivity, and may ultimately lead to improved survival.
A Longitudinal ctDNA Monitoring in Stage lll NSCLC (Signatera™)
This pilot study involves the development of individualised ctDNA profile and utility of ctDNA monitoring in patients with Stage lll NSCLC. With a small study population of 10, this study aims to determine the feasibility of performing whole-exome sequencing (WES) on FFPE lung biopsy specimen; generating individualised ctDNA profile at baseline using Natera Assay; concordance of plasma ctDNA profile at baseline with WES from biopsy and the utility of peripheral blood ctDNA for the detection or quantification of patients’ changes in ctDNA during and after treatment.
ATORG003 – A single-arm, open-label, Phase 2 study of Dacomitinib with or without dose titration for the first-line treatment of locally advanced or metastatic non-small cell lung cancer in subjects with an epidermal growth factor receptor (EGFR) activation mutation
This is a multi-national, multi-centre, single-arm, open-label, Phase 2 clinical study of the efficacy and safety of first-line treatment with dacomitinib, with or without dose titration, in subjects with newly diagnosed stage IIIB/IV or recurrent NSCLC. All subjects will have tumors that test positive for at least one EGFR activating mutation, either exon 19 deletion or exon 21 L858R mutation. All tumors will be of histo- and/or cytopathology consistent with adenocarcinoma or its pathologically accepted variants. This study aims to enrol approximately 118 subjects which receive therapy until disease progression, new systemic anticancer therapy instituted, intolerable toxicities, withdrawal of consent, death, or investigator decision dictated by protocol compliance, whichever occurs first.
> Project Pipeline
ATORG005 – Pan- Asian Database of Advanced KRAS Mutant NSCLC
This study aims to comprehensively characterise the epidemiology and clinical management of Asian advanced KRAS mutant NSCLC patients by systematically collecting demographic (such as age, gender, smoking status) and clinicopathologic features, molecular profiles, treatment histories and survival outcomes. This will also provide a better understanding in the longitudinal disease course of specific KRAS molecular subsets of KRAS mutant lung cancer patients in Asia. This study consists of a retrospective cohort of patients, with an approximate cohort size of 200 among 6-8 different sites in Asia.