> upcoming Research
Non- Interventional Clinical Studies
ATORG006 – Pan-Asian clinical database of EGFR exon20 insertion mutated non-small cell lung cancer (NSCLC)
This study aims to comprehensively characterize the epidemiology and clinical outcomes of Asian advanced EGFR exon 20 insertion mutated NSCLC patients. In addition, an enhanced understanding of the prognostic and predictive influence of EGFR exon 20 insertion variants, and mechanisms of resistance to novel EGFR targeted therapies will be elucidated.
This will be a multi-centre observational and translational study of advanced EGFR exon 20 insertion mutated NSCLC patients at sites in Asia. Patients will be both retrospectively and prospectively enrolled, with prospective genomic profiling of plasma and tumor tissue from baseline and at the time of resistance where feasible. Key demographic, clinicopathology, treatment (including subsequent therapies) and survival data will be collected.
> 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.
ATORG001 – Molecular Profiling Project has also initiated 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 has been organised quarterly ever since the first session held 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 74 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.
ATORG005 - Pan- Asian Database of Advanced KRAS Mutant NSCLC
This study aims to comprehensively characterize the epidemiology and clinical management of Asian advanced KRAS mutant NSCLC patients by systemically 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. The study was completed in 2021; an article titled “Clinical Characteristics and Outcomes in Advanced KRAS-Mutated NSCLC: A Multicenter Collaboration in Asia (ATORG005) was published in the JTO Clinical and Research Reports on 04 December 2021.
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
Status: Active, recruitment complete
This is a multi-national, 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/IIIC/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. This study has met its enrolment target of 118 subjects who will receive therapy until disease progression, new systemic anticancer therapy instituted, intolerable toxicities, withdrawal of consent, death, or 36 months from first dose, whichever occurs first.