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Non-Interventional Clinical Studies

ATORG001 – Molecular Profiling Project
Status Recruiting

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.

Click here to join as a site to contact our project manager.

Status Recruiting

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.

Click here to join as a site to contact our project manager.

Status Completed

This pilot study involves the development of individualized ctDNA profile and utility of ctDNA monitoring in patients with Stage III 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 specimens; generating individualized 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.

Status Completed

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. 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.

Status Upcoming

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 the ATORG network. 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.

Atorg Clinical Study Model

Recent advances in medical science have led doctors and scientists to recognize that lung cancer is diverse and made up of molecular subsets of diseases. Work has begun to identify these sub-types of cancer so that collaborative studies can be initiated to uncover the types of treatment that can benefit each subgroup of patients.

Clinical Trials

Status Ongoing

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 has enrolled 118 subjects which will 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.