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.
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.