Molecular Profiling Project

Study Overview
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Brief Summary
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In this study, the investigators plan to undertake comprehensive molecular profiling of actionable alterations in lung cancer specimens in order to determine the prevalence of each genetic subtype in the local population.

Detailed Description
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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. Oncomine™ Comprehensive Assay v3, an NGS assay which tests for 161 unique genes (Appendix IV), will be used in a later stage of the study, allowing for broader coverage of potentially targetable alterations. Both assays have a rapid turnaround time and addresses one of the main challenges of solid tumor testing - the scarcity of tissue material - requiring minimal sample input and thus enabling the use of a wider range of sample quality and types, including small biopsies and fine needle aspirates. However, as the list of therapeutically relevant biomarkers continues to expand over time, broader NGS panels will be used subsequently to incorporate emerging alterations. 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.

Official Title
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ATORG001 - Molecular Profiling Project

Conditions
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Lung Cancer, Non-Small Cell Lung Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The availability of sufficient archival tumor tissue specimen (15 slides of 4 microns per section) Age ≥ 21 years WHO performance status ≤ 2 Life expectancy of ≥ 12 weeks Patients should have adequate organ function for potential consideration into clinical trials (routine blood tests are valid within 14 days before enrollment): Adequate bone marrow function as shown by: ANC ≥ 1.0 x 10^9/L, Platelets ≥ 75 x 10^9/L, Hb ≥ 7.5 g/dL Alanine aminotransferase (ALT) and aspirate aminotransferase (AST) normal range (or ≤3.0 x ULN if liver metastases are present) Willing to provide signed informed consent Patients whom do not fulfill the above criteria may be discussed on a case-by-case basis with the study team, for potential enrolment Exclusion Criteria: - No more than 3 lines of cytotoxic chemotherapy at the time of enrolment

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molecular profiling of lung cancer specimens | Lung cancer specimens will be collected and profiled at a molecular level to evaluate the molecular epidemiology of NSCLC in Asia | After patient meets the eligibility criteria and consent has been taken | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of patient survival status |  | After molecular profiling has been completed, every few months up to 2 years | 
| Collection of subsequent patient treatment status |  | After molecular profiling has been completed, every few months up to 2 years | 
| Collection of the clinical outcomes of the subsequent treatments the patients receive |  | After molecular profiling has been completed, every few months up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oncomine Focus Panel Assay, Molecular profiling, Targeted therapies, Driver oncogene, Next-Generation Sequencing (NGS), PD-L1 Immunohistochemistry (IHC, Dako 22C3), Hotspots, Single Nucleotide Variants (SNVs), Insertions/ Deletions (Indels), Copy Number Variation (CNVs),, Gene Fusions, Formalin-Fixed, Paraffin Embedded (FFPE) extracted DNA and RNA, Ion PGM™ System, Oncomine™ Comprehensive Assay v3