Clinical trial NCT04025515: Molecular Profiling Project
Official title: ATORG001 - Molecular Profiling Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Non-Small Cell Lung Cancer
Keywords: 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
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
Collaborators: name: Singapore General Hospital
First posted: 2019-07-19
Enrollment: 500
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asian patients with Non-Small Cell Lung Cancer (NSCLC)

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Molecular profiling of lung cancer specimens
timeFrame: After patient meets the eligibility criteria and consent has been taken
Secondary outcomes:
measure: Collection of patient survival status
timeFrame: After molecular profiling has been completed, every few months up to 2 years
measure: Collection of subsequent patient treatment status
timeFrame: After molecular profiling has been completed, every few months up to 2 years
measure: Collection of the clinical outcomes of the subsequent treatments the patients receive
timeFrame: After molecular profiling has been completed, every few months up to 2 years
Other outcomes:
Locations:
city: Brunei
country: Brunei Darussalam
facility: The Brunei Cancer Centre
city: Hong Kong
country: Hong Kong
facility: Hong Kong Integrated Oncology Centre
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong, Department of Clinical Oncology
city: New Delhi
country: India
facility: Rajiv Ghandhi Cancer Institute and Research Centre
city: Kuala Lumpur
country: Malaysia
facility: Pantai Hospital, Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre, Clinical Oncology Department
city: Penang
country: Malaysia
facility: Penang Adventist Hospital
city: Petaling Jaya
country: Malaysia
facility: Beacon Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
Study officials:
affiliation: National Cancer Centre, Singapore
name: Daniel Tan, BSc, MBBS, MRCP
role: PRINCIPAL_INVESTIGATOR
References: