Molecular Profiling Project

Recruiting

• Conditions: Non-Small Cell Lung Cancer; Lung Cancer

• Registration Number: NCT04025515
• Lead Sponsor: National Cancer Centre, Singapore

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.

Study Timeline

• Study Start: 2019-01-11
• Study First Submitted: 2019-06-15
• Study First Submitted QC: 2019-07-18
• Study First Posted: 2019-07-19
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01
• Primary Completion: 2024-12-25
• Study Completion: 2025-12-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Collection of subsequent patient treatment status	After molecular profiling has been completed, every few months up to 2 years
Collection of patient survival 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

Trial Locations

Locations (10)

Hong Kong Integrated Oncology Centre; 🇭🇰 Hong Kong, Hong Kong

Rajiv Ghandhi Cancer Institute and Research Centre; 🇮🇳 New Delhi, India

Beacon Hospital; 🇲🇾 Petaling Jaya, Malaysia

The Chinese University of Hong Kong, Department of Clinical Oncology; 🇭🇰 Hong Kong, Hong Kong

Pantai Hospital, Kuala Lumpur; 🇲🇾 Kuala Lumpur, Malaysia

National Cancer Centre Singapore; 🇸🇬 Singapore, Singapore

The Brunei Cancer Centre; 🇧🇳 Brunei, Brunei Darussalam

University Malaya Medical Centre, Clinical Oncology Department; 🇲🇾 Kuala Lumpur, Malaysia

Penang Adventist Hospital; 🇲🇾 Penang, Malaysia

Phramongkutklao Hospital; 🇹🇭 Bangkok, Thailand