Molecular profiling of lung cancer specimens

ATORG001 - Molecular Profiling Project

This study is testing how common different genetic changes are in lung cancer patients to help find better treatments and improve survival.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: National Cancer Centre, Singapore (other)
• Drugs / interventions: chemotherapy
• Locations: 10 sites (Brunei and 9 other locations)
• Trial ID: NCT04025515 on ClinicalTrials.gov

What this trial studies

This project focuses on comprehensive molecular profiling of actionable alterations in lung cancer specimens to determine the prevalence of genetic subtypes in the local population. The Oncomine Focus Assay will be utilized to detect 52 genetic alterations, while the Oncomine Comprehensive Assay v3 will later expand the analysis to 161 unique genes. The study aims to address challenges in solid tumor testing by requiring minimal tissue input, thus enabling the use of various sample types. Additionally, clinical characteristics and outcomes will be collected to enhance the understanding of targeted therapies and patient survival.

Who should consider this trial

Good fit: Ideal candidates include adults aged 21 and older with sufficient archival tumor tissue and a WHO performance status of 2 or less.

Not a fit: Patients who have received more than three lines of cytotoxic chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the identification of targetable genetic alterations in lung cancer, leading to more personalized treatment options for patients.

How similar studies have performed: Other studies utilizing molecular profiling and next-generation sequencing have shown promise in identifying actionable mutations in cancer treatment.

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

Where this trial is running

Brunei and 9 other locations

• The Brunei Cancer Centre — Brunei, Brunei Darussalam (RECRUITING)
• Hong Kong Integrated Oncology Centre — Hong Kong, Hong Kong (RECRUITING)
• The Chinese University of Hong Kong, Department of Clinical Oncology — Hong Kong, Hong Kong (RECRUITING)
• Rajiv Ghandhi Cancer Institute and Research Centre — New Delhi, India (RECRUITING)
• Pantai Hospital, Kuala Lumpur — Kuala Lumpur, Malaysia (RECRUITING)
• University Malaya Medical Centre, Clinical Oncology Department — Kuala Lumpur, Malaysia (RECRUITING)
• Penang Adventist Hospital — Penang, Malaysia (RECRUITING)
• Beacon Hospital — Petaling Jaya, Malaysia (RECRUITING)
• National Cancer Centre Singapore — Singapore, Singapore (RECRUITING)
• Phramongkutklao Hospital — Bangkok, Thailand (RECRUITING)

Study contacts

• Principal investigator: Daniel Tan, BSc, MBBS, MRCP — National Cancer Centre, Singapore
• Study coordinator: Justine Chu

Conditions: Lung Cancer, Non-Small Cell Lung Cancer, Oncomine Focus Panel Assay, Molecular profiling, Targeted therapies, Driver oncogene, Next-Generation Sequencing, PD-L1 Immunohistochemistry