Lung CancerNCT04025515
Molecular Profiling Project
An observational study of Lung Cancer and Non-Small Cell Lung Cancer, run by National Cancer Centre, Singapore at 10 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Lung Cancer, Non-Small Cell Lung Cancer
- How many people
- 500 participants
- Where
- 10 sitesin 6 countries
- Study dates
- 11 Jan 2019to 25 Dec 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Asian patients with Non-Small Cell Lung Cancer (NSCLC)
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- No more than 3 lines of cytotoxic chemotherapy at the time of enrolment
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
Malaysia4 sites
Penang Adventist Hospital
George Town
Pantai Hospital, Kuala Lumpur
Kuala Lumpur
University Malaya Medical Centre, Clinical Oncology Department
Kuala Lumpur
Beacon Hospital
Petaling Jaya
Hong Kong2 sites
Hong Kong Integrated Oncology Centre
Hong Kong
The Chinese University of Hong Kong, Department of Clinical Oncology
Hong Kong
Brunei1 site
The Brunei Cancer Centre
Brunei
About this study
Official title: ATORG001 - Molecular Profiling Project
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.
Read the 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.
- 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
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After patient meets the eligibility criteria and consent has been taken
Secondary outcomes (3)
Collection of patient survival status
Measured: After molecular profiling has been completed, every few months up to 2 years
Collection of subsequent patient treatment status
Measured: 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
Measured: After molecular profiling has been completed, every few months up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start11 Jan 2019
- Primary completion25 Dec 2026 (estimated)
- Study completion25 Dec 2026 (estimated)
Why it stopped: Discussion under way on how to continue/restart the study in view of slow recruitment rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore General Hospital
- Responsible party
- Sponsor
- Investigators
- Daniel Tan, BSc, MBBS, MRCP, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025515
- Sponsor's protocol ID
- ATORG001
- Status last verified
- May 2026
- First submitted
- 15 Jun 2019
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ATORG001 - Molecular Profiling Project
- ClinicalTrials.gov ID
- NCT04025515
- Acronym / sponsor ID
- ATORG001
- 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)
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Discussion under way on how to continue/restart the study in view of slow recruitment rate.
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Collaborators
- Singapore General Hospital
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asian patients with Non-Small Cell Lung Cancer (NSCLC)
Key inclusion criteria (9 listed)
- 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):
Key exclusion criteria (1 listed)
- No more than 3 lines of cytotoxic chemotherapy at the time of enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Molecular profiling of lung cancer specimens
Time frame: 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
3 secondary outcomes
Collection of patient survival status
Time frame: After molecular profiling has been completed, every few months up to 2 years
Collection of subsequent patient treatment status
Time frame: 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
Time frame: After molecular profiling has been completed, every few months up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Tan, BSc, MBBS, MRCP principal investigator
National Cancer Centre, Singapore
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Non-Small Cell Lung Cancer, run by National Cancer Centre, Singapore at 10 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Malaysia, Hong Kong, Brunei, India, Singapore and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular profiling of lung cancer specimens (time frame: After patient meets the eligibility criteria and consent has been taken). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.