Non-small Cell Lung CancerNCT04087473
Plasma Molecular Profiling in ALK Inhibitor Resistant NSCLC
An observational study of Non-small Cell Lung Cancer and ALK-Positive Lung Cancer, run by National Cancer Centre, Singapore at 5 sites in 4 countries.
Trial summary
The investigators plan to understand a comprehensive molecular profiling via the plasma, with the primary aim of using this form on analysis to guide subsequent treatment selection. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, ALK-Positive Lung Cancer
- How many people
- 50 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 23 Aug 2019to 31 Dec 2025
- 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: Two cohorts will be enrolled, the first cohort will consist of patients that have received prior 2nd generation ALKi only, and the second cohort with patients that have received prior 1st and 2nd generation ALKi.
Who may be able to join
- Patients with advanced ALK fusion oncogene positive lung adenocarcinoma that have progressed after 1-2 ALK inhibitors, with at least one prior line of 2nd generation ALKi (i.e. Ceritinib, Alectinib, Brigatinib or Ensartinib)
- The availability of sufficient plasma
- Age ≥ 21 years
- WHO performance status ≤ 2
- Life expectancy of ≥ 21 weeks
- Patients should have adequate organ function for potential consideration into clinical trials (routine blood tests are valid within 14 days before enrollment):
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- Adequate bone marrow function as shown by: ANC ≥ 1.0x10^9/L, Platelets ≥ 75x10^9/L, Hb ≥ 7.5 g/dL
- Alanine aminotransferase (ALT) and aspirate aminotransferase (AST) normal range (or ≤ 3.0xULN 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 within the study team, for potential enrolment
Who cannot join
- Received more than 2 prior ALK inhibitors (ALKi)
- Symptomatic or uncontrolled brain metastases requiring concurrent treatment inclusive but not limited to surgery and radiation. Stable/ tailing doses of corticosteroids is permitted
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
South Korea2 sites
Asan Medical Centre
Seoul, 05505
Seoul National University Hospital
Seoul
About this study
Official title: Plasma Molecular Profiling in ALK Inhibitor Resistant Non-Small Cell Lung Cancer
The investigators plan to understand a comprehensive molecular profiling via the plasma, with the primary aim of using this form on analysis to guide subsequent treatment selection. This study will provide a better understanding of ALK resistance in the treatment of Asian lung cancers and allow for improved clinical outcomes by 'matching' the secondary mutations to an ALK inhibitor which would allow for the greatest coverage ultimately leading to lasting duration of response.
- Keywords
- ALK inhibitor (ALKi), NSCLC, Anaplastic lymphoma kinase (ALK) fusion oncogene NSCLC, Guardant360 assay, Next-Generation Sequencing (NGS) DNA sequencing test, Cell-free circulating tumor DNA (ctDNA), Plasma profiling, Blood-based assay, Mutational testing, 74 genetic alterations (point mutations, copy number variants, fusions, insertions, deletions), ALK resistance mutations
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prior 2nd generation ALKi | Not described | |
| Prior 1st and 2nd generation ALKi | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular profiling of plasma
Profiling of the collected plasma samples at a molecular level to evaluate the molecular epidemiology of ALK fusion oncogene positive lung cancer
Measured: 2 to 4 weeks after collection of plasma
Secondary outcomes (3)
Patient survival status
Measured: After molecular profiling has been completed, every few months up to 2 years
Subsequent patient treatment status
Measured: After molecular profiling has been completed, every few months up to 2 years
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 posted12 Sep 2019
- Study start23 Aug 2019
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Guardant Health AMEA, Inc.
- Responsible party
- Sponsor
- Investigators
- Daniel SW Tan, BSc, MBBS, PhD, Principal investigator, National Cancer Centre of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087473
- Sponsor's protocol ID
- ATORG004
- Status last verified
- May 2026
- First submitted
- 9 Sep 2019
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Molecular Profiling in ALK Inhibitor Resistant Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04087473
- Acronym / sponsor ID
- ATORG004
- Keywords
- ALK inhibitor (ALKi), NSCLC, Anaplastic lymphoma kinase (ALK) fusion oncogene NSCLC, Guardant360 assay, Next-Generation Sequencing (NGS) DNA sequencing test, Cell-free circulating tumor DNA (ctDNA), Plasma profiling, Blood-based assay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Collaborators
- Guardant Health AMEA, Inc.
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 12 Sep 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.
The investigators plan to understand a comprehensive molecular profiling via the plasma, with the primary aim of using this form on analysis to guide subsequent treatment selection. This study will provide a better understanding of ALK resistance in the treatment of Asian lung cancers and allow for improved clinical outcomes by 'matching' the secondary mutations to an ALK inhibitor which would allow for the greatest coverage ultimately leading to lasting duration of response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prior 2nd generation ALKi | – | – |
| Prior 1st and 2nd generation ALKi | – | – |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Two cohorts will be enrolled, the first cohort will consist of patients that have received prior 2nd generation ALKi only, and the second cohort with patients that have received prior 1st and 2nd generation ALKi.
Key inclusion criteria (10 listed)
- Patients with advanced ALK fusion oncogene positive lung adenocarcinoma that have progressed after 1-2 ALK inhibitors, with at least one prior line of 2nd generation ALKi (i.e. Ceritinib, Alectinib, Brigatinib or Ensartinib)
- The availability of sufficient plasma
- Age ≥ 21 years
- WHO performance status ≤ 2
- Life expectancy of ≥ 21 weeks
Key exclusion criteria (2 listed)
- Received more than 2 prior ALK inhibitors (ALKi)
- Symptomatic or uncontrolled brain metastases requiring concurrent treatment inclusive but not limited to surgery and radiation. Stable/ tailing doses of corticosteroids is permitted
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 plasma
Time frame: 2 to 4 weeks after collection of plasma
Profiling of the collected plasma samples at a molecular level to evaluate the molecular epidemiology of ALK fusion oncogene positive lung cancer
3 secondary outcomes
Patient survival status
Time frame: After molecular profiling has been completed, every few months up to 2 years
Subsequent patient treatment status
Time frame: After molecular profiling has been completed, every few months up to 2 years
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- 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 SW Tan, BSc, MBBS, PhD principal investigator
National Cancer Centre of Singapore
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer and ALK-Positive Lung Cancer, run by National Cancer Centre, Singapore at 5 sites in 4 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 10 inclusion and 2 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: finished, as of the sponsor's last update on 13 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 5 sites in South Korea, Hong Kong, Malaysia, Singapore. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 plasma (time frame: 2 to 4 weeks after collection of plasma). 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 13 May 2026.