NCT04087473Completed
Plasma Molecular Profiling in ALK Inhibitor Resistant NSCLC
Plasma Molecular Profiling in ALK Inhibitor Resistant Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 50 (actual)
- First submitted
- 9 Sept 2019
- Start date
- 23 Aug 2019
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- National Cancer Centre, Singapore
- Diseases
- Lung cancer
- NCT number
- NCT04087473
What you commit to
- Study type: Observational
- Participants enrolled: 50
- From 23 Aug 2019 to the primary completion date, 31 Dec 2025
- 5 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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):
- 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
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Chinese University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Asan Medical Centre Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| University Malaya Medical Centre Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| National Cancer Center Singapore Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.