Clinical trial · Observational
Plasma Molecular Profiling in ALK Inhibitor Resistant NSCLC
Plasma Molecular Profiling in ALK Inhibitor Resistant Non-Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ALK-Positive Lung Cancer | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Prior 2nd generation ALKi
- label
- Prior 1st and 2nd generation ALKi
Primary outcomes (1)
- measure
- Molecular profiling of plasma
- timeFrame
- 2 to 4 weeks after collection of plasma
- description
- Profiling of the collected plasma samples at a molecular level to evaluate the molecular epidemiology of ALK fusion oncogene positive lung cancer
Secondary outcomes (3)
- measure
- Patient survival status
- timeFrame
- After molecular profiling has been completed, every few months up to 2 years
- measure
- Subsequent patient treatment status
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * 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): 1. Adequate bone marrow function as shown by: ANC ≥ 1.0x10\^9/L, Platelets ≥ 75x10\^9/L, Hb ≥ 7.5 g/dL 2. 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available