Understanding plasma molecular profiling in lung cancer resistant to ALK inhibitors
Plasma Molecular Profiling in ALK Inhibitor Resistant Non-Small Cell Lung Cancer
This study is trying to see if analyzing blood samples from patients with advanced lung cancer who didn't respond to ALK inhibitors can help find better treatment options for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | National Cancer Centre, Singapore Academic / other |
| Drugs / interventions | Ceritinib, Alectinib, Brigatinib, Ensartinib, radiation |
| Locations | 5 sites (Hong Kong and 4 other locations) |
| Trial ID | NCT04087473 on ClinicalTrials.gov |
What this trial studies
This observational study aims to conduct comprehensive molecular profiling of plasma samples from patients with advanced ALK-positive non-small cell lung cancer (NSCLC) who have progressed after treatment with 1-2 ALK inhibitors. The goal is to analyze secondary mutations that contribute to ALK resistance, thereby guiding subsequent treatment selection. By utilizing advanced techniques such as the Guardant360 assay and next-generation sequencing, the study seeks to improve clinical outcomes for patients by matching them with the most effective ALK inhibitors based on their unique molecular profiles.
Who should consider this trial
Good fit: Ideal candidates include patients aged 21 and older with advanced ALK fusion oncogene positive lung adenocarcinoma who have progressed after 1-2 ALK inhibitors.
Not a fit: Patients who have received more than 2 prior ALK inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients with ALK-positive NSCLC.
How similar studies have performed: Other studies utilizing molecular profiling and next-generation sequencing have shown promise in improving treatment outcomes for similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hong Kong and 4 other locations
- The Chinese University of Hong Kong — Hong Kong, Hong Kong (Not_yet_recruiting)
- Asan Medical Centre — Seoul, Korea, Republic of (Not_yet_recruiting)
- Seoul National University Hospital — Seoul, Korea, Republic of (Not_yet_recruiting)
- University Malaya Medical Centre — Kuala Lumpur, Malaysia (Not_yet_recruiting)
- National Cancer Center Singapore — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Daniel SW Tan, BSc, MBBS, PhD — National Cancer Centre of Singapore
- Study coordinator: Justine Chu
- Email: justine.chu.j.h@nccs.com.sg
- Phone: +65 64368000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.