Status:
RECRUITING
Plasma Molecular Profiling in ALK Inhibitor Resistant NSCLC
Lead Sponsor:
National Cancer Centre, Singapore
Collaborating Sponsors:
Guardant Health AMEA, Inc.
Conditions:
Non-small Cell Lung Cancer
ALK-Positive Lung Cancer
Eligibility:
All Genders
21+ years
Brief 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. This study will pr...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 23 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04087473
Start Date
August 23 2019
End Date
December 31 2025
Last Update
June 12 2025
Active Locations (5)
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1
The Chinese University of Hong Kong
Hong Kong, Hong Kong
2
University Malaya Medical Centre
Kuala Lumpur, Malaysia
3
National Cancer Center Singapore
Singapore, Singapore, 169690
4
Asan Medical Centre
Seoul, South Korea, 05505