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Plasma Molecular Profiling in ALK Inhibitor Resistant NSCLC | Clinical Trials | Clareo Health

RECRUITING

Plasma Molecular Profiling in ALK Inhibitor Resistant NSCLC

Plasma Molecular Profiling in ALK Inhibitor Resistant Non-Small Cell Lung Cancer

NCT04087473•National Cancer Centre, Singapore

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 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.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (5)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

University Malaya Medical Centre

Kuala Lumpur, Malaysia

National Cancer Center Singapore

Singapore, Singapore

Asan Medical Centre

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Key Dates

Start Date

August 23, 2019

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2025

Last Updated

June 12, 2025

Enrollment

ESTIMATED participants

Conditions

Non-small Cell Lung CancerALK-Positive Lung Cancer

Contacts

Cherlyn Shepherdson

CONTACT

+65 63061748 cherlyn.shepherdson@nccs.com.sg

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Plasma Molecular Profiling in ALK Inhibitor Resistant NSCLC

Inclusion Criteria

Exclusion Criteria

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