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Completed

NCT Number: NCT04087473

Plasma Molecular Profiling in ALK Inhibitor Resistant NSCLC

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.

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Key information

Conditions

Non-small Cell Lung Cancer ALK-Positive Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Chinese University of Hong Kong, Hong Kong

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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):
  • 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 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

Treatment and study plan

Primary outcomes

  1. Molecular profiling of plasma

    Time frame: 2 to 4 weeks after collection of plasma

    Profiling of the collected plasma samples at a molecular level to evaluate the molecular epidemiology of ALK fusion oncogene positive lung cancer

Secondary outcomes

  1. Patient survival status

    Time frame: After molecular profiling has been completed, every few months up to 2 years

  2. Subsequent patient treatment status

    Time frame: After molecular profiling has been completed, every few months up to 2 years

  3. Clinical outcomes of the subsequent treatments the patients receive

    Time frame: After molecular profiling has been completed, every few months up to 2 years

Sponsors and collaborators

Lead sponsor

National Cancer Centre, Singapore

Other

Collaborators

  • Guardant Health AMEA, Inc.

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Sep 12, 2019
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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