Plasma Molecular Profiling in ALK Inhibitor Resistant NSCLC

Recruiting

• Conditions: Non-small Cell Lung Cancer; ALK-Positive Lung Cancer

• Registration Number: NCT04087473
• Lead Sponsor: National Cancer Centre, Singapore

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-23
• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-10
• Study First Posted: 2019-09-12
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Molecular profiling of plasma	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 Outcome Measures

Name	Time	Method
Clinical outcomes of the subsequent treatments the patients receive	After molecular profiling has been completed, every few months up to 2 years
Patient survival status	After molecular profiling has been completed, every few months up to 2 years
Subsequent patient treatment status	After molecular profiling has been completed, every few months up to 2 years

Trial Locations

Locations (5)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Centre; 🇰🇷 Seoul, Korea, Republic of

National Cancer Center Singapore; 🇸🇬 Singapore, Singapore

University Malaya Medical Centre; 🇲🇾 Kuala Lumpur, Malaysia

The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong