Plasma Molecular Profiling in ALK Inhibitor Resistant NSCLC

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04087473
• Other study ID #: ATORG004
• Status: Recruiting
• Start date: August 23, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: National Cancer Centre, Singapore
• Contact: Justine Chu
• Phone: +65 64368000
• Email: justine.chu.j.h[@]nccs.com.sg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ALK-Positive Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong
Korea, Republic of	Asan Medical Centre	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Singapore	National Cancer Center Singapore	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Centre, Singapore	Guardant Health AMEA, Inc.

Countries where clinical trial is conducted

Hong Kong,  Korea, Republic of,  Malaysia,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Molecular profiling of plasma	Profiling of the collected plasma samples at a molecular level to evaluate the molecular epidemiology of ALK fusion oncogene positive lung cancer	2 to 4 weeks after collection of plasma
Secondary	Patient survival status		After molecular profiling has been completed, every few months up to 2 years
Secondary	Subsequent patient treatment status		After molecular profiling has been completed, every few months up to 2 years
Secondary	Clinical outcomes of the subsequent treatments the patients receive		After molecular profiling has been completed, every few months up to 2 years