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

Status: Recruiting
Location: See all (5) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Hong Kong Special Administrative Region
The Chinese University of Hong Kong
NOT_YET_RECRUITING
Hong Kong
Malaysia
University Malaya Medical Centre
RECRUITING
Kuala Lumpur
Republic of Korea
Asan Medical Centre
NOT_YET_RECRUITING
Seoul
Seoul National University Hospital
NOT_YET_RECRUITING
Seoul
Singapore
National Cancer Center Singapore
RECRUITING
Singapore
Contact Information
Primary
Cherlyn Shepherdson
cherlyn.shepherdson@nccs.com.sg
+65 63061748
Time Frame
Start Date: 2019-08-23
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 50
Treatments
Prior 2nd generation ALKi
Prior 1st and 2nd generation ALKi
Authors
Daniel SW Tan
Sponsors
Collaborators: Guardant Health AMEA, Inc.
Leads: National Cancer Centre, Singapore

This content was sourced from clinicaltrials.gov