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Plasma Molecular Profiling in ALK Inhibitor Resistant NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04087473
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Guardant Health AMEA, Inc.
Information provided by (Responsible Party):
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.

Condition or disease
Non-small Cell Lung Cancer ALK-Positive Lung Cancer

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Plasma Molecular Profiling in ALK Inhibitor Resistant Non-Small Cell Lung Cancer
Actual Study Start Date : August 23, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Prior 2nd generation ALKi
Prior 1st and 2nd generation ALKi

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
15-20mL of plasma

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Two cohorts will be enrolled, the first cohort will consist of patients that have received prior 2nd generation ALKi only, and the second cohort with patients that have received prior 1st and 2nd generation ALKi.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04087473

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Contact: Esther Koh +65 6236 9460

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Hong Kong
The Chinese University of Hong Kong Not yet recruiting
Hong Kong, Hong Kong
Korea, Republic of
Asan Medical Centre Not yet recruiting
Seoul, Korea, Republic of, 05505
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of
University Malaya Medical Centre Not yet recruiting
Kuala Lumpur, Malaysia
National Cancer Center Singapore Recruiting
Singapore, Singapore, 169690
Sponsors and Collaborators
National Cancer Centre, Singapore
Guardant Health AMEA, Inc.
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Principal Investigator: Daniel SW Tan, BS,cMBBS, PhD National Cancer Centre of Singapore

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Responsible Party: National Cancer Centre, Singapore Identifier: NCT04087473     History of Changes
Other Study ID Numbers: ATORG004
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Cancer Centre, Singapore:
ALK inhibitor (ALKi)
Anaplastic lymphoma kinase (ALK) fusion oncogene NSCLC
Guardant360 assay
Next-Generation Sequencing (NGS) DNA sequencing test
Cell-free circulating tumor DNA (ctDNA)
Plasma profiling
Blood-based assay
Mutational testing
74 genetic alterations (point mutations, copy number variants, fusions, insertions, deletions)
ALK resistance mutations
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms