Status:
COMPLETED
Study of Plasma NGS for Assessment, Characterization, Evaluation of Patients With ALK Resistance
Lead Sponsor:
Addario Lung Cancer Medical Institute
Collaborating Sponsors:
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief Summary
ALK-positive lung cancer is a subtype of lung cancer which carries a change in a gene called ALK (anaplastic lymphoma kinase). There are now many drugs for patients with ALK-positive lung cancer that ...
Detailed Description
SPACEWALK is an innovative remote consent and participation study using next-generation sequencing (NGS) of plasma cell-free DNA (cfDNA) to characterize resistance mechanisms arising in ALK-positive n...
Eligibility Criteria
Inclusion
- Men or women older than 18 years at the time of consent.
- Demonstration of having advanced ALK positive NSCLC.
- Systemic progression (not CNS only progression) within the past 30 days while receiving a next generation ALK TKI.
- Patient must not have started a new line of therapy before signing the informed consent form.
- Willingness to provide a blood specimen prior to the initiation of a new line of treatment.
- Willing to provide clinical and medical information to the study team as required.
- Ability to read, write and communicate in English.
- Ability to sign a web-based informed consent form.
Exclusion
- Participants who are unable to provide informed consent.
- Participants who are 18 years of age or younger.
- Participants who are unable to comply with the study procedures.
- Known existence of an uncontrolled intercurrent illness including, but not limited to, psychiatric illness or social situations that would impair compliance with study requirements.
- Participants who have previously enrolled to the study
Key Trial Info
Start Date :
January 23 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03833934
Start Date
January 23 2019
End Date
October 31 2023
Last Update
October 2 2025
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215