NCT04708639Enrolling By InvitationNot Applicable
Monitoring Alectinib Treatment by Detection of ALK Translocations in Serial Blood Samples From Non-Small Cell Lung Cancer Patients
Aarhus University Hospital1 site in 1 country40 target enrollmentStarted: June 19, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- mechanism of resistance
Study Overview
Brief Summary
Circulating tumor DNA can be used to monitor the treatment effect and identify developing resistance mutations during ALK directed TKI treatment.
Detailed Description
The purpose and objectives of the non-interventional study with primary data collection is
- To determine if monitoring the amount of translocated DNA in the blood reflects alectinib treatment effect.
- To assess the presence and type of resistance mutations using ctDNA at the time patients experience clinical progression on alectinib.
- To investigate if the resistance mutations identified at clinical progression could have been identified in blood samples taken before clinically evident progression.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with ALK translocated metastatic NSCLC, treated with alectinib as 1st line therapy in routine clinical practice
- •Written (personally dated and signed) informed consent
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
mechanism of resistance
Time Frame: 15.2 month
ctDNA to establish resistance mechanisms to alectinib treatment
PFS on alectinib
Time Frame: 46 month
time from initiation of treatment to progression
Secondary Outcomes
No secondary outcomes reported
Investigators
Peter Meldgaard
MD PhD
Aarhus University Hospital
Study Sites (1)
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