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Clinical Trials/NCT04708639
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

Sponsor
Aarhus University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Peter Meldgaard

MD PhD

Aarhus University Hospital

Study Sites (1)

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