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NCT04708639 Clinical Trial

Monitoring Alectinib Treatment by Detection of ALK Translocations in Serial Blood Samples From Non-Small Cell Lung Cancer Patients

Lung Cancer Clinical Trial

— MonAlec  

Official title:
Monitoring Alectinib Treatment by Detection of ALK Translocations in Serial Blood Samples From Non-Small Cell Lung Cancer Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04708639
Other study ID # ML40920
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 19, 2019
Est. completion date June 30, 2025

Study information
Verified date January 2021
Source Aarhus University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Circulating tumor DNA can be used to monitor the treatment effect and identify developing resistance mutations during ALK directed TKI treatment.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 40
Est. completion date June 30, 2025
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients with ALK translocated metastatic NSCLC, treated with alectinib as 1st line therapy in routine clinical practice 2. Written (personally dated and signed) informed consent Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Alectinib
Use of ctDNA to establish response and resistance to alectinib.

Locations
Country Name City State
Denmark Aarhus University Hospital Aarhus

Sponsors (2)
Lead Sponsor Collaborator
Aarhus University Hospital Roche Pharma AG

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary PFS on alectinib time from initiation of treatment to progression 46 month
Primary mechanism of resistance ctDNA to establish resistance mechanisms to alectinib treatment 15.2 month
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