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

• Conditions: Mutation; Lung Cancer; ALK Gene Mutation; Resistance, Disease

• Registration Number: NCT04708639
• Lead Sponsor: Aarhus University Hospital

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 Timeline

• Study Start: 2019-06-19
• Status Verified: 2021-01
• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-14
• Last Update Submitted: 2021-01-30
• Last Update Posted: 2021-02-02
• Primary Completion: 2022-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mechanism of resistance	15.2 month	ctDNA to establish resistance mechanisms to alectinib treatment
PFS on alectinib	46 month	time from initiation of treatment to progression

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark