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

Aarhus University Hospital40 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Lung Cancer ALK Gene Mutation Resistance, Disease Mutation

Interventions

AlectinibDRUG

Use of ctDNA to establish response and resistance to alectinib.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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:

Locations (1)

Aarhus University Hospital

Aarhus, Denmark

Outcomes

Primary Outcomes

PFS on alectinib

time from initiation of treatment to progression

Time frame: 46 month

mechanism of resistance

ctDNA to establish resistance mechanisms to alectinib treatment

Time frame: 15.2 month

Data from ClinicalTrials.gov

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