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

Aarhus University Hospital

Status: Invitation-only

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

Treatments: Drug: Alectinib

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04708639

ML40920

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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: