NCT04708639

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer
• ALK Gene Mutation
• Resistance, Disease
• Mutation

Interventions

Type	Name	Description
DRUG	Alectinib	Use of ctDNA to establish response and resistance to alectinib.

Timeline

• Start date: 2019-06-19
• Primary completion: 2022-06-30
• Completion: 2025-06-30
• First posted: 2021-01-14
• Last updated: 2021-02-02

Locations

1 site across 1 country: Denmark

Regulatory

• FDA-regulated drug study