ALK Gene Mutation, Lung Cancer, Mutation, Resistance, Disease
Conditions
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.
Interventions
DRUGAlectinib
Use of ctDNA to establish response and resistance to alectinib.
Sponsors
Roche Pharma AG
Aarhus University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS on alectinib | 46 month | time from initiation of treatment to progression |
| mechanism of resistance | 15.2 month | ctDNA to establish resistance mechanisms to alectinib treatment |
Countries
Denmark
Outcome results
None listed