Enrolling by invitationNCT04708639MonAlecUpdated Feb 2, 2021

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

An observational study in Lung Cancer, ALK Gene Mutation and Resistance, Disease, sponsored by Aarhus University Hospital. Enrolling by invitation at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-02.

Sponsored by Aarhus University Hospital · Observational

From the registry’s dates

Primary completion was expected by Jun 2022, 4 years 3 months ago, but the record still lists the study as enrolling by invitation.

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 40
Ages: 18 Years and older
Sex: All

Study summary

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

Read the 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 studied

Lung Cancer
ALK Gene Mutation
Resistance, Disease
Mutation

Browse trials for

Lung Neoplasms 7,243

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 40 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Aarhus University Hospital is the lead sponsor of 289 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

All newly diagnosed ALK translocated lung cancer adenocarcinomas.

Inclusion criteria

Patients with ALK translocated metastatic NSCLC, treated with alectinib as 1st line therapy in routine clinical practice
Written (personally dated and signed) informed consent

Exclusion criteria

Exclusion Criteria:

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 40 participants (estimated)
Patient registry: No
Biospecimen retention: Samples with dna

Interventions

DrugAlectinib
Use of ctDNA to establish response and resistance to alectinib.

What researchers measure

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

Study locations

1 site

Aarhus University Hospital
Aarhus, 8200, Denmark

References and documents

Individual participant data

Plan to share: Undecided — All data will be published

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04708639
Lead sponsor: Aarhus University Hospital
Collaborators: Roche Pharma AG
Responsible party: Peter Meldgaard (MD PhD, Aarhus University Hospital) — Principal investigator
First posted: Jan 14, 2021
Start date: Jun 19, 2019
Primary completion: Jun 30, 2022 (estimated)
Completion: Jun 30, 2025 (estimated)
Last update: Feb 2, 2021

Study contacts

Peter Meldgaard, MD, PhD

principal investigator · Aarhus University Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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Discussion

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