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

NCT ID: NCT04708639

Last Updated: 2021-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-19

Study Completion Date

2025-06-30

Brief Summary

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

Detailed Description

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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

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Lung Cancer ALK Gene Mutation Resistance, Disease Mutation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Alectinib

Use of ctDNA to establish response and resistance to alectinib.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roche Pharma AG

INDUSTRY

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Peter Meldgaard

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Meldgaard, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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ML40920

Identifier Type: -

Identifier Source: org_study_id

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