Blood-based Identification and Monitoring of Patients With ALK-translocated Lung Cancer

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

Identification of Response to ALK-targeted Treatment in Lung Cancer Patients by Monitoring Tumor DNA in Blood Samples

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02718651
• Other study ID #: 2015-1881-2
• Secondary ID: 1-10-72-266-151-
• Status: Completed
• Start date: March 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Genetic rearrangements in the Anaplastic Lymphoma Kinase (ALK) gene result in the creation of a variety of oncogenic fusion proteins that drive malignancy in a subset of non-small cell lung cancers (NSCLC) patients. Treatment with the ALK small tyrosine kinase inhibitor (TKI) crizotinib has produced remarkable results for ALK-positive patients, however the current diagnostic tests used in the clinic are not sufficiently detailed and require a tumor biopsy.

The aim of this study is to use a new diagnostic test to detect ALK rearrangements using next generation sequencing, which will improve the diagnosis and treatment of ALK-positive NSCLC patients. Furthermore, this test will be performed on blood samples, making it minimally invasive for the patients. It is our believe that circulating tumor DNA (ctDNA) in blood can be employed as an easy accessible and comprehensive source of information to diagnose ALK-positive disease, but also as a means of monitoring patient response during treatment. Quantitation of the the amount of ALK rearrangement will give information about which patients benefit from treatment and when treatment is no longer effective. The project will be a multicenter study where blood samples will be collected every 6 weeks from patients treated at four major hospitals in Denmark.

This study will benefit future patients with lung cancer, as it will improve both the monitoring and evaluation of their treatment. Monitoring patients during treatment will provide more knowledge of disease progression and the effect of ALK-TKI treatment, contributing to a greater selection of patients, who will respond to treatment. This will potentially allow effective treatment to continue longer than with conventional methods

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Non-small cell lung cancer diagnosis

• Biopsy-verified ALK-translocation

Exclusion Criteria:

• Patients were it is not possible to retrieve a biopsy

• Patients with squamous cell carcinoma

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Aalborg University Hospital, Aarhus University Hospital, Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		2 years