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
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
n/a
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