Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
Exploratory Phase 0/1 of Positron Emission Tomography (PET) Imaging Agent [18F]-ODS2004436 as a Marker of EGFR Mutation in Subjects With NSCLC
The development of biomarkers will lead the dynamic of personalized medicine and fill the
unsatisfied needs in oncology for prediction of therapeutic response.
Molecular imaging enables non invasive quantification of biomarkers. The development of
molecular imaging biomarkers is closely related to the development of therapeutic molecules.
Among the potential targets, kinases offer a lot of advantages: (i) they play a central role
in cellular regulation, (ii) numerous kinase-specific small molecule libraries exist in
biotech and pharma industry, (iii) several kinase-targeted therapies are used in clinic
(imatinib, sorafenib, sunitinib…) with application across a variety of therapeutic
indications. Among the imaging technologies, the Positron Emission Tomography (PET) is the
most sensitive and dedicated to evaluate small molecules. However few radiotracers are
available and their specificity limits their clinical use. The IMAkinib® approach is an
innovative method proposed to develop new PET radiotracers adapted to current medical and
economical challenges.
The epidermal growth factor receptor (EGFR) is an established target for the treatment of
advanced non-small cell lung cancer (NSCLC). The EGFR tyrosine kinase inhibitors (TKIs)
Gefitinib (Iressa®), erlotinib (Tarceva®) and afatinib (Giotrif®) have already been approved
for treatment of NSCLC harboring EGFR activating mutations (L858R or del exon 19).
Unfortunately the majority of patients will develop a resistance to the TKI in the long term
(6-12 months). If the mechanism of resistance is not yet fully characterized, most patients
(50%) will acquire an additional T790M mutation of EGFR. TKI PET-imaging can provide a tool
to determine and predict responsiveness to EGFR TKI in vivo. That is why, the investigators
have selected and radiolabeled (18-Fluor) a compound targeting specifically EGFR mutated
([18F]-ODS2004436) which was further evaluated in a preclinical imaging study to determine
the feasibility of TKI-PET. The investigators proved in vivo that [18F]-ODS2004436 a compound
is a good candidate to evaluate the EGFR activity in human lung tumours using PET imaging.
n/a
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