De Novo Resistance to Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors (NCT01697163) | Clinical Trial Compass
UnknownNot Applicable
De Novo Resistance to Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors
155 participantsStarted 2012-10
Plain-language summary
This study is based on the following hypothesis "De novo resistance to EGFR-TKI in EGFR mutation positive patients is related with mutations in EGFR downstream genes".
Investigators will prospectively collect genomic DNA and clinical data regarding treatment outcomes to EGFR-TKI in NSCLC patients with activating EGFR mutations. Investigators will sequence candidate mutations of EGFR downstream genes and analyze c-met gene amplification and protein expression in PTEN, HGF, and IGFR. To identify genetic mutations, amplification, and protein over expression as predictive markers of treatment outcomes, investigators analyzed the association of treatment outcomes with the presence of genetic alteration or protein over expression. Investigators will attempt to identify biomarkers that are able to predict de novo resistance to EGFR-TKI in EGFR mutated NSCLC.
Who can participate
Age range20 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Pathologically proven unresectable NSCLC
✓. 20 years of age or older
✓. Planned treatment with Iressa®
✓. Patients with activating EGFR mutation (del 19, L858R)
✓. Available detailed smoking history
✓. Available tissue samples (archival tissue) for mutational or molecular analysis (representative paraffin block or unstained sections from tumor diagnostic specimen are mandatory)
✓. Available blood sample
✓. At least one lesion that is measurable according to the RECIST 1.1 criteria by CT or MRI