Pemetrexed in Advanced Non-small Cell Lung Cancer
This trial is active, not recruiting.
|Condition||non-small cell lung cancer (nsclc)|
|Sponsor||Istituto Clinico Humanitas|
|Start date||September 2010|
|End date||September 2010|
|Trial size||33 participants|
|Trial identifier||NCT01193959, ONC/OSS-02/2010|
Present study is aimed at investigating potential molecular predictors of sensitivity or resistance to single-agent pemetrexed in the ≥ second line setting in a large cohort of advanced non-small cell lung cancer (NSCLC) patients. The following biomarkers will be investigated with either immunohistochemistry, fluorescence in situ hybridization or genotyping: thymidylate synthase (TS), dihydrofolate reductase (DHFR), glycinamide ribonucleotide formyl transferase (GARFT), aminoimidazole carboxamide ribonucleotide formyltransferase (ATIC/AICARFT), epidermal growth factor receptor (EGFR), Kirsten rat sarcoma 2 viral oncogene homolog (KRAS), v-myc myelocytomatosis viral oncogene homolog (MYC) and phosphoinositide-3-kinase, catalytic, alpha polypeptide (PIK3CA).
Association of each biomarker with treatment outcome in terms of response rate, time to progression, overall survival.
time frame: one year
Association of each biomarker with clinico-pathological features: histology, gender, age, smoking status, response to previous chemotherapy.
time frame: one year
Male or female participants at least 18 years old.
Inclusion Criteria: - Histologically confirmed diagnosis of advanced non-small cell lung cancer - Tumor tissue available at our institution - Patients treated with single agent pemetrexed for metastatic disease - Availability of full clinical data Exclusion Criteria: - Cytological diagnosis of advanced Non-small cell lung cancer - Lack of tumor tissue at our institution - Lack of full clinical data
|Official title||Retrospective Study of Molecular Predictors of Sensitivity and Resistance to Pemetrexed in Advanced Non-Small Cell Lung Cancer|
|Principal investigator||Armando SANTORO, MD|
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