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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective

Primary Outcomes

Association of each biomarker with treatment outcome in terms of response rate, time to progression, overall survival.
time frame: one year

Secondary Outcomes

Association of each biomarker with clinico-pathological features: histology, gender, age, smoking status, response to previous chemotherapy.
time frame: one year

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2010.
Information provided to ClinicalTrials.gov by Istituto Clinico Humanitas.