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Pemetrexed in Advanced Non-small Cell Lung Cancer

Retrospective Study of Molecular Predictors of Sensitivity and Resistance to Pemetrexed in Advanced Non-Small Cell Lung Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01193959
Enrollment
33
Registered
2010-09-02
Start date
2010-09-30
Completion date
2012-06-30
Last updated
2022-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer (NSCLC)

Brief summary

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).

Interventions

None listed

Sponsors

Armando Santoro, MD
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026