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OpenTrials
Completed

NCT Number: NCT01193959

Pemetrexed in Advanced Non-small Cell Lung Cancer

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).

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Key information

Conditions

Non-small Cell Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Association of each biomarker with treatment outcome in terms of response rate, time to progression, overall survival.

    Time frame: one year

Secondary outcomes

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

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Armando Santoro, MD

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Sep 2, 2010
Registry last updated
Sep 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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