Tyrosine Kinase Inhibitors In Metastatic Non Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT01163058 |
Recruitment Status : Unknown
Verified July 2010 by Istituto Clinico Humanitas.
Recruitment status was: Active, not recruiting
First Posted : July 15, 2010
Last Update Posted : July 29, 2010
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Condition or disease |
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Non Small Cell Lung Cancer |
Study Type : | Observational |
Estimated Enrollment : | 300 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | Retrospective Analysis Evaluating Molecular Factors of Primary Resistance to Tyrosine Kinase Inhibitors in Metastatic Non Small Cell Lung Cancer Patients |
Study Start Date : | June 2010 |
Actual Primary Completion Date : | July 2010 |
Estimated Study Completion Date : | July 2011 |

- Determine the incidence of EGFR (Epidermal growth factor ) and KRAS (Kirsten ras sarcoma viral oncogene homolog ) mutations in 300 NSCLC (non small cell lung cancer) patients treated with gefitinib or erlotinib [ Time Frame: 1 year ]
- Investigate the association of clinical features such as sex, age, smoking history and histology with oncogenic alterations. [ Time Frame: 1 year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Histologically confirmed diagnosis of NSCLC (non small cell lung cancer) with available tumor tissue for mutational analysis
- Metastatic disease treated with gefitinib or erlotinib
- Presence of at least one measurable lesion according to RECIST criteria
Exclusion Criteria:
- No tumor tissue available
- No clinical data available

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163058
Italy | |
Istituto Clinico Humanitas | |
Rozzano, Milano, Italy, 20059 |
Principal Investigator: | Armando Santoro, MD | Istituto Clinico Humanitas |
Responsible Party: | Armando Santoro, MD, Istituto Clinico Humanitas |
ClinicalTrials.gov Identifier: | NCT01163058 History of Changes |
Other Study ID Numbers: |
ONC/OSS-01/2010 |
First Posted: | July 15, 2010 Key Record Dates |
Last Update Posted: | July 29, 2010 |
Last Verified: | July 2010 |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |