Text Size

Tyrosine Kinase Inhibitors In Metastatic Non Small Cell Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Istituto Clinico Humanitas.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT01163058
First received: June 29, 2010
Last updated: July 27, 2010
Last verified: July 2010
History of Changes
  Purpose

Aim of the present retrospective study is to evaluate molecular factors of primary resistance to tyrosine kinase inhibitors in metastatic non small cell lung cancer (NSCLC) patients. The investigators assess first, the incidence of epidermal growth factor receptor (EGFR) and Kirsten ras sarcoma viral oncogene homolog (KRAS) mutations, SOS and hepatocyte growth factor (HGF) expression, anaplastic lymphoma kinase (ALK) translocation and expression and, secondly, the investigators correlate molecular markers with clinical features and outcome in terms of response rate, progression free survival and overall survival.


Condition
Non Small Cell Lung Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Drug Information available for: Tyrosine
U.S. FDA Resources

Further study details as provided by Istituto Clinico Humanitas:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Investigate the association of clinical features such as sex, age, smoking history and histology with oncogenic alterations. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: June 2010
Estimated Study Completion Date: July 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Non small cell lung cancer patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

non small cell lung cancer patients treated with gefitinib or erlotinib

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01163058

Locations
Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20059
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
  More Information

No publications provided

Responsible Party: Armando Santoro, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT01163058     History of Changes
Other Study ID Numbers: ONC/OSS-01/2010
Study First Received: June 29, 2010
Last Updated: July 27, 2010
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013