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Survey on the Treatment Reality of Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive Non-small Cell Lung Cancer(NSCLC)

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ClinicalTrials.gov Identifier: NCT02475720
Recruitment Status : Completed
First Posted : June 19, 2015
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
According to the recent report using EGFR tyrosine kinase inhibitors (EGFR-TKI), there is all over survival of the EGFR gene mutation-positive NSCLC in a tendency to extension. However, the real situation and the reason are not clarified.This observational study collects the data of EGFR gene mutation-positive NSCLC approximately 2,000 from the medical record of approximately 20 facilities in Japan and observes the treatment reality of EGFR gene mutation-positive NSCLC.

Condition or disease
Carcinoma, Non-Small-Cell Lung

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Survey on the Treatment Reality of Patients With EGFR Mutation-positive Non-small Cell Lung Cancer
Actual Study Start Date : June 19, 2015
Actual Primary Completion Date : March 16, 2016
Actual Study Completion Date : March 16, 2016

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Primary Outcome Measures :
  1. Overall survival of the patients. [ Time Frame: Up to 3 monthes. Data will be collected retrospectively from medical records.Survival status as of the end of December 2014, date of death or date of last follow-up of survival. ]

Secondary Outcome Measures :
  1. Overall survival by patient background [ Time Frame: Up to 3 monthes. Data will be collected retrospectively from medical records. ]
  2. Overall survival by treatment sequence [ Time Frame: Up to 3 monthes. Data will be collected retrospectively from medical records. ]
  3. Treatment time by treatment category [ Time Frame: Up to 3 monthes. Data will be collected retrospectively from medical records. ]
  4. Time to Treatment Failure (TTF) of Gefitinib treatment [ Time Frame: Up to 3 monthes. Data will be collected retrospectively from medical records. ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Approximately 2000, Advanced Non Small Cell Lung cancer (aNSCLC) patients who fulfil the inclusion/exclusion criteria will be recruited by 10 to 20 investigational sites in Japan.
Criteria

Inclusion Criteria:

  • 1. EGFR mutation-positive progress recurrent non-small cell lung cancer subject.
  • 2. Subjects who commenced on first-line treatment between January, 2008 and December 2012.

Exclusion Criteria:

  • 1. Patients has a treatment history with the drug which was not approved for marketing authorization as of 31th December , 2014
  • 2. Person who were planning and/or getting involved in this survey. (applies to both AstraZeneca staff and/or staff at the study site)
  • 3. Previous enrolment in the present study.
  • 4. Patient was not evaluated to be appropriate for study enrolment by the investigators

Information from the National Library of Medicine

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): NCT02475720


Locations
Japan
Izumi Municipal Hospital
Izumi, Osaka, Japan, 594-0071
Sponsors and Collaborators
AstraZeneca

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02475720     History of Changes
Other Study ID Numbers: D7913R00015
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017

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