Ca_Pulmon: Retrospective Study in a NSCLC M+ p

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01795352
• Collaborator: (none)
• Enrollment: 187
• Locations: 12
• Duration (Months): 7
• Patients Per Site: 15.6
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

This is a national, multicentre, non-interventional, retrospective study to be carried out in the oncology settings of approximately 15-20 Spanish hospitals.

At each participant hospital, all patients recently diagnosed with advanced EGFR mutated NSCLC (both newly or with recurrent disease , without previous treatment for metastatic disease) from April 2010 to December 2011 will be included as study population. Information about the follow-up of the patients during a minimum of 12 months after diagnosis will be collected.

Condition or Disease	Intervention/Treatment	Phase
EGFR Mutated Non-small Cell Lung Cancer Patients

Detailed Description

Observational retrospective study to describe the management of advanced or metastatic EGFR mutated non-small cell lung cancer patients in Spain

Study Design

• Study Type: Observational
• Actual Enrollment: 187 participants
• Time Perspective: Retrospective
• Official Title: Observational Retrospective Study to Describe the Management of Advanced or Metastatic EGFR (Epidermal Growth Factor Receptor) Mutated Non-small Cell Lung Cancer Patients in Spain
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Outcome Measures

Primary Outcome Measures

1. Description of management patterns (clinical and diagnostic) of advanced/metastatic EGFR M+ NSCLC patients in Spain. [32 months]

Secondary Outcome Measures

1. Description of use of resources related with the management of advanced/metastatic EGFR M+ NSCLC patients in Spain. [32 months]

2. Evaluation of overall response rate (ORR). [32 months]

3. Evaluation of disease control rate (DCR). [32 months]

4. Evaluation of progression free survival (PFS: median PFS and 1 year PFS rate). [32 months]

5. Evaluation of overall survival (OS: median OS and 1 year OS rate). [32 months]

6. Description of clinical outcome data in all EGFR M+ patients by regimen, type of EGFR TK mutation, line of therapy and other relevant demographics or clinic pathologic characteristics. [32 months]

   TK- Tyrosine Kinase

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologically or cytologically confirmed newly locally advanced or metastatic NSCLC (stage IIIB/IV)

• Confirmed EGFR mutation by a validated test

• Availability of medical record

Exclusion Criteria:

• Participating on a blinded randomized clinical trial at any time during the study period

• Pregnant women (due to they do not reflect daily clinical practice)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Barcelona		Spain
2	Research Site	Cordoba		Spain
3	Research Site	Donostia		Spain
4	Research Site	Granada		Spain
5	Research Site	Leon		Spain
6	Research Site	Madrid		Spain
7	Research Site	Malaga		Spain
8	Research Site	Navarra		Spain
9	Research Site	Sevilla		Spain
10	Research Site	Toledo		Spain
11	Research Site	Valencia		Spain
12	Research Site	Zaragoza		Spain

Sponsors and Collaborators

• AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT01795352
• Other Study ID Numbers: NIS-OES-XXX-2012/1
• First Posted: Feb 20, 2013
• Last Update Posted: Oct 30, 2013
• Last Verified: Oct 1, 2013

• Keywords provided by AstraZeneca: EGFR,; lung cancer,; mutated
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Oct 30, 2013