Pathomolecular Analysis of Rare EGFR Mutations in Advanced NSCLC

Mutations in Exons 18 to 21 Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01215474
• Other study ID #: AZ-NSCLC 18+
• Status: Completed
• Phase: N/A
• First received: October 5, 2010
• Last updated: June 15, 2011

Study information

• Verified date: October 2010
• Source: Provitro GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

While current mutational analyses comprise exons 19 and 21 in which the majority of EGFR-mutations occur, this study aims at investigating the relevance of exon 18 and 20 mutations. Therefore, the investigators analyse 500 routine tumor samples with respect to the above mentioned exons and correlate the results to the clinical outcome. This approach will enable us to potentially identify patients that might in the future benefit from targeted therapy (EGFR-inhibition).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• NSCLC Stadium III-IV

Exclusion Criteria:

• no NSCLC or different stadium

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Mutations in Exons 18 to 21

Locations

Country	Name	City	State
Germany	Institute of Pathology, Charité University Medicine Berlin	Berlin

Sponsors (3)

Lead Sponsor	Collaborator
Provitro GmbH	AstraZeneca, Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany,