Responses to Chemotherapy of Patients With Non-small Cell Lung Cancer Harboring a Known Somatic Activating HER2 Mutation

Completed

• Conditions: Lung Cancer

• Registration Number: NCT02827357
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

This chart review describe the response to systemic chemotherapy of patients with non-small cell lung cancer (NSCLC) harbouring a known somatic activating human epidermal growth factor receptor 2 (HER2) mutation. The analysis of this data will provide an initial description of the response to systemic chemotherapy in patients with NSCLC harboring an activating HER2 mutation in order to inform the design and powering of future randomized controlled clinical trials of HER2-directed therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-07
• Study First Submitted: 2016-07-06
• Study First Submitted QC: 2016-07-07
• Last Update Submitted: 2016-07-07
• Study First Posted: 2016-07-11
• Last Update Posted: 2016-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• patients with advanced nonsmall-cell lung cancer
• known HER2 exon-20 insertion
• treated with chemotherapy and/or HER2-targeted drugs

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall response rate	24 months

Secondary Outcome Measures

Name	Time	Method
Median progression-free survival (PFS) with conventional chemotherapy	24 months