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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02827357
• Other study ID #: 14 7305 03
• Status: Completed
• Phase: N/A
• First received: July 6, 2016
• Last updated: July 7, 2016
• Start date: March 2013
• Est. completion date: September 2015

Study information

• Verified date: July 2016
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with advanced nonsmall-cell lung cancer

• known HER2 exon-20 insertion

• treated with chemotherapy and/or HER2-targeted drugs

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• No specific intervention
Clinical, drug and data collection : characteristics of patients (age, sex and histology), non HER 2-directed treatments including response and duration of response

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		24 months	Yes
Secondary	Median progression-free survival (PFS) with conventional chemotherapy		24 months	Yes