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

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No specific intervention

Other

Clinical, drug and data collection : characteristics of patients (age, sex and histology), non HER 2-directed treatments including response and duration of response

Primary outcomes

Overall response rate

Time frame: 24 months

Secondary outcomes

Median progression-free survival (PFS) with conventional chemotherapy

Time frame: 24 months

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Jul 11, 2016
Registry last updated: Jul 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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