A Non-interventional Trial of Erlotinib (Tarceva) Metastatic Non-small Cell Lung Cancer

Non-Small Cell Lung Cancer Clinical Trial

Official title:

A Non Interventional Trial of Tarceva Metastatic Non Small Lung Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02595450
• Other study ID #: ML22190
• Status: Completed
• Phase: N/A
• First received: November 2, 2015
• Last updated: December 17, 2015
• Start date: September 2008
• Est. completion date: November 2014

Study information

• Verified date: December 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Medicines and Medical Devices Agency
• Study type: Observational

Clinical Trial Summary

This is a non-interventional, open label, single arm, multicenter study to assess the safety and efficacy of erlotinib in participants with non-small cell lung cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 86 Years

Eligibility

Inclusion Criteria:

• It is the physician's decision to prescribe erlotinib in participants and to document their treatment

• Participants must be candidates for receiving erlotinib for locally advanced or metastatic non-small cell lung cancer according to the product label

Exclusion Criteria:

• Participants will be excluded if safety concerns occurred

• If the participant was not compliant or if the participant would wish to stop erlotinib therapy

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

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

Intervention

Drug:
• Erlotinib
Participants with locally advanced or metastatic non-small cell lung cancer will be treated with erlotinib according to the product label. This non-interventional study will not affect by any means the treatment, medical care or monitoring of the participant, since it reports retrospective data, which already exist in the participants' medical files.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS) Time	Time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. Progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions, or unequivocal progression of existing non-target lesions. Kaplan-Meier estimates were used for calculating PFS.	Up to 6 years	No
Primary	Percentage of Participants With Best Overall Response	Percentage of participants with best overall response of complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) were reported. Per RECIST Version 1.1: CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeter [mm]). No new lesions. PR was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions, or unequivocal progression of existing non-target lesions. SD was defined as not qualifying for CR, PR, PD.	Up to 6 years	No
Secondary	Overall Survival (OS) Time	Time from the start of study treatment to date of death due to any cause. Kaplan-Meier estimates were used for calculating OS.	Up to 6 years	No