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

Completed

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Erlotinib

• Registration Number: NCT02595450
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Study First Submitted: 2015-11-02
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-03
• Status Verified: 2015-12
• Results First Submitted: 2015-12-01
• Results First Submitted QC: 2015-12-17
• Last Update Submitted: 2015-12-17
• Results First Posted: 2016-01-25
• Last Update Posted: 2016-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 299

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Erlotinib	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.

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS) Time	Up to 6 years	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.
Percentage of Participants With Best Overall Response	Up to 6 years	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS) Time	Up to 6 years	Time from the start of study treatment to date of death due to any cause. Kaplan-Meier estimates were used for calculating OS.