A Study to Assess the Survival of Non-small Cell Lung Cancer Patients Treated With Tarceva After Failed Chemotherapy Treatment

Terminated

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

• Registration Number: NCT01990261
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This study will evaluate the survival of non-small cell lung cancer (wild-type EGFR) participants treated with Tarceva after at least one failed chemotherapy treatment, and the impact of prior chemotherapy treatments.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-10-31
• Study First Submitted QC: 2013-11-20
• Study First Posted: 2013-11-21
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2016-06
• Results First Submitted: 2016-06-17
• Results First Submitted QC: 2016-06-17
• Results First Posted: 2016-07-28
• Last Update Submitted: 2016-08-08
• Last Update Posted: 2016-09-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Adults >/= 18 years
• Histologically documented locally advanced, metastatic, or recurrent non-small cell lung carcinoma with wild-type EGFR eligible for Tarceva treatment.
• At least one failed chemotherapy treatment.

Exclusion Criteria

• Unknown EGFR mutation status

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Erlotinib	Erlotinib	Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.

Primary Outcome Measures

Name	Time	Method
Survival Rate at Month 6	Month 6
Survival Rate at Month 12	Month 12
Progression Free Survival (PFS) at Month 6	From inclusion up to disease progression or death whichever occurs first (up to 6 months)	PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines.
Progression Free Survival (PFS) at Month 12	From inclusion up to disease progression or death whichever occurs first (up to 12 months)	PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to 12 months	OS is defined as time from first administration of study drug until death from any cause.
Percentage of Participants With Adverse Events (AEs)	Up to 12 months	An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Overall Survival According to Prior Chemotherapy Treatment.	Up to 12 months	Prior chemotherapy treatment is presented as reported by the investigators.