A Study of First or Second Line Treatment With Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer

Phase 4

Completed

• Conditions: Non-Squamous Non-Small Cell Lung Cancer
• Interventions: Drug: erlotinib [Tarceva]

• Registration Number: NCT01066884
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This single arm study will assess the safety and efficacy of Tarceva monotherapy in patients with advanced non-small cell lung cancer. Patients will receive Tarceva 150mg p.o. daily. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Study First Submitted: 2010-02-04
• Study First Submitted QC: 2010-02-09
• Study First Posted: 2010-02-10
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-22
• Last Update Posted: 2016-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• adult patients >= 18 years of age;
• inoperable, locally advanced, recurrent or metastatic (Stage IIIB/IV) non-small cell lung cancer;
• ECOG performance status of 0-3;
• previously untreated, or failed on one prior course of standard systemic chemotherapy and/or radiotherapy.

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Exclusion Criteria

• prior systemic anti-tumor therapy with HER1/EGFR inhibitors;
• unstable systemic disease;
• any other malignancies within 5 years (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;
• any significant ophthalmologic abnormality.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	erlotinib [Tarceva]	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs)	Length of patient on study (length of time of patient on study determined by investigator)

Secondary Outcome Measures

Name	Time	Method
Best Response Rate per investigator assessment	Length of patient on study (length of time of patient on study determined by investigator)
Overall survival	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first
Time to Progression (TTP)	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first