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

Roche

Status and phase: Completed; Phase 4

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Treatments: Drug: erlotinib [Tarceva]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01066884

ML20569

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

1

Experimental group

Treatment:

Drug: erlotinib [Tarceva]