A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations

Roche

Status and phase: Completed; Phase 2

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Treatments: Drug: Erlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01260181

ML25434

2010-022509-17

Details and patient eligibility

About

This single arm, open-label study will evaluate the efficacy and safety of erlotinib (Tarceva) in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Locally advanced or metastatic NSCLC with EGFR mutations
• Measurable disease according to RECIST criteria
• Adequate hematological, renal and liver function

Exclusion criteria

• Previous chemotherapy or therapy against EGFR for metastatic disease
• Symptomatic cerebral metastases
• Pre-existing disease of the lung parenchyma such as lung fibrosis, lymphangitic carcinomatosis
• History of another malignancy except for carcinoma in-situ of the cervix, adequately treated basal cell skin carcinoma, or radically treated prostate carcinoma with good prognosis
• Concomitant use of coumarins

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Erlotinib

Experimental group

Description:

Participants will receive erlotinib 150 millgrams (mg) orally daily until disease progression.

Treatment:

Drug: Erlotinib