A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Following 4 Cycles of Platinum-based Chemotherapy Without Disease Progression

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This open-label, single-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer who have completed 4 cycles of standard platinum-based chemotherapy without progression. Patients will receive Tarceva at a dose of 150 mg orally daily until disease progression or unacceptable toxicity occurs.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

• Adult patients ≥ 18 years of age.

• Histologically documented non-small cell lung cancer (NSCLC).

• Locally advanced or recurrent (Stage IIIB) or metastatic (Stage IV) disease.

• Completion of 4 cycles of an acceptable, standard, platinum-based chemotherapy doublet without progression.

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

• Patients of reproductive potential must agree to use effective contraception.

Exclusion Criteria:

• Prior exposure to agents directed at the human epidermal growth factor receptor (HER) axis (eg, gefitinib, cetuximab, trastuzumab).

• Prior treatment with any monoclonal antibody therapy.

• Any other malignancies within the previous 5 years, except for adequately treated carcinoma in situ of the cervix or squamous cell skin cancer.

• Clinically significant cardiovascular, hepatic, renal, or metabolic disease or active infection

• Pre-existing interstitial lung disease.

• Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.

• Pregnant or lactating women.