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

Roche

Status and phase

Completed

Phase 4

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: Erlotinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01230710

ML25478

Details and patient eligibility

About

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.

Enrollment

51 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.