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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Erlotinib

Participants received erlotinib 150 mg orally once a day for 48 weeks.

Group Type EXPERIMENTAL

Erlotinib

Intervention Type DRUG

Erlotinib was supplied as tablets.

Interventions

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Erlotinib

Erlotinib was supplied as tablets.

Intervention Type DRUG

Other Intervention Names

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Tarceva

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No