A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present EGFR Mutations

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-11-30

Brief Summary

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This single arm, open-label study will assess the efficacy and safety of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations. Patients will receive Tarceva at a dose of 150 mg daily orally 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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

Group Type EXPERIMENTAL

erlotinib [Tarceva]

Intervention Type DRUG

150 mg daily orally

Interventions

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erlotinib [Tarceva]

150 mg daily orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients, \>/=18 years of age
* Locally advanced or metastatic (stage III/IV) non-small cell lung cancer with EGFR mutations
* Measurable disease according to RECIST criteria
* ECOG performance status 0-2
* Adequate haematological, renal and liver function

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No