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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2017-09-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-Squamous Non-Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Erlotinib

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

Group Type EXPERIMENTAL

Erlotinib

Intervention Type DRUG

Erlotinib 150 mg tablet will be given orally daily.

Interventions

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Erlotinib

Erlotinib 150 mg tablet will be given orally daily.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No