A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (TRIGGER)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2017-01-31

Brief Summary

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This single-arm, open-label study evaluated the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic non-small cell lung cancer. Participants received daily oral doses of 150 mg Tarceva. The anticipated time on study treatment was 12 months.

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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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Single Arm

Group Type EXPERIMENTAL

erlotinib

Intervention Type DRUG

150 mg orally once a day for 12 months

Interventions

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erlotinib

150 mg orally once a day for 12 months

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
* Locally advanced or metastatic non-small cell lung cancer
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Life expectancy over \>/=12 weeks
* Adequate hematological, liver, or kidney function

Exclusion Criteria

* Previous therapy against epidermal growth factor receptor for metastatic disease
* Treatment with investigational drug during the 3 weeks before enrollment
* History of neoplasm
* Patients with symptomatic cerebral metastases
* Unstable systemic disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No