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NCT Number: NCT00585533

A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer

This study will evaluate Tarceva in a selected population of patients with untreated advanced non-small cell lung cancer who are anticipated to have a relatively good (indolent) prognosis based on clinical criteria. It is anticipated that selection will enrich for tumor characteristic that are likely to be benefited by EGFR inhibitor treatment (survival greater than 90 days). The goal of this strategy is to provide a less toxic, oral treatment for patients with advanced NSCLC that will not interfere with patients receiving chemotherapy at some point in the future and may prolong the time to chemotherapy related progression.

Patients will remain on study until disease progresses, a decline in performance status, if patient cannot tolerate the side effects or develops symptoms requiring conventional chemotherapy.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Utah

Salt Lake City, Utah, 84112, United States

About this study

Primary Objective To determine Time to Chemotherapy Progression (ie includes time on Tarceva monotherapy and chemotherapy) in advanced NSCLC

Secondary Objectives To evaluate survival and response rate associated with Tarceva treatment To study the frequency of symptom improvement (Lung Cancer Subscale)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Performance status 0-1.
  • Weight Loss < 10% in preceding 3 months
  • Age 18 years and older.
  • Adjuvant chemotherapy allowed if > 6 months from protocol entry
  • Adequate Organ Function
  • Liver enzymes < 2X normal, bilirubin = normal
  • Oxygen saturation> 89% on room air unless chronically oxygen dependent (not cancer related)
  • Creatinine <2.0 mg

Exclusion criteria

  • Not pregnant or lactating.
  • No Clinical Brain Metastases
  • No prior chemotherapy for systemic disease
  • Imminent need for chemotherapy for impending organ dysfunction is not allowed

Treatment and study plan

Erlotinib (Tarceva)

Drug

Erlotinib

Other names: Tarceva

Primary outcomes

  1. Survival Rate at 6-months Chemotherapy-progression-free (CP-free)

    Time frame: 6 months

    Will determine if 6-month chemotherapy-progression-free (CP-free) survival rate (using RECIST) is significantly higher than the historically observed 31%. A one-sided binomial test at a 5% nominal significance was used.

Secondary outcomes

  1. Overall Survival

    Time frame: 24 months

    Estimated via a Kaplan-Meier curves. Survival will be counted from the first dose of Tarceva.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2004
Primary completion
2012
Study completion
2012
First posted
Jan 3, 2008
Registry last updated
Jul 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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