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

University of Utah40 enrolled

Overview

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.

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)

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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.

Time frame: 6 months

Secondary Outcomes

Overall Survival

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

Time frame: 24 months