Phase 2 Completed N=40 Treatment

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

Source: ClinicalTrials.gov NCT00585533 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2012

Primary outcomePrimary: Survival Rate at 6-months Chemotherapy-progression-free (CP-free) — 55 percentage of participants

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Survival Rate at 6-months Chemotherapy-progression-free (CP-free)	55	—
SECONDARY Overall Survival	50.1	—

Eligibility Criteria

Inclusion Criteria

Performance status 0-1.
Weight Loss 6 months from protocol entry
Adequate Organ Function
Liver enzymes 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00585533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.