At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 57 enrolled

Drug / intervention

erlotinibdrug

Likely dose

Erlotinib 150–200 mg daily (dose-escalation or de-escalation based on rash development and body weight)AI-extracted

Key inclusion· 5

✓Histologically or cytologically confirmed stage IIIB or IV NSCLC
✓Prior treatment with 1-2 platinum- or taxane-containing chemotherapy regimens
✓Measurable disease
✓African American

Key exclusion· 3

✕Known brain metastases
✕Prior treatment with EGFR-targeting therapies
✕Pregnant or lactating women

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00230126

NCT00230126Phase 2Completed

Compare CT.gov

A Phase II Randomized Study of OSI-774 in African American Patients With Advanced and Previously Treated Non-Small Cell Lung Cancer (NSCLC)

Ohio State University Comprehensive Cancer Center·interventional·Posted Sep 30, 2005·Updated Dec 26, 2017

In Brief

A Phase 2 clinical trial evaluating erlotinib for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 57 participants across 1 site.

Detailed Summary

This study determines tumor response rate, time to tumor progression and survival rate at 1 year produced by OSI-774 in previously treated African American patients with nonsmall cell lung cancer.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsCarcinoma, Non-Small-Cell Lung

CountriesUnited States

CollaboratorsGenentech, Inc.

Timeline

Phase 2CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

First PostedSep 2005

Enrollment StartOct 2005

Primary CompletionSep 2011

Study CompletionJul 2013

TodayJul 2026

First PostedSep 30, 2005

Enrollment StartOct 1, 2005

Primary CompletionSep 1, 2011

Study CompletionJul 1, 2013

TodayJul 2, 2026

Enrollment to primary: 5.9 yearsPosted 20.8 years ago

Interventions

erlotinibdrug

Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day.