Phase 2
N=58
OSI-774 in African American Patients With Advanced and Previously Treated Non-Small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Bottom Line
View on ClinicalTrials.gov: NCT00230126 ↗Enrolled (actual)
58
Serious AEs
1.8%
Results posted
Nov 2014
Primary outcome: Primary: Disease Control Rate at 12 Weeks — 6; 6 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- erlotinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Control Rate at 12 Weeks |
6; 6 | — |
| PRIMARY Time to Progression |
2.8; 2.4 | — |
| PRIMARY 1-year Survival Rate |
30; 26 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Must have histologically or cytologically confirmed stage IIIB or IV NSCLC treated with 1-2 platinum- or taxane-containing regimens
- Measurable disease
- May have had prior surgery & external beam radiation
- African American
- 18 years or older
Exclusion Criteria
- Known brain mets
- Prior treatment with EGFR targeting therapies
- Pregnant/lactating women
Data sourced from ClinicalTrials.gov (NCT00230126). 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.