At a glance
ClinicalIndex Comparison Record- ✓Stage IIIB or IV non-small cell lung cancer
- ✓No prior chemotherapy
- ✓ECOG performance status 2
- ✓Clinically or radiologically measurable disease by RECIST criteria
- ✕Prior treatment with any EGFR inhibitors
- ✕Uncontrolled brain metastases
- ✕Other active malignancies
- ✕Concurrent anticancer therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase II Study of Single Agent Erlotinib [Tarceva (TM), OSI-774] Versus Standard Chemotherapy in Patients With Previously Untreated Advanced NSCLC and a Poor Performance Status
In Brief
A Phase 2 clinical trial evaluating Tarceva (Trademark) (erlotinib HCl, OSI-774) and Combination carboplatin and paclitaxel for Non-Small Cell Lung Cancer. Completed, enrolled 103 participants across 19 sites.
Detailed Summary
The purpose of this noncomparative study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated nonsmall cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2. The study will also evaluate the safety of single-agent erlotinib in this patient population.
Study Details
Timeline
Interventions
Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
Paclitaxel 200 mg/m\^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles