Phase 2
Completed N=103
Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2
Source: ClinicalTrials.gov NCT00085839 ↗Enrolled (actual)
103
Serious AEs
35.9%
Results posted
Apr 2011
Primary outcomePrimary: Progression-free Survival — 1.91; 3.52 months
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
1.91; 3.52 | — |
| SECONDARY Overall Survival |
6.57; 9.53 | — |
| SECONDARY Best Tumor Response |
0; 0; 2; 6; 19; 23 | — |
Eligibility Criteria
Inclusion Criteria
- Stage IIIB or IV Nonsmall cell lung cancer (NSCLC)
- No prior chemotherapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status 2
- Clinically or radiologically measurable disease per RECIST criteria
Exclusion Criteria
- Gastro-intestinal abnormalities
- Any concurrent anticancer therapy
- Prior treatment with epidermal growth factor receptor (EGFR) inhibitors of any kind
- Other active malignancies
- Uncontrolled brain metastases
- Severe abnormalities of the cornea
- Significant cardiac disease
Data sourced from ClinicalTrials.gov (NCT00085839). 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.