Phase 2
N=143
Erlotinib (Tarceva) as a Single Agent or Intercalated With Combination Chemotherapy in Patients With EGFR Positive NSCLC
Carcinoma, Non-Small-Cell Lung
Bottom Line
View on ClinicalTrials.gov: NCT00294762 ↗Enrolled (actual)
143
Serious AEs
39.4%
Results posted
Feb 2011
Primary outcome: Primary: 6-month Progression-free Survival — 30.7; 26.4 Percentage of Patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tarceva (Drug); carboplatin (Drug); paclitaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- OSI Pharmaceuticals
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6-month Progression-free Survival |
30.7; 26.4 | — |
| SECONDARY Progression-free Survival |
2.69; 4.57 | — |
| SECONDARY Overall Survival at 12 Months |
58.6; 46.4 | — |
| SECONDARY Overall Survival |
16.72; 11.43 | — |
| SECONDARY Best Tumor Response |
0; 0; 11.6; 22.4; 34.8; 49.3 | — |
| SECONDARY Duration of Tumor Response |
6.4; 4.1 | — |
Summary
This will be the first prospective study where patients will be selected on the basis of two measures of the epidermal growth factor receptor (EGFR) pathway. The study will assess prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy in highly selected patients with EGFR overexpression and/or EGFR amplification.
Eligibility Criteria
Inclusion Criteria
- Age >= 18
- Histologically or cytologically documented non-small cell lung cancer (NSCLC)
- Eastern Cooperative Oncology Group (ECOG)performance status (PS)0, 1, 2
- Radiologically measurable or evaluable disease No prior chemotherapy
- 1 or 2 epithelial growth factor receptor (EGFR) pathway markers positive at screening
- Tumor tissue block or fine needle aspirate
Exclusion Criteria
- Any concurrent anticancer therapy or radiation
- Other active malignancy
- Uncontrolled brain metastases
- GI abnormalities
- Severe abnormalities of the cornea
- Significant cardiac disease
- Active infection
Data sourced from ClinicalTrials.gov (NCT00294762). 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.