Study of Erlotinib With Docetaxel in Selected Non Small Cell Lung Cancer Patients in First Line Treatment
Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
Participant gender:
Summary
Study Rationale:
There is increasing evidence that erlotinib improves overall survival in selected patients
with stage IIIB-IV NSCLC. Furthermore, pre-clinical and phase II studies have shown a
potential for synergism between erlotinib and docetaxel. This study will further evaluate the
effects of combination treatment on overall survival in selected NSCLC patient population.
Based on recent published data, the treatment cycle in this study will be 22 days with two
infusions (Day 1 and Day 8 of each cycle). This is different from the standard therapy care
of 28-day cycle (three infusions on Days 1, 8 and 15). The shorter 22-day cycle was shown to
be just as effective as the 28-day cycle and is expected to increase subject compliance and
decrease chemotherapy-induced toxicity.
Study Objectives:
The primary objective is to demonstrate superiority in progression-free-survival, when
erlotinib is added to docetaxel.
The secondary objectives are to determine:
- Overall survival (defined as the time period from the start of first-line therapy to
death)
- Time to treatment failure or disease progression (defined as the time period from the
start of first-line therapy to investigator assessed disease progression)
- Tumor response rate and duration
- Safety profile
- Quality of Life improvement
- microRNA profile (assessed from human lung biopsy and/or cytology samples) at screening
for prognostic purposes