Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Phase II Open-Label Study Designed to Evaluate the Efficacy and Safety, of Erlotinib in Combination With Docetaxel in Selected Non Small Cell Lung Cancer Patients Eligible for First Line Treatment
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
Study Design:
This will be a Phase II, open-label, single-center, repeat dose, study. After a two-week
screening phase, eligible subjects will receive combined docetaxel and erlotinib treatment
over six cycles. Each 22-day treatment cycle will consist of two infusion of docetaxel,
one-week apart followed by one week rest, and daily administration of erlotinib. Subjects,
who complete six cycles of combination therapy, will continue receiving erlotinib
monotherapy for as long as they are benefiting from this therapy in the opinion of the
investigator (i.e. until continued toxicity or disease progression or withdrawal from the
study). Subjects will be evaluated for safety and radiologic tumor assessment throughout the
study until death. The study will be terminated after every living patient has had a follow
up of at least 6 months after stopping TarcevaTM, or when all patients have died.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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