A Pilot Study of Preoperative Tarceva (Erlotinib) Monotherapy in Patients With Early Stage (I/II) Non-Small Cell Lung Cancer
Tarceva® (erlotinib) is a drug that blocks a receptor called the Epidermal Growth Factor
Receptor (EGFR) on certain cells including tumor cells. Blocking this receptor has been
shown to shrink tumors in some patients. Tarceva®(erlotinib) is approved for commercial use
by the U.S. Food and Drug Administration for treatment of Non-Small Cell Lung Cancer (NSCLC)
after failure of at least one chemotherapy treatment. However, it is not approved for the
first treatment of Non-Small Cell Lung Cancer (NSCLC), which is the treatment used in this
Patients with early stage non-small cell lung cancer will receive daily Tarceva® (erlotinib)
at 150 mg/day for 3 weeks followed by surgical resection at week 4. High resolution CT scans
for tumor response assessment will be obtained at baseline and after 3 weeks of treatment
with Tarceva® (erlotinib). Post-operative 2-year treatment with Tarceva® (erlotinib) will
be offered to patients who had at least a 50% (half) decrease in size of their tumor after
treatment with Tarceva® (erlotinib)and/or patients with tumors that were found to have the
receptor, Epidermal Growth Factor Receptor (EGFR), on their tumor cells at the time of their
Post-operative chemotherapy will be administered at the discretion of the treating physician
to patients with stages IB and II. Patients who receive post-operative chemotherapy will
begin Tarceva (erlotinib)no sooner than 3 weeks from Day 1 of the last chemotherapy cycle
and no longer than 6 months after surgery. Follow-up for recurrence and survival will
continue for 2 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate Defined as the Percentage of Subjects Achieving at Least 50% Tumor Volume Reduction.
High resolution CT scans for response assessment were obtained at baseline and within 1 week after completion of erlotinib treatment. Volumetric and maximum diameter (RECIST) response criteria was determined by a radiologist blinded to the sequence of treatment. Response rate (RR) is defined as the percentage of subjects achieving at least 50% tumor volume reduction.
High resolution CT scans for response assessment will be obtained after 3 weeks of treatment with Tarceva®.
Nasser K Altorki, MD
Weill Medical College of Cornell University
United States: Institutional Review Board
OSI TAR 728
|Weill Medical College of Cornell University||New York, New York 10021|