Multicenter Phase II Study Evaluating Docetaxel, CDDP, and Cetuximab as Induction Regimen Prior to Surgery in Chemo-naive Patients With NSCLC Stage IB, II and IIIA
Primary objective is to assess the overall response rate (ORR) after induction therapy with
docetaxel in combination with CDDP and cetuximab in patients with NSCLC stage IB, II, and
IIIa. ORR will be determined by the percentage of patients achieving objective response
rates (CR + PR) according to the RECIST guidelines.
Secondary objective is
- To evaluate pathological response determined by histological work up of the surgical
specimens according to TNM stages.
- To evaluate the metabolic response determined by PET analysis.
- To assess overall survival (OS) (median survival time and percentage of 1-year
survival). OS is defined as time elapsed from the date of patient inclusion until
recorded date of death.
- To characterize and quantify toxic effects of the scheduled therapy. Safety profile and
tolerability will be assessed by recording adverse events, clinically significant
laboratory abnormalities, physical examination and vital signs. Toxicities will be
evaluated according to the NCI-CTC Toxicity Criteria and adverse events which are not
reported in NCI-CTC will be graded as mild, moderate, severe or life-threatening. All
patients who received any of the scheduled therapy will be included in the overall
- To evaluate the immunological response determined by regulatory T-cells and immune
activation markers, to define chemoresistance by pharmacogenomic testing.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
overall response rate (complete plus partial response) according to RECIST guidelines
Wolfgang Hilbe, Prof. Dr.
University Hospital Innsbruck, Internal Medicine
Austria: Agency for Health and Food Safety