Randomized Proteomic Stratified Phase III Study of Second-Line Erlotinib Versus Chemotherapy in Patients With Inoperable Non Small Cell Lung Cancer
- To evaluate the predictive value of proteomic profiling on the effect of second-line
therapy with erlotinib hydrochloride vs standard chemotherapy (pemetrexed disodium or
docetaxel) in patients with advanced non-small cell lung cancer.
- To assess the role of other known tissue-based predictive markers (e.g., EGFR-gene copy
number, EGFR-protein expression, pAkt, pMAPK, EGFR mutations, EMT markers, and k-Ras
OUTLINE: This is a multicenter study. Patients are stratified according to smoking status,
performance status, proteomic profile, and participating center. Patients are randomized to
1 of 2 treatment arms.
- Arm I: Patients receive standard chemotherapy with pemetrexed disodium, docetaxel, or
another standard drug.
- Arm II: Patients receive standard non-chemotherapy treatment with erlotinib
Serum is collected after failure of first-line therapy for proteomic analysis by
matrix-associated laser desorption/ionization-time of flight. Tissue and blood samples are
collected periodically for analysis including EGFR based on IHC and FISH, EGFR and k-Ras
mutations, pAkt, pMAPK by IHC, and EMT markers based on IHC and breath condensate protein
After completion of study treatment, patients are followed every 2 months.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Vanesa Gregor, MD
Istituto Scientifico H. San Raffaele