Study of Blood and Tissue Samples in Predicting Response to Second-Line Therapy Using Erlotinib Hydrochloride or Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer
RATIONALE: Studying the proteins expressed in samples of blood and tissue from patients with cancer may help doctors identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This randomized phase III trial is studying blood and tissue samples in predicting response to second-line therapy using erlotinib hydrochloride or chemotherapy in patients with advanced non-small cell lung cancer.
Drug: erlotinib hydrochloride
Drug: pemetrexed disodium
Genetic: fluorescence in situ hybridization
Genetic: mutation analysis
Genetic: proteomic profiling
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry
Procedure: breath test
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Proteomic Stratified Phase III Study of Second-Line Erlotinib Versus Chemotherapy in Patients With Inoperable Non Small Cell Lung Cancer|
- Overall survival
- Progression-free survival
- Overall response rate according to RECIST criteria
|Study Start Date:||February 2008|
- 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 mutation).
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 hydrochloride.
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 profile.
After completion of study treatment, patients are followed every 2 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00989690
|Istituto Scientifico H. San Raffaele||Recruiting|
|Milan, Italy, 20132|
|Contact: Vanesa Gregor, MD 39-02-2643-7623|
|Principal Investigator:||Vanesa Gregor, MD||Istituto Scientifico H. San Raffaele|