NCT00989690

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

Randomized Proteomic Stratified Phase III Study of Second-Line Erlotinib Versus Chemotherapy in Patients With Inoperable Non Small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 275 (estimated)
• Sponsor: Istituto Scientifico H. San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	docetaxel
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

Timeline

• Start date: 2008-02-01
• First posted: 2009-10-05
• Last updated: 2013-08-12

Locations

1 site across 1 country: Italy