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

Sponsor
Istituto Scientifico H. San Raffaele
Study ID
NCT00989690
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • docetaxel — DRUG
  • erlotinib hydrochloride — DRUG
  • pemetrexed disodium — DRUG
  • fluorescence in situ hybridization — GENETIC
  • mutation analysis — GENETIC
  • proteomic profiling — GENETIC
  • immunohistochemistry staining method — OTHER
  • laboratory biomarker analysis — OTHER
  • matrix-assisted laser desorption/ionization time of flight mass spectrometry — OTHER
  • breath test — PROCEDURE

Study Details

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.

Key Dates

First listed
Oct 5, 2009
Start date
Feb 29, 2008
Status verified
Oct 2009

Study Design

Enrollment
275 participants (estimated)
Allocation
RANDOMIZED
Primary purpose
TREATMENT

Primary Outcome Measure

Overall survival

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