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
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00989690 |
Recruitment Status : Unknown
Verified October 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : October 5, 2009
Last Update Posted : August 12, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lung Cancer | 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 | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 275 participants |
Allocation: | Randomized |
Masking: | None (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 |
Study Start Date : | February 2008 |

- Overall survival
- Progression-free survival
- Overall response rate according to RECIST criteria

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
-
Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
- Advanced NSCLC (stage IIIB or IV)
- Measurable disease
- Underwent previous treatment with 1 non-tyrosine kinase inhibitor as first-line therapy for advanced NSCLC
- No clinical evidence of uncontrolled brain metastases
PATIENT CHARACTERISTICS:
- Caucasian
- ECOG performance status 0-2
- Absolute granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin ≤ 1.5 times upper limit of normal (ULN) (≤ 2.5 times ULN in patients with known liver metastases)
- ALT or AST ≤ 3 times ULN (≤ 5 times ULN in patients with known liver metastases)
- Creatinine clearance ≥ 50 mL/min
- Not pregnant or nursing
- Able to comply with planned study procedures
- No multiple severe diseases that can compromise safety (cardiac and renal failure, peripheral neuropathy)
- No other malignancy (except for basal cell skin carcinoma) or pre-neoplastic condition requiring chemotherapeutic treatment
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 3 weeks since prior surgery or radiotherapy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00989690
Italy | |
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 |
ClinicalTrials.gov Identifier: | NCT00989690 |
Other Study ID Numbers: |
SRSI-HSRL-02-2007 CDR0000652115 ( Registry Identifier: PDQ (Physician Data Query) ) 2007-006299-13 EU-20975 |
First Posted: | October 5, 2009 Key Record Dates |
Last Update Posted: | August 12, 2013 |
Last Verified: | October 2009 |
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Docetaxel |
Erlotinib Hydrochloride Pemetrexed Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Protein Kinase Inhibitors Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |