NCT00989690

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
275

participants targeted

Target at P25-P50 for phase_3 lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2009

Completed
Last Updated

August 12, 2013

Status Verified

October 1, 2009

First QC Date

October 2, 2009

Last Update Submit

August 9, 2013

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival

Secondary Outcomes (2)

  • Progression-free survival

  • Overall response rate according to RECIST criteria

Interventions

docetaxelDRUG
erlotinib hydrochlorideDRUG
pemetrexed disodiumDRUG
fluorescence in situ hybridizationGENETIC
mutation analysisGENETIC
proteomic profilingGENETIC
immunohistochemistry staining methodOTHER
laboratory biomarker analysisOTHER
matrix-assisted laser desorption/ionization time of flight mass spectrometryOTHER
breath testPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Istituto Scientifico H. San Raffaele

Milan, 20132, Italy

RECRUITING

Related Publications (1)

  • Gregorc V, Novello S, Lazzari C, Barni S, Aieta M, Mencoboni M, Grossi F, De Pas T, de Marinis F, Bearz A, Floriani I, Torri V, Bulotta A, Cattaneo A, Grigorieva J, Tsypin M, Roder J, Doglioni C, Levra MG, Petrelli F, Foti S, Vigano M, Bachi A, Roder H. Predictive value of a proteomic signature in patients with non-small-cell lung cancer treated with second-line erlotinib or chemotherapy (PROSE): a biomarker-stratified, randomised phase 3 trial. Lancet Oncol. 2014 Jun;15(7):713-21. doi: 10.1016/S1470-2045(14)70162-7. Epub 2014 May 13.

    PMID: 24831979DERIVED

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

DocetaxelErlotinib HydrochloridePemetrexedIn Situ Hybridization, FluorescenceImmunohistochemistry

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGuanineHypoxanthinesPurinonesPurinesGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicIn Situ HybridizationStaining and LabelingHistocytological Preparation TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesCytogenetic AnalysisGenetic TechniquesNucleic Acid HybridizationHistocytochemistryImmunologic Techniques

Study Officials

  • Vanesa Gregor, MD

    Istituto Scientifico H. San Raffaele

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 2, 2009

First Posted

October 5, 2009

Study Start

February 1, 2008

Last Updated

August 12, 2013

Record last verified: 2009-10

Locations

IT(1)