Non Small Cell Lung Cancer Clinical Trial
Official title:
An Exploratory Study of the Performance of Mass-Spectrometry Based Test Veristrat in Prediction of Benefit of First Line NSCLC Patients From Treatment With Standard Chemotherapy Regimens
VeriStrat® is a pretreatment blood-based test correlated with clinical outcome after
EGFR-TKI therapy in non-small cell lung cancer (NSCLC) patients.
The investigators hypothesis is that VeriStrat could be also employed as a biomarker of
benefit from treatment with standard chemotherapy regimens in first line NSCLC patients.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | March 2018 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically or cytologically documented inoperable, locally advanced (stage IIIb with supraclavicular lymph node metastases),metastatic (stage IV) or recurrent NSCLC - Age =18 years - Life expectancy more than 3 months - ECOG performance status 0-1 - At least one unidimensionally measurable lesion (as per RECIST criteria ver 1.1) - Adequate baseline bone marrow, hepatic and renal function - Patients may have had prior therapy providing the following conditions are met: Radiation therapy: wash-out period of 28 days; Surgery: wash-out period of 14 days - Patients must give written informed consent to participate in the study Exclusion Criteria: - Prior chemotherapy or treatment with another systemic anti-cancer agent (for example tyrosine kinase inhibitor). - Patients must not receive any other investigational agents while on study - Patients with myocardial infarction within the last six (6) months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication - History or evidence upon physical examination of CNS disease unless adequately treated (e.g., any brain metastasis, seizure not controlled with standard medical therapy, or history of stroke). - Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol - Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol - Pregnancy or lactation. Patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro | Genoa |
Lead Sponsor | Collaborator |
---|---|
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival | The primary objective of this study is to evaluate the potential role of VeriStrat test as a biomarker of benefit from treatment with standard chemotherapy regimens in first line NSCLC patients in terms of progression-free survival (PFS) (primary endpoint) in two populations: patients with non-squamous histology treated with cisplatin and pemetrexed, and patients with squamous histology treated with cisplatin and gemcitabine | 2 years | |
Secondary | Overall survival | A secondary endpoint is to evaluate the role of VeriStrat as a biomarker of the secondary endpoints overall survival, in two groups of first line patients with non-small cell lung cancer (NSCLC), described above. | 2 years | |
Secondary | Correlation with RECIST response | A secondary endpoint is to evaluate the possible correlation of VeriStrat classification with best RECIST responses. | Every 6 weeks | |
Secondary | Correlation with known biomarkers | A secondary endpoint is to evaluate the possible correlation of VeriStrat classification with the available measurements of known biomarkers: the mutation statutes of EGFR, K-RAS, and ALK, and levels of ERCC1, RRM1 and TS. | Every 6 weeks | |
Secondary | Changes of VeriStrat with disease progression | A secondary endpoint is to evaluate possible changes of VeriStrat classification with disease progression. | Every 6 weeks | |
Secondary | Metabolomics | A secondary endpoint is to identify, measure, and interpret the complex time-related concentrations, activity, and fluxes of endogenous metabolites in biosamples such as blood and urine to improve disease prognosis and monitoring; provide insight into drug metabolism and toxicology; provide a linkage between the human metabolome and the human genome and proteome. | Every 6 weeks | |
Secondary | Circulating tumor cells. | A secondary endpoint is isolate, identify and characterize molecularly the circulating tumor cells (CTCs) before start of treatment (within 2 weeks), at each patient's evaluation and at progression. | Every 6 weeks |
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