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Veristrat as Predictor of Benefit of First Line Non Small Cell Lung Cancer (NSCLC) Patients From Standard Chemotherapy

Sponsored by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

About this trial

Last updated 8 years ago

Study ID

VERISTRAT/IST

Status

Unknown status

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 7 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status

Recruiting