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

NCT02055144 | Unknown

• 1 other identifier: VERISTRAT/IST
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLC; VeriStrat; chemotherapy; circulating tumor cells

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Overall survival

  2 years

• Correlation with RECIST response

  Every 6 weeks

• Correlation with known biomarkers

  Every 6 weeks

• Changes of VeriStrat with disease progression

  Every 6 weeks

• Metabolomics

  Every 6 weeks

Study Arms (2)

Non squamous histology

patients with advanced, non-squamous non-small cell lung cancer treated with cisplatin (or carboplatin) and pemetrexed. Maintenance with pemetrexed is allowed.

Squamous histology

patients with advanced squamous non-small cell lung cancer treated with cisplatin (or carboplatin) and gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by advanced non small cell lung cancer who are chemotherapy-naive and candidates for first-line chemotherapy. This population includes patients with non-squamous histology and patients with squamous histology.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy: lead

Study Sites (1)

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro

Genoa, 16132, Italy

RECRUITING

Related Publications (1)

• Morbelli S, Alama A, Ferrarazzo G, Coco S, Genova C, Rijavec E, Bongioanni F, Biello F, Dal Bello MG, Barletta G, Massollo M, Vanni I, Piva R, Nieri A, Bauckneht M, Sambuceti G, Grossi F. Circulating Tumor DNA Reflects Tumor Metabolism Rather Than Tumor Burden in Chemotherapy-Naive Patients with Advanced Non-Small Cell Lung Cancer: 18F-FDG PET/CT Study. J Nucl Med. 2017 Nov;58(11):1764-1769. doi: 10.2967/jnumed.117.193201. Epub 2017 Apr 27.

  PMID: 28450567 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples, urine samples, circulating tumour cells from peripheral blood. Such samples will be obtained before start of treatment (within 2 weeks), and at each patient's evaluation and at progression

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Francesco Grossi, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Grossi, MD

CONTACT

+39 010 5600 385

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: February 4, 2014
• Study Start: February 1, 2011
• Primary Completion: July 1, 2017
• Study Completion: March 1, 2018
• Last Updated: March 7, 2017

Record last verified: 2017-03

Locations

IT (1)