Non-small Cell Lung Cancer Clinical Trial
Official title:
NGR014: Randomized Phase II Study of NGR-hTNF in Combination With Standard Chemotherapy Versus Standard Chemotherapy Alone in Previously Untreated Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Verified date | August 2018 |
Source | MolMed S.p.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main objective of this study is to demonstrate superiority in progression-free survival (PFS) when NGR-hTNF is added to standard chemotherapy regimen (cisplatin/gemcitabine or cisplatin/pemetrexed) in locally advanced (stage IIIb with supraclavicular lymph node metastases or malignant pleural or pericardial effusion), metastatic (stage IV) or recurrent non-small cell lung cancer (NSCLC).
Status | Completed |
Enrollment | 121 |
Est. completion date | March 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: 1. Histologically or cytologically documented inoperable, locally advanced (stage IIIb with supraclavicular lymph node metastases or malignant pleural or pericardial effusion), metastatic (stage IV) or recurrent NSCLC. Mixed tumors should be categorized according to the predominant cell type. 2. Age =18 years 3. Life expectancy more than 3 months 4. ECOG performance status 0-1 5. At least one unidimensional measurable lesion (as per RECIST criteria) 6. Adequate baseline bone marrow, hepatic and renal function, defined as follows: - Neutrophils >1.5 x 10^9/L and platelets > 100 x 10^9/L - Bilirubin <1.5 x ULN - AST and/or ALT <2.5 x ULN in absence of liver metastasis - AST and/or ALT <5 x ULN in presence of liver metastasis - Serum creatinine <1.5 x ULN - Creatinine clearance (estimated according to Cockcroft-Gault formula) = 50 ml/min 7. 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 8. Patients must give written informed consent to participate in the study Exclusion criteria: 1. Prior chemotherapy or treatment with another systemic anti-cancer agent (for example monoclonal antibody, tyrosine kinase inhibitor). 2. Patients must not receive any other investigational agents while on study 3. 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 4. Uncontrolled hypertension 5. Prolonged QTc interval (congenital or acquired) 6. Patient with significant peripheral vascular disease 7. History or evidence upon physical examination of CNS disease unless adequately treated (e.g., primary brain tumor, any brain metastasis, seizure not controlled with standard medical therapy, or history of stroke). 8. Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol 9. Known hypersensitivity/allergic reaction or contraindications to human albumin preparations or to any of the excipients 10. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol 11. 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 child-bearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration. |
Country | Name | City | State |
---|---|---|---|
Italy | Istituto Nazionale per la ricerca sul cancro | Genoa | |
Italy | Fondazione San Raffaele del Monte Tabor | Milan | |
Italy | Istituto Europeo Oncologico | Milan | |
Italy | Istituto Nazionale dei Tumori | Milan |
Lead Sponsor | Collaborator |
---|---|
MolMed S.p.A. |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival (PFS) | PFS evaluated according to Response evaluation criteria in solid tumors (RECIST) | Every 6 weeks during study treatment and every 6 weeks during the follow-up before PD | |
Secondary | Safety according to NCI-CTCAE criteria (version 3) | To evaluate safety profile related to NGR-hTNF in combination with standard chemotherapy | from the date of randomization until 28 days after last treatment | |
Secondary | Objective response rate | Antitumor activity defined as response rate evaluated according to Response evaluation criteria in solid tumors (RECIST) | Every 6 weeks during study treatment and every 6 weeks during the follow-up before PD | |
Secondary | Duration of response (DR) | defined as the time that measurement criteria are met for complete response or partial response (whichever status is recorded first) until the progressive disease is objectively documented. | from the time of first recorded evidence of complete response or partial response until the progressive disease objectively documented | |
Secondary | Overall survival (OS) | Defined as the time from the date of randomization until the date of death due to any cause or the last date the patient was known to be alive | from the randomization until to the date of patient death or discontinuation from the study |
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