Status:
COMPLETED
NGR-hTNF in Combination With Standard Chemotherapy to Treat Patients With Advanced Non-small Cell Lung Cancer
Lead Sponsor:
AGC Biologics S.p.A.
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
Eligible patients will be randomly assigned to a standard chemotherapy regimen plus low-dose (0.8 mcg/m\^2) NGR-hTNF or standard chemotherapy alone, through a centralized randomization process using t...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- Age ≥18 years
- Life expectancy more than 3 months
- ECOG performance status 0-1
- At least one unidimensional measurable lesion (as per RECIST criteria)
- 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
- 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 monoclonal antibody, 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
- Uncontrolled hypertension
- Prolonged QTc interval (congenital or acquired)
- Patient with significant peripheral vascular disease
- 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).
- Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
- Known hypersensitivity/allergic reaction or contraindications to human albumin preparations or to any of the excipients
- 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 child-bearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00994097
Start Date
July 1 2009
End Date
March 1 2017
Last Update
September 27 2018
Active Locations (4)
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1
Istituto Nazionale per la ricerca sul cancro
Genoa, Italy, 16132
2
Fondazione San Raffaele del Monte Tabor
Milan, Italy, 20132
3
Istituto Nazionale dei Tumori
Milan, Italy, 20133
4
Istituto Europeo Oncologico
Milan, Italy