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. MedDRA version: 9.1 Level: LLT Classification code 10061873 Term: Non-small cell lung cancer
Conditions
Interventions
Product Name: NGR-hTNF
Product Code: MM102
Pharmaceutical Form: Concentrate for solution for infusion
Other descriptive name: ARENEGYR
Concentration unit: µg/ml microgram(s)/millilitre
Concentration t
Sponsors
MOLMED
Eligibility
Sex/Gender
All
Inclusion criteria
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 unidimensionally 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect on progression-free survival (PFS) of NGR-hTNF administered at low dose (0.8 μg/m2) in combination with standard chemotherapy as compared to standard chemotherapy alone.;Secondary Objective: (1) To determine the safety profile of NGR-hTNF in combination with standard chemotherapy. (2) To evaluate the effect of NGR-hTNF in combination with standard chemotherapy on objective response rate (according to RECIST criteria), duration of response (DR), and overall survival (OS) as compared to standard chemotherapy alone.;Primary end point(s): Progression-free survival (PFS). | — |
Countries
Italy
Outcome results
None listed