GR014: 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. - NGR014

Phase 1

• Conditions: ocally 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: 9.1Level: LLTClassification code 10061873Term: Non-small cell lung cancer

• Registration Number: EUCTR2008-002703-20-IT
• Lead Sponsor: MOLMED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-12
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 102

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 &#8805; 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 <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) &#8805; 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified