400
Participants
Start Date
April 12, 2010
Primary Completion Date
April 29, 2014
Study Completion Date
December 31, 2017
NGR-hTNF plus Best Investigator's Choice (BIC)
"* NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.~* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis~* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:~ 1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles~ 2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles~ 3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)"
Placebo plus Best Investigator's Choice (BIC)
"* Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.~* Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis~* Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:~ 1. Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles~ 2. Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles~ 3. Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)"
Institut Jules Bordet, Brussels
Cliniques Universitarie St. Luc, Brussels
St. Antonius Hospital, Nieuwegein
St. Jansdal Hospital, Harderwijk
Centre Hospitalier Universitaire de Liège, Liège
Universitair Ziekenhuis, Ghent
Columbia University, New York
Azienda Ospedaliera Universitaria San Luigi Gonzaga, Orbassano
National Cancer Institute, Cairo
Ospedale Santo Spirito, Casale Monferrato
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria, Alessandria
Istituto Nazionale per la Ricerca sul Cancro, Genoa
University of Pennsylvania, Philadelphia
Azienda Ospedaliera San Gerardo, Monza
Fondazione San Raffaele del Monte Tabor, Milan
Johns Hopkins, Baltimore
H. Lee Moffitt ancer Center and Research Institute, Tampa
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-IRST, Meldola
Azienda Unità Sanitaria locale di Ravenna, Ravenna
Azienda Ospedaliera Senese, Siena
UTsouthwestern medical center, Dallas
Medical University of Gdansk, Gdansk
City of Hope-Comprehensive Cancer Cente, Duarte
Wilshire Oncology Medical Group, Corona
Antwerp University Hospital, Edegem
UAB - Alberta Cancer Board - Cross Cancer Institute, Edmonton
University Health Network, Princess Margaret Hospital, Toronto
Hôpitaux de Marseille Hôpital Nord, Marseille
St James's Hospital, Dublin
Centro di Riferimento Oncologico, Aviano
Ospedale Valduce, Como
Azienda Ospedaliero-Universitaria Careggi di Firenze, Florence
Istituto Oncologico Veneto, Padua
Azienda Ospedaliero Universitaria di Parma, Parma
A.O. Salvini Garbagnate, Ospedale di Rho, Rho
The Royal Marsden Hospital, Sutton
Maria Sklodowska Memorial Cancer Center and Institute of Oncology, Warsaw
Hospital Universitari Germans Trias i Pujol, Badalona
Hospital Vall d'Hebron, Barcelona
The University Hospital, Linköping
Chest Clinic, Wythenshawe Hospital, Manchester
Kent Oncology Centre Maidstone Hospital, Maidstone
University Hospitals of Leicester, Leicester
Mount Vernon Cancer Centre, Middlesex
Edinburgh Cancer Centre, Western General Hospital, Edinburgh
The Beatson West of Scotland Cancer Centre, Glasgow
Castle Hill Hospital, Cottingham
Guy's Hospital, London
The Royal Marsden Hospital, London
Lead Sponsor
AGC Biologics S.p.A.
INDUSTRY