Lung Cancer Clinical Trial
A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC).
Summary
This 4 arm study in patients with advanced Stage IIIb/IV non-small cell cancer (NSCLC) who failed at least one standard chemotherapy regimen will determine the proportion of patients with progression-free survival at 12 weeks following combination therapy with R1507 and Tarceva or placebo and Tarceva. Patients will be randomized to one of four treatment arms to receive R1507 (9mg/kg iv) or placebo weekly or R1507 (16mg/kg iv) or placebo every 3 weeks. Tarceva (150mg oral daily) will be administered in all treatment arms. Other disease-related endpoints including overall survival, objective response rate, time to response, time to progressive disease and duration of response will also be evaluated. The anticipated time on study treatment is 1-2 years, and the target sample size is <500 individuals.
Eligibility Criteria
Inclusion Criteria:
male or female patients >=18 years with histologically documented inoperable, locally advanced or metastatic (stage IIIB or IV) NSCLC;
patients must have failed at least one but no more than two standard chemotherapy regimens;
measurable disease according to the RECIST criteria;
Eastern Cooperative Oncology Group (ECOG) performance status;
life expectancy >12 weeks.
Exclusion Criteria:
patients with active central nervous system (CNS) lesions;
prior treatment with agents acting via insulin-like growth factor 1 receptor (IGF-1R) inhibition or epidermal growth factor receptor (EGFR) targeting;
administration with high doses of systemic corticosteroids;
radiotherapy in the 4 weeks prior to study start;
surgery or significant traumatic injury with in the last 2 weeks prior to study start.
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There are 57 Locations for this study
Beverly Hills California, 90211, United States
New Port Richey Florida, 34655, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60637, United States
Glenview Illinois, 60026, United States
Joliet Illinois, 60435, United States
Towson Maryland, 21204, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02215, United States
Hackensack New Jersey, 07601, United States
Hickory North Carolina, 28602, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37203, United States
Richmond Virginia, 23226, United States
Adelaide South Australia, 5041, Australia
Frankston Victoria, 3199, Australia
Nedlands Western Australia, 6009, Australia
Bruxelles , 1200, Belgium
Charleroi , 6000, Belgium
Edegem , 2650, Belgium
Leuven , 3000, Belgium
Liege , 3500, Belgium
Oshawa Ontario, L1G 2, Canada
La Tronche , 38700, France
Lyon , 69317, France
Paris , 75674, France
Paris , 75970, France
Toulouse , 31400, France
Bad Berka , 99437, Germany
Berlin , 14165, Germany
Großhansdorf , 22927, Germany
Halle (Saale) , 06120, Germany
Hamburg , 21075, Germany
Heidelberg , 69126, Germany
Herne , 44625, Germany
Leverkusen , 51375, Germany
Muenchen , 80336, Germany
Dublin , 8, Ireland
Reggio Emilia Emilia-Romagna, 42100, Italy
Genova Liguria, 16132, Italy
Milano Lombardia, 20162, Italy
Orbassano Piemonte, 10043, Italy
Sant'Andrea Delle Fratte (PG) Umbria, 06132, Italy
Gdansk , 80-95, Poland
Poznan , 60-56, Poland
Szczecin , 70-89, Poland
Warszawa , 02-78, Poland
Majadahonda Madrid, 28222, Spain
Bilbao Vizcaya, 48903, Spain
Barcelona , 08036, Spain
Barcelona , 08041, Spain
Malaga , 29010, Spain
Guildford , GU2 7, United Kingdom
Manchester , M23 9, United Kingdom
Newcastle Upon Tyne , NE7 7, United Kingdom
Wolverhampton , WV10 , United Kingdom
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