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).
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Non-Squamous Non-Small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT00760929
- Run by
- Hoffmann-La Roche
- People needed
- 171
- Starts
- 2008-11-10
- Expected to finish
- 2010-06-25
- Last updated by the study team
- 2021-01-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Florida Cancer Inst. — New Port Richey, Florida, United States
- Emory Univ Winship Cancer Inst — Atlanta, Georgia, United States
- University of Chicago Medical Center; Dept. of Medicine/Section of Nephrology — Chicago, Illinois, United States
- North Shore University Health System — Glenview, Illinois, United States
- Joliet Oncology Hematology Associates, Ltd. — Joliet, Illinois, United States
- St. Joseph Medical Center — Towson, Maryland, United States
- Massachusetts General Hospital. — Boston, Massachusetts, United States
- Dana Farber Cancer Inst. — Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Hackensack University Medical Center — Hackensack, New Jersey, United States
- Carolina Oncology Specialists, PA - Hickory — Hickory, North Carolina, United States
- Chattanooga Oncology and Hematology Associates, PC — Chattanooga, Tennessee, United States
- Sarah Cannon Research Inst. — Nashville, Tennessee, United States
- Virginia Cancer Institute — Richmond, Virginia, United States
- Flinders Medical Center; Medical Oncology — Adelaide, South Australia, Australia
- Frankston Hospital; Oncology/Haematology — Frankston, Victoria, Australia
- Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia
- Cliniques Universitaires St-Luc — Brussels, Belgium
- GHdC Site Notre Dame — Charleroi, Belgium
- UZ Antwerpen — Edegem, Belgium
- UZ Leuven Gasthuisberg — Leuven, Belgium
- Chr de La Citadelle — Liège, Belgium
- Lakeridge Health Oshawa; Oncology — Oshawa, Ontario, Canada
- Hopital Albert Michallon; Medecine Aigue Specialisee Pneumologie — La Tronche, France
- Tower Cancer Research Foundation — Beverly Hills, California, United States
Full record on ClinicalTrials.gov
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