Status:
TERMINATED
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).
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Non-Squamous Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 10 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2010
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT00760929
Start Date
November 10 2008
End Date
June 25 2010
Last Update
January 5 2021
Active Locations (57)
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1
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211
2
Florida Cancer Inst.
New Port Richey, Florida, United States, 34655
3
Emory Univ Winship Cancer Inst
Atlanta, Georgia, United States, 30322
4
University of Chicago Medical Center; Dept. of Medicine/Section of Nephrology
Chicago, Illinois, United States, 60637