Status:
COMPLETED
Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in Stage III Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
Sanofi
Genentech, Inc.
Conditions:
Carcinoma, Non-Small-Cell Lung
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a national, randomized, web-based, double-blind study to determine whether erlotinib (Tarceva) compared to placebo improves progression-free survival (PFS) for patients with inoperable, stage ...
Detailed Description
The promising activity of erlotinib as a single agent in advanced refractory NSCLC along with its oral administration and favorable adverse event profile makes this agent an excellent candidate to inc...
Eligibility Criteria
Inclusion
- Unresectable, stage IIIA or IIIB NSCLC (measurable disease is not required)
- No evidence of metastatic disease
- No prior treatment
- Adequate organ function
- Adequate pulmonary function (FEV \>= 1.0L or predicted FEV \>0.8L)
Exclusion
- Metastasis
- Prior treatment
- Malignant pleural or pericardial effusion
- Peripheral neuropathy \>= grade 2
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT00153803
Start Date
May 1 2005
End Date
April 1 2014
Last Update
September 6 2019
Active Locations (65)
Enter a location and click search to find clinical trials sorted by distance.
1
Birmingham Hematology and Oncology Associates, LLC
Birmingham, Alabama, United States, 35235
2
Oncology Specialties, P.C.
Huntsville, Alabama, United States, 35801
3
Cooper Clinic
Fort Smith, Arkansas, United States, 72913
4
Genesis Cancer Center
Hot Springs, Arkansas, United States, 71913