A Multi-Center, Phase 3, Double-Blind, Randomized, and Controlled Trial of KD019 vs Erlotinib in Subjects With Stage IIIB/IV Non-Small Cell Lung Cancer Who Have Progressed After First- or Second-Line Chemotherapy
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Non-Small-Cell Lung
Both
Carcinoma, Non-Small-Cell Lung
Trial Information
A Multi-Center, Phase 3, Double-Blind, Randomized, and Controlled Trial of KD019 vs Erlotinib in Subjects With Stage IIIB/IV Non-Small Cell Lung Cancer Who Have Progressed After First- or Second-Line Chemotherapy
Inclusion Criteria
For Eligibility subjects must have:
- failed one or two previous courses of therapy.
- have no active brain metastasis. Treated non-active brain metastasis are acceptable.
- cannot have received an EGFR inhibitor (Tarceva[erlotinib] or Iressa[gefitinib]) in
the past.
- has demonstrated progressive disease.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Overall survival
Outcome Time Frame:
Will be performed until documentation of progressive disease per RECIST or death due to any cause, an expected average of approximately 1year
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
KD019-301
NCT ID:
NCT01487174
Start Date:
November 2011
Completion Date:
Related Keywords:
- Carcinoma, Non-Small-Cell Lung
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Yale Cancer Center | New Haven, Connecticut 06520-8028 |
| San Juan Oncology Associates | Farmington, New Mexico 87401 |
