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
Trial Purpose and Description
Primary Outcome Measures:
· Overall survival
Secondary Outcome Measures:
· Progression-free survival
· Number and type of adverse events related to KD019
· Objective response rate
- 18 Years and older
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.
- Kadmon Corporation, LLC
- November 2012
- Last Updated:
- Study HIC#:
Clinicaltrials.gov ID: Yale4409252