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

Non Small Cell Lung Cancer

Primary Outcome Measures:

· Overall survival

Secondary Outcome Measures:

· Progression-free survival

· Number and type of adverse events related to KD019

· Objective response rate

Participation Guidelines

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.

Clinicaltrials.gov ID: Yale4409252