Randomized, Multicenter, Double-blind, Phase 3 Trial of Tavocept Versus Placebo in Patients With Newly Diagnosed or Relapsed Advanced Primary Adenocarcinoma of the Lung Treated With Docetaxel or Paclitaxel Plus Cisplatin

Inclusion Criteria:

- Confirmed histopathological diagnosis of inoperable advanced primary adenocarcinoma
(including bronchioalveolar cell carcinoma) of the lung

- No prior systemic treatment for non-small cell lung cancer including chemotherapy,
immunotherapy, hormonal therapy, targeted therapies or investigational drugs

Exclusion Criteria:

- Small cell, squamous cell, large cell or undifferentiated or any form of mixed (eg,
small cell and adenocarcinoma or squamous and adenocarcinoma) histopathological or
cytological diagnosis of primary lung cancer

- Adenocarcinoma arising from primary sites other than the lung

- Patients without documented Stage 4 disease (in accordance with AJCC TMM Staging
System 7th edition)

- Patients with unstable CNS mets within 21 days before randomization