Phase 2 Randomized Study of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) for Treatment of Chemotherapy Induced Neutropenia in Patients With Locally Advanced or Metastatic Non‑Small Cell Lung Cancer Receiving First-Line Chemotherapy

Inclusion Criteria:

- Histologically confirmed NSCLC

- Stage IIIb-Stage IV NSCLC

- ECOG performance status of 0-2

- Adequate liver and renal function

- Adequate bone marrow reserve

Exclusion Criteria:

- Treatment with neoadjuvant or adjuvant chemotherapy within 1 year

- Histologically confirmed mixed tumors containing small cell elements

- Treatment with radiotherapy (except limited in nature) within 3 weeks of
randomization

- History of bone marrow transplantation or stem cell support

- Known history of CNS metastasis unless the patient has had treatment with surgery or
radiotherapy, is neurologically stable and does not require oral or IV steroids or
anticonvulsants

- History of HIV

- Grade 3 or 4 peripheral neuropathy

- Weightloss greater than 5% within 6 months

- Uncontrolled pleural effusion