Study TLK199.2102 was terminated for lack of enrollment.

TLK199.2102 was a multicenter Phase 2 randomized study to determine the effect of Telintra treatment on chemotherapy induced neutropenia (CIN) in patients with non small cell lung cancer receiving first-line therapy with carboplatin and docetaxel.

TLK199.2102 was a multicenter Phase 2 randomized study to determine the effect of Telintra treatment on chemotherapy induced neutropenia (CIN) in patients with non small cell lung cancer receiving first-line therapy with carboplatin and docetaxel.

After randomization, patients in Treatment Arm 1, chemotherapy with carboplatin and docetaxel will be administered on Day 1 of each cycle, followed by Telintra at a starting dose of 3000 mg total daily dose (1500 mg orally, twice daily) on Day 2 until the absolute neutrophil count improves as confirmed by two consecutive measurement at least 24 hours apart. In Treatment Arm 2 (control arm), chemotherapy alone consisting of carboplatin and docetaxel will be administered on Day 1 of each cycle.

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