Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
Non-small cell lung cancer
Brief summary
The purpose of this trial is to study the efficacy and safety of the triplet combination of TLK286, carboplatin and paclitaxel as first-line therapy for patients with advanced non-small cell lung cancer.
Interventions
DRUGTLK286
Every 3 Weeks with a starting dose of TLK286 @ 400 mg/m²
DRUGcarboplatin
AUC 6 mg/mL/min Once every 3 weeks
DRUGpaclitaxel
200 mg/m² Once every 3 weeks
Sponsors
Telik
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Histologically confirmed non-small cell lung cancer (NSCLC) * Stage IV or IIIB (disease that is not eligible for combined modality chemotherapy and radiation) * Measurable disease by RECIST * ECOG status of 0-1 * Adequate liver and renal function * Adequate bone marrow reserves
Exclusion criteria
* Prior chemotherapy, immunotherapy or biologic therapy for metastatic NSCLC * Up to one prior adjuvant or neoadjuvant chemotherapy is allowed * History of bone marrow transplantation or stem cell support * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study Objectives | Every 6 Weeks | 1. To determine the MTD of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin 2. To determine the safety of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin 3. To determine the objective response rate (ORR) of patients treated with the triplet combination of TLK286, paclitaxel and carboplatin |
Countries
United States
Outcome results
None listed