Carcinoma, Non-Small Cell Lung
Conditions
Keywords
Immunotherapy, lung cancer
Brief summary
Eligible patients will be randomized in a ratio of 2:1 to receive either chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection or chemotherapy alone. Protocol therapy will be administered until disease progression or intolerable toxicity. CpG 7909 Injection will be administered subcutaneously, on Weeks 2 and 3 of each three-week cycle (days 8 and 15) and chemotherapy will be administered on Week 1 (Day 1). Patients will undergo complete disease evaluation at the end of every other treatment cycle until disease progression.
Interventions
DRUGCPG 7909
CPG 7909 Injection will be administered subcutaneously at a starting dose of 0.20 mg/kg at the beginning of Weeks 2 and 3 of the three-week cycle.
DRUGChemotherapy
A taxane and a platinum compound given on week one of three-week cycles: Regimen A: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Cisplatin 75 mg/m2 Regimen B: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Carboplatin AUC of 6 Regimen C: Docetaxel 75 mg/m2, Cisplatin 75 mg/m2 Regimen D: Docetaxel 75 mg/m2, Carboplatin AUC of 6
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed non-small cell lung cancer that is beyond surgical cure or that is metastatic (Stage IIIB or IV according to AJCC). * Patients must have measurable disease according to the RECIST criteria.
Exclusion criteria
* Prior treatment with chemotherapy; patients may have received prior radiotherapy. * Patients with suspected or known CNS metastases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy- overall response rate (CR & PR) according to the RECIST criteria | Indeterminate |
| Safety- drug exposure, adverse events, laboratory tests, vital signs, ECG, and physical examinations | Indeterminate |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy | Indeterminate |
| compare number of patients who achieve complete response, partial response, or stable disease (CR, PR, SD) between the two treatment groups | Indeterminate |
| duration of overall response (CR, PR), survival time, and time to disease progression. | Indeterminate |
| To assess the immunopharmacodynamic response to CPG 7909 Injection plus chemotherapy in responding vs nonresponding patients receiving chemotherapy or the combination. | Indeterminate |
Countries
Canada, Germany, United States
Outcome results
None listed