CPG 7909 Injection in Non-Small Cell Lung Cancer

Pfizer116 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

116

Conditions

Carcinoma, Non-Small Cell Lung

Interventions

CPG 7909DRUG

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.

ChemotherapyDRUG

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

ChemotherapyDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (24)

Office of Ronald Yanagihara

Gilroy, California, United States

Outcomes

Primary Outcomes

Efficacy- overall response rate (CR & PR) according to the RECIST criteria

Time frame: Indeterminate

Safety- drug exposure, adverse events, laboratory tests, vital signs, ECG, and physical examinations

Time frame: Indeterminate

Secondary Outcomes

Secondary Efficacy

Time frame: Indeterminate

compare number of patients who achieve complete response, partial response, or stable disease (CR, PR, SD) between the two treatment groups

Time frame: Indeterminate

duration of overall response (CR, PR), survival time, and time to disease progression.

Time frame: Indeterminate

To assess the immunopharmacodynamic response to CPG 7909 Injection plus chemotherapy in responding vs nonresponding patients receiving chemotherapy or the combination.

Time frame: Indeterminate

Data from ClinicalTrials.gov

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