CPG 7909 Injection in Non-Small Cell Lung Cancer

Pfizer

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Non-Small Cell Lung

Treatments: Drug: CPG 7909; Drug: Chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00070629

A8501017

CO17

ProMune

C017

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

1

Experimental group

Description:

Chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection

Treatment:

Drug: Chemotherapy

Drug: Chemotherapy

Drug: CPG 7909

2

Active Comparator group

Description:

Chemotherapy (a taxane and a platinum compound)

Treatment:

Drug: Chemotherapy

Drug: Chemotherapy