CPG 7909 Injection in Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Promune™ (CPG 7909 Injection) In Combination With Chemotherapy In Patients With Advanced Or Metastatic Non-Small Cell Lung Cancer, A Randomized, Multi-Center, Controlled, Phase 2 Study

Conditions
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Carcinoma, Non-Small Cell Lung

Intervention / Treatment
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* Drug: CPG 7909
* Drug: Chemotherapy
* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection | Drug: CPG 7909<br>* 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.<br>* Other names: ProMune, PF-3512676;Drug: Chemotherapy<br>* 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<br>* Other names: Paclitaxel (Taxol), docetaxel (TAXOTERE) cisplatin and carboplatin (e.g. PARAPLATIN);|
| Active Comparator: 2<br>Chemotherapy (a taxane and a platinum compound) | Drug: Chemotherapy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunotherapy, lung cancer