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Completed

NCT Number: NCT00070629

CPG 7909 Injection in Non-Small Cell Lung Cancer

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.

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Key information

Conditions

Carcinoma, Non-small Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Queen Elizabeth II Health, Halifax, Nova Scotia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CPG 7909

Drug

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.

Other names: ProMune, PF-3512676

Chemotherapy

Drug

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

Primary outcomes

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

    Time frame: Indeterminate

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

    Time frame: Indeterminate

Secondary outcomes

  1. Secondary Efficacy

    Time frame: Indeterminate

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

    Time frame: Indeterminate

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

    Time frame: Indeterminate

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

    Time frame: Indeterminate

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2007
First posted
Oct 8, 2003
Registry last updated
Feb 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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