CPG 7909 Injection in Non-Small Cell Lung Cancer - Tabular View

Tracking Information
First Received Date ^ICMJE	October 6, 2003
Last Updated Date	February 9, 2009
Start Date ^ICMJE	May 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: February 9, 2009)	Efficacy- overall response rate (CR & PR) according to the RECIST criteria [ Time Frame: Indeterminate ] [ Designated as safety issue: No ] Safety- drug exposure, adverse events, laboratory tests, vital signs, ECG, and physical examinations [ Time Frame: Indeterminate ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: October 14, 2005)	Efficacy- overall response rate (CR & PR) according to the RECIST criteria Safety- drug exposure, adverse events, laboratory tests, vital signs, ECG, and physical examinations
Change History	Complete list of historical versions of study NCT00070629 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 9, 2009)	Secondary Efficacy [ Time Frame: Indeterminate ] [ Designated as safety issue: No ] compare number of patients who achieve complete response, partial response, or stable disease (CR, PR, SD) between the two treatment groups [ Time Frame: Indeterminate ] [ Designated as safety issue: No ] duration of overall response (CR, PR), survival time, and time to disease progression. [ Time Frame: Indeterminate ] [ Designated as safety issue: No ] To assess the immunopharmacodynamic response to CPG 7909 Injection plus chemotherapy in responding vs nonresponding patients receiving chemotherapy or the combination. [ Time Frame: Indeterminate ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: October 14, 2005)	Secondary Efficacy - compare number of patients who achieve complete response, partial response, or stable disease (CR, PR, SD) between the two treatment groups - duration of overall response (CR, PR), survival time, and time to disease progression. - Karnofsky performance status (KPS)

Descriptive Information
Brief Title ^ICMJE	CPG 7909 Injection in Non-Small Cell Lung Cancer
Official Title ^ICMJE	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
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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Carcinoma, Non-Small Cell Lung
Intervention ^ICMJE	Drug: CPG 7909 Drug: Chemotherapy
Study Arms / Comparison Groups	Experimental: Chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection Active Comparator: Chemotherapy (a taxane and a platinum compound)
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	116
Completion Date	July 2007
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada, Germany

Administrative Information
NCT ID ^ICMJE	NCT00070629
Responsible Party	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study ID Numbers ^ICMJE	C017, ProMune, CO17, A8501017
Study Sponsor ^ICMJE	Pfizer
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Pfizer
Verification Date	February 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP