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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small Cell Lung

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Indeterminate

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

C017

NCT ID:

NCT00070629

Start Date:

May 2003

Completion Date:

July 2007

Related Keywords:

  • Carcinoma, Non-Small Cell Lung
  • Immunotherapy
  • lung cancer
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
Marshfield Clinic Marshfield, Wisconsin  54449
University of Minnesota Minneapolis, Minnesota  55455
Providence Portland Medical Center Portland, Oregon  97213-3635
VA New Jersey Health Care System East Orange, New Jersey  07018
Kentucky Cancer Clinic Pikeville, Kentucky  41501
Office of Ronald Yanagihara Gilroy, California  95020
Kenmar Research Institute, LLC Los Angeles, California  90057
Comprehensive Cancer Center of the Dessert Palm Springs, California  92262
Florida Cancer Specialist Fort Myers, Florida  33901
Indiana Hematology and Oncology Associates Indianapolis, Indiana  46202
Medical Center Vincennes Vincennes, Indiana  47591
Southeast Nebraska Hematology Oncology Consultants, PC Lincoln, Nebraska  68516
HemOnCare Brooklyn, New York  11212
Cancer Care of Western North Carolina Asheville, North Carolina  28801
Cancer Care Institute of Carolina Aiken, South Carolina  29801
Charleston Hematology/Oncology, PA Charleston, South Carolina  29403
The Family Cancer Center Collierville, Tennessee  38017