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Promuneā„¢ (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

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Trial Information

Promuneā„¢ (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 ClinicMarshfield, Wisconsin  54449
University of MinnesotaMinneapolis, Minnesota  55455
Providence Portland Medical CenterPortland, Oregon  97213-3635
VA New Jersey Health Care SystemEast Orange, New Jersey  07018
Kentucky Cancer ClinicPikeville, Kentucky  41501
Office of Ronald YanagiharaGilroy, California  95020
Kenmar Research Institute, LLCLos Angeles, California  90057
Comprehensive Cancer Center of the DessertPalm Springs, California  92262
Florida Cancer SpecialistFort Myers, Florida  33901
Indiana Hematology and Oncology AssociatesIndianapolis, Indiana  46202
Medical Center VincennesVincennes, Indiana  47591
Southeast Nebraska Hematology Oncology Consultants, PCLincoln, Nebraska  68516
HemOnCareBrooklyn, New York  11212
Cancer Care of Western North CarolinaAsheville, North Carolina  28801
Cancer Care Institute of CarolinaAiken, South Carolina  29801
Charleston Hematology/Oncology, PACharleston, South Carolina  29403
The Family Cancer CenterCollierville, Tennessee  38017