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Brief Title: Efficacy/Safety of Imprime PGG With Cetuximab & Paclitaxel/Carboplatin Therapy in Pts With Untreated Advanced Non-Small Cell Lung Cancer
Official Title: Efficacy and Safety Study of Imprime PGG® Injection in Combination With Cetuximab and Concomitant Paclitaxel and Carboplatin Therapy in Patients With Previously Untreated Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer
Study ID: NCT00874848
Brief Summary: The Phase 2 study described in this protocol will serve to evaluate the antitumor activity, safety and pharmacokinetic profile of Imprime PGG when combined with cetuximab and concomitant paclitaxel and carboplatin therapy in patients with previously untreated advanced NSCLC. Additionally, this study will provide guidance for the design of more definitive efficacy studies of Imprime PGG in NSCLC patients.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Medical College of Georgia, Augusta, Georgia, United States
Providence Medical Group, Terre Haute, Indiana, United States
University of Minnesota, Minneapolis, Minnesota, United States
Mary Crowley Medical Research Center, Dallas, Texas, United States
Allison Cancer Center, Midland, Texas, United States
Helios Clinic Emil von Behring, Berlin, , Germany
Municipal Clinic Frankfurt Hoescht, Frankfurt, , Germany
Georg-August University Gottingen, Gottingen, , Germany
University Clinical Heidelberg, Heidelberg, , Germany
Clinic Minden, Minden, , Germany
Techincal University of Munich, Munich, , Germany
Clinic Nurnberg Nord, Nuremberg, , Germany
Universitätsklinikum Ulm, Ulm, , Germany
HELIOS Klinikum Wuppertal, Medizinische Klinik 1, Wuppertal, , Germany
Name: Folker Schneller, MD
Affiliation: Technical University, Munich
Role: PRINCIPAL_INVESTIGATOR