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Brief Title: Efficacy/Safety of Imprime PGG® Injection With Bevacizumab and Paclitaxel/Carboplatin in Patients With Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)
Official Title: A Phase 2, Randomized, Efficacy and Safety Study of Imprime PGG® Injection in Combination With Bevacizumab and Concomitant Paclitaxel and Carboplatin Therapy in Patients With Previously Untreated Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer
Study ID: NCT00874107
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 bevacizumab 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
Highlands Oncology Group, Fayetteville, Arkansas, United States
Gabrail Cancer Center, Canton, Ohio, United States
University of Texas Health Science Center, San Antonio, San Antonio, Texas, United States
Hospital Marth-Maria Halle Dolau, Halle/Saale, , Germany
Clinical Kassel GmbH, Kassel, , Germany
Kliniken der Stadt Köln gGmbH, Köln, , Germany
University of Mainz, Mainz, , Germany
University of Munich, Munich, , Germany
Pius-Hospital Oldenburg, Oldenburg, , Germany
Universitätsklinikum Ulm, Ulm, , Germany
Name: Folker Schneller, MD
Affiliation: Klinikum rechts der Isar der Technischen Universitaet Muenchen
Role: PRINCIPAL_INVESTIGATOR