Efficacy/Safety of Imprime PGG® Injection With Bevacizumab and Paclitaxel/Carboplatin in Patients With Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)

PHASE2CompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

June 30, 2009

Primary Completion Date

April 30, 2016

Study Completion Date

May 31, 2016

Conditions
Non-Small Cell Lung Cancer
Interventions
BIOLOGICAL

Imprime PGG® Injection

4 mg/kg, i.v. over 2 hr, weekly until progression or discontinuation

BIOLOGICAL

Bevacizumab

15 mg/kg, i.v., over 90 minutes, on Day 1 only of each 3-week treatment cycle

DRUG

Paclitaxel

200 mg/m2, i.v. over 3 hr, on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles.

DRUG

Carboplatin

AUC of 6 mg./mL · min based on the Calvert formula; i.v. over 30 min, on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles

Trial Locations (10)

44718

Gabrail Cancer Center, Canton

72703

Highlands Oncology Group, Fayetteville

78229

University of Texas Health Science Center, San Antonio, San Antonio

89081

Universitätsklinikum Ulm, Ulm

Unknown

Kliniken der Stadt Köln gGmbH, Cologne

Hospital Marth-Maria Halle Dolau, Halle

Clinical Kassel GmbH, Kassel

University of Mainz, Mainz

University of Munich, Munich

Pius-Hospital Oldenburg, Oldenburg

Sponsors

Lead Sponsor

All Listed Sponsors
lead

HiberCell, Inc.

INDUSTRY

NCT00874107 - Efficacy/Safety of Imprime PGG® Injection With Bevacizumab and Paclitaxel/Carboplatin in Patients With Untreated Advanced Non-Small Cell Lung Cancer (NSCLC) | Biotech Hunter | Biotech Hunter