NCT00874848

Efficacy/Safety of Imprime PGG With Cetuximab & Paclitaxel/Carboplatin Therapy in Pts With Untreated Advanced Non-Small Cell Lung Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: HiberCell, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NSCLC

Interventions

Type	Name	Description
BIOLOGICAL	Imprime PGG Injection	4 mg/kg i.v. over 2 hrs, weekly, in three week cycles
BIOLOGICAL	Cetuximab	initial loading dose of 400 mg/m\^2 over 120 min and subsequent doses at 250 mg/m\^2 over 60 min, weekly on Days 1, 8 and 15 of each 3-week treatment cycle
DRUG	Paclitaxel	200 mg/m\^2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
DRUG	Carboplatin	dose equal to an 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

Timeline

• Start date: 2009-08-01
• Primary completion: 2012-11-01
• Completion: 2015-08-01
• First posted: 2009-04-03
• Last updated: 2016-11-29
• Results posted: 2016-11-29

Locations

14 sites across 2 countries: United States, Germany