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

Phase 2 Completed 90 enrolled HiberCell, Inc.

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2009-08
Primary completion: 2012-11
Completion: 2015-08

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Imprime PGG Arm vs Control Arm; p = 0.2895; Fisher Exact NCT00874848 ↗

Publications

Thomas M, Sadjadian P, Kollmeier J, Lowe J, Mattson P, Trout JR, Gargano M, Patchen ML, Walsh R, Beliveau M, Marier JF, Bose N, Gorden K, Schneller F 3rd. A randomized, open-label, multicenter, phase II study evaluating the efficacy and safety of BTH1677 (1,3-1,6 beta glucan; Imprime PGG) in combination with cetuximab and chemotherapy in patients with advanced non-small cell lung cancer. Invest New Drugs. 2017 Jun;35(3):345-358. doi: 10.1007/s10637-017-0450-3. Epub 2017 Mar 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Imprime PGG	Other / unclassified	4 mg/kg	Intravenous
Background	Carboplatin	Small molecule	6 unknown	Intravenous
Background	Cetuximab	Monoclonal antibody	250 mg/m2	—
Background	Paclitaxel	Small molecule	200 mg/m2	Intravenous