Conditions: NSCLC
Keywords: Imprime PGG NSCLC Cetuximab
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 90
Healthy volunteers: no

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:

Arms:
arm 1: Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin arm 2: Cetuximab + Paclitaxel/Carboplatin

Interventions: intervention 1: Imprime PGG Injection intervention 2: Cetuximab intervention 3: Paclitaxel intervention 4: Carboplatin
Intervention descriptions: intervention 1: 4 mg/kg i.v. over 2 hrs, weekly, in three week cycles intervention 2: 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 intervention 3: 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 intervention 4: 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

Protocol document: