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AMG 479 + Chemo in Advanced Squamous NSCLC

NCT00807612Phase 2

Key facts

Status: Terminated
Start: Jan 2009
Primary completion: Aug 2010
Countries: 1
Sponsor: ImmunityBio, Inc.
Modality: Monoclonal Antibodies

Drugs: ganitumab
Conditions: squamous cell carcinoma of the lung (SCCL)

Overview

Phase 2, open-label trial of ganitumab in squamous cell carcinoma of the lung (SCCL) (3 arms), sponsored by ImmunityBio, Inc. Primary endpoints: Dose Limiting Toxicities at 21 days and Objective Response Rate at 16 months. Started Jan 2009; status: terminated.

Design

3 arms

Study design: Non-randomizedOpen-label

Part 1 Cohort 1
AMG 479 (18 mg/kg) + Paclitaxel + Carboplatin followed by AMG 479 maintenance
Part 1 Cohort 2
AMG 479 (12 mg/kg) + Paclitaxel + Carboplatin followed by AMG 479 maintenance
Part 2
AMG 479 (Final Dose) + Paclitaxel + Carboplatin followed by AMG 479 maintenance

Endpoints

Primary

Dose Limiting Toxicities21 days
Objective Response Rate16 months

Secondary

Adverse Eventsup to 5 months
Anti-Drug Antibodies16 months
Progression Free Survival16 months
Time to Progression16 months
Duration of Response16 months

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