A single-arm, open-label, phase 2 study of nab-paclitaxel and carboplatin chemotherapy plus necitumumab in the first-line treatment of patients with stage IV squamous non-small cell lung cancer (NSCLC)

Background

Necitumumab (neci), a human IgG1-type monoclonal antibody directed against the EGFR has recently been found to significantly improve outcomes in patients with Stage IV squamous NSCLC when combined with gemcitabine/cisplatin. These data coupled with the efficacy and safety advantages of nab-paclitaxel (nab-pac) over solvent-based paclitaxel provide a strong rationale for the investigation of neci in combination with nab-pac as first-line therapy in Stage IV squamous NSCLC.

Trial design

JFCP (NCT02392507) is a single-arm, open-label, Phase 2 study being conducted to evaluate the effectiveness and safety and tolerability of nab-pac and carboplatin plus neci as first-line therapy in patients with Stage IV squamous NSCLC (life expectancy ≥12 weeks; ECOG PS ≤1; tumor tissue availability for immunohistochemistry analysis). Study therapy consists of an induction (triplet) regimen of nab-pac (100 mg/m² IV on Days 1, 8, and 15) and carboplatin (AUC 6 mg.min/mL IV on Day 1) plus neci (800 mg absolute dose IV on Days 1 and 8) administered for a maximum of 4 cycles (or until radiographic documentation of progressive disease, toxicity requiring cessation, protocol noncompliance, or withdrawal of consent). Patients with a response of stable disease or better, assessed radiographically, after 4 cycles of induction regimen are eligible to receive the maintenance (doublet) regimen of neci (800 mg on Days 1and 8) plus nab-pac (100 mg/m² on Days 1 and 8) every 3 weeks until disease progression occurs or other discontinuation criteria are met. The primary endpoint of this study is the best objective response rate (ORR); key secondary endpoints include PFS, OS, and DCR. Efficacy analyses for ORR and DCR will be performed for qualified patients (received any amount of study drug and had a complete radiographic assessment at baseline). Patients surviving for ≥8 weeks after first dose and with no post-baseline radiographic assessment will be disqualified. Efficacy analyses for PFS and OS will be performed for all patients who have received any amount of study drug. Enrollment began October 2015; planned enrollment is 50 patients.

Clinical trial identification

ClinicalTrails.gov identifier: NCT02392507

Legal entity responsible for the study

Eli Lilly and Company

Funding

Eli Lilly and Company

Disclosure

M. Socinski: Research Support: Lilly and Celgene Speaker's Bureau: Celgene. M. Gil, J. Shahidi, G.Y. Chao: Employee of Eli Lilly and Company. All other authors have declared no conflicts of interest.