Originally published as JCO Early Release 10.1200/JCO.2008.19.9331 on April 20 2009

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Phase II Study of the Anti–Insulin-Like Growth Factor Type 1 Receptor Antibody CP-751,871 in Combination With Paclitaxel and Carboplatin in Previously Untreated, Locally Advanced, or Metastatic Non–Small-Cell Lung Cancer

From The University of Texas M. D. Anderson Cancer Center, Houston, TX; University Hospital Doce de Octubre, Madrid; Institut Català d'Oncologia, L'Hospitalet, Barcelona, Spain; University of Turin, Orbassano, Turin, Italy; Mayo Clinic Foundation, Rochester, MN; Arizona Cancer Center, Tucson, AZ; West Clinic, Memphis, TN; California Cancer Care, Greenbrae, CA; Fox Chase Cancer Center, Philadelphia, PA; and Pfizer Global Research and Development, New London, CT.

Corresponding author: Antonio Gualberto, MD, PhD, Pfizer Global Research and Development, 50 Pequot Ave, MS6025-A3266, New London, CT 06320; e-mail: antonio.gualberto{at}pfizer.com.

Purpose We conducted a phase II study of combination of the anti–insulin-like growth factor 1 receptor antibody CP-751,871 with paclitaxel and carboplatin (PCI) in advanced treatment-naïve non–small-cell lung cancer (NSCLC).

Patients and Methods Patients were randomly assigned (2:1) to paclitaxel 200 mg/m², carboplatin (area under the plasma concentration-time curve of 6), and CP-751,871 10 to 20 mg/kg (PCI₁₀, PCI₂₀) or paclitaxel and carboplatin alone (PC) every 3 weeks for up to six cycles. PCI_10-20 patients could continue CP-751,871 (figitumumab) treatment after chemotherapy discontinuation. Patients treated with PC experiencing disease progression were eligible to receive CP-751,871 at investigator's discretion. An additional nonrandomized single-arm cohort of 30 patients with nonadenocarcinoma tumor histology receiving PCI₂₀ was enrolled on completion of the randomized study.

Results A total of 156 patients were enrolled onto the randomized portion of the study. Safety and efficacy information are available for 151 patients (98 patients treated with PCI and 53 patients treated with PC). Forty-eight patients treated with PCI received PCI₁₀ and 50 patients received PCI₂₀ in two sequential stages. Twenty of 53 patients treated with PC received CP-751,871 after disease progression. PCI was well tolerated. Fifty-four percent of patients treated with PCI and 42% of patients treated with PC had objective responses. Sixteen of 23 patients assessable for efficacy in the nonrandomized single-arm extension cohort also responded to treatment. Of note, 14 of 18 randomly assigned and 11 of 14 nonrandomly assigned patients treated with PCI with squamous cell carcinoma histology had response to treatment, including nine objective responses in bulky disease. Responses were also observed in two patients with squamous histology receiving CP-751,871 on PC discontinuation. PCI₂₀/PC hazard ratio for progression-free survival was 0.8 to 0.56, according to censorship.

Conclusion These data suggest that PCI₂₀ is safe and effective in patients with NSCLC.

Supported by Pfizer, Inc.

Presented in part at the 44th Annual Meeting of the American Society of Clinical Oncology, May 30-June 3, 2008, Chicago, IL; and the 33rd Congress of the European Society of Medical Oncology, September 12-16, 2008, Stockholm, Sweden.

Clinical trial information can be found for the following: NCT00147537.

Clinical Trials repository link available on JCO.org.

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