Phase 2 trial of erlotinib with or without PF-3512676 (CPG 7909, a Toll-like receptor 9 agonist) in patients with advanced recurrent EGFR-positive non-small cell lung cancer.

Abstract

This phase 2 study assessed PF-3512676 plus erlotinib in patients with epidermal growth factor receptor-positive advanced non-small cell lung cancer after prior chemotherapy failure. Patients were randomized 1:1 to PF-3512676 (0.20 mg/kg injected subcutaneously once weekly) plus erlotinib (150 mg daily) or erlotinib alone. The primary objective was to estimate progression-free survival (PFS). Patients received PF-3512676 plus erlotinib (n = 18) or erlotinib alone (n = 21). The study was halted because an unplanned interim analysis indicated that large improvement in PFS with addition of PF-3512676 would be unlikely. In the PF-3512676-plus-erlotinib and erlotinib-alone arms, median PFS was 1.6 and 1.7 mo (hazard ratio, 1.00; 95% confidence interval, 0.5-2.0; P = 0.9335), respectively. Salient grade ≥ 3 adverse events in PF-3512676-plus-erlotinib and erlotinib-alone arms were diarrhea (5/0), dyspnea (5/6), fatigue (4/1), other flu-like symptoms (2/0), anemia (2/1), and lymphocytopenia (based on laboratory values, 1/4). Adding PF-3512676 to erlotinib did not show potential for increased progression-free survival over erlotinib alone in patients with advanced recurrent epidermal growth factor receptor-positive non-small cell lung cancer.

• Authors: Chandra P Belani, John J Nemunaitis, Abraham Chachoua, Peter D Eisenberg, Luiz E Raez, J Daniel Cuevas, Cecile B Mather, Rebecca J Benner, Sandra J Meech
• Journal: Cancer biology & therapy (Cancer Biol Ther) Vol. 14 Issue 7 Pg. 557-63 (Jul 2013) ISSN: 1555-8576 [Electronic] United States
• PMID: 23792641 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Oligodeoxyribonucleotides
• ProMune
• Protein Kinase Inhibitors
• Quinazolines
• TLR9 protein, human
• Toll-Like Receptor 9
• Erlotinib Hydrochloride
• ErbB Receptors

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Carcinoma, Non-Small-Cell Lung (drug therapy, mortality, pathology)
• Disease-Free Survival
• ErbB Receptors (biosynthesis)
• Erlotinib Hydrochloride
• Female
• Humans
• Lung Neoplasms (drug therapy, mortality, pathology)
• Male
• Middle Aged
• Oligodeoxyribonucleotides (administration & dosage)
• Protein Kinase Inhibitors (administration & dosage, adverse effects, therapeutic use)
• Quinazolines (administration & dosage, adverse effects, therapeutic use)
• Toll-Like Receptor 9 (agonists)