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
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, 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
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.
Trial registration: ClinicalTrials.gov NCT00321815.
Keywords: EGFR; PF-3512676; Toll-like receptor 9; carcinoma; epidermal growth factor; erlotinib; non-small cell lung cancer; receptor.
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Source: PubMed