Although concurrent chemoradiotherapy is the standard therapy for unresectable stage III non–small cell lung cancer (NSCLC), no optimal concurrent chemoradiotherapy regimen has been identified in non–squa-mous NSCLC. We conducted an open–label, multicenter phase I trial to assess the safety of carboplatin (CBDCA) plus pemetrexed (PEM) with concurrent thoracic radiotherapy (TRT) of 60 Gy. The primary endpoint was determi-nation of the maximum tolerated dose. In total, 6 patients were registered during the period from February 2012 through January 2014. Dose–limiting toxicities (DLTs) were observed in 2 patients (one case each of prolonged neutropenia and pneumonitis). The overall response rate was 83.3%, and median progression–free survival was 20.1 months. Since only two DLTs were observed in the phase I cohort, we concluded that CBDCA plus PEM with concurrent TRT was feasible in Japanese patients with unresectable stage III non–squamous NSCLCs. We will rec-ommend the dose of CBDCA area under the curve 5 plus PEM 500 mg/m2 for the next phase II trial.
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