A phase II study of cetuximab (C225) in combination with chemoradiation (CRT) in patients (PTS) with stage IIIA/B non-small cell lung cancer (NSCLC): A report of the 2 year and median survival (MS) for the RTOG 0324 trial

7516 Background: C225 is a chimerized monoclonal antibody that targets the epidermal growth factor receptor (EGFR). NSCLC commonly expresses the EGFR, which is associated with aggressive tumor behavior and poor clinical outcome. Preclinical model systems demonstrate radiosensitization following molecular inhibition of EGFR signaling. Methods: We report a phase II trial testing the combination of C225 with CRT in unresectable stage III NSCLC with a planned sample size of 84 PTS. Eligibility criteria included Zubrod performance status (PS) ≤ 1, weight loss ≤ 5% over past 3 months, FEV1 ≥ 1.2 L, adequate hematologic, hepatic, and renal function. PTS received an initial dose of C225 (400 mg/m2) on day 1 of wk 1, then wkly doses of C225 (250 mg/m2) until completion of therapy (wks 2 - 17). During wk 2, PTS started CRT (63 Gy/35 fractions) with wkly carboplatin (C) AUC 2 and paclitaxel (P) 45 mg/m2 x 6 doses followed by C (AUC 6) and P (200 mg/m2) x 2 cycles (wks 12–17). Interim monitoring for severe (grade ≥ 3...