5041 Background: Anthracyclines and platinum derivates are active drugs for pts with AEC, but new schedules with higher efficacy and better tolerability are needed. A prospective phase 2 study was conducted to describe tolerability and activity of C + PLD in pts with AEC. Methods: Pts with chemo-naïve AEC, PS ≤2, aged less than 75 years and with at least one measurable lesion were eligible. Treatment was C (AUC 5) + PLD (40 mg/m2) on day 1 every 4 weeks, up to 6 cycles. A single-stage design was applied. With objective response as primary endpoint, type I error = 0.05 and II error = 0.10, p0 = 0.20, p1= 0.40, 42 patients were needed, with at least 13 objective responses to define the treatment active. Response was assessed by RECIST and toxicity was coded with NCI-CTC. Results: From November 2002 to July 2005, 42 pts were enrolled at 5 Institutions. Median age was 64 years (31–74). PS was 0/1/2 in 28/13/1 pts, respectively. 62% of pts were stage IV. Out of 40 pts out of treatment, 3 complete (7.5%) and 20 partial responses (50%) have been already observed, for an overall response rate of 57.5% (95% exact CI: 40.9–73.0). One death potentially related to treatment was recorded (death at home for unknown reasons after 6th cycle). Other relevant toxicities (% of pts) were g3/4 neutropenia 30%/15%, febrile neutropenia 5%, g3/4 thrombocytopenia pts 17.5%/5%, g3/4 anemia 32.5%/5%, g3 heart rhythm 1 pt, g2 liver toxicity 1pt. Skin toxicity was mild: g1 12.5%, g2 7.5%, g3 5%. Hair loss: complete 1 pt, partial 12.5%. Conclusions: The combination of C and PLD shows a good activity and a favourable toxicity profile in first-line chemotherapy of pts with AEC, deserving further studies in this setting. No significant financial relationships to disclose.
CheckMate 592: A phase II exploratory study of biomarkers associated with the efficacy of first-line nivolumab (nivo) plus ipilimumab (ipi) in patients (pts) with stage IV or recurrent NSCLC