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. 2022 Jun 15;12(6):2447–2464.

Table 3.

Summary of clinical trials about anti-CTLA-4 in ES-SCLC

Trial Phase No. of Patients Treatment FDA Approval OS PFS ORR (%) AEs (%)
CheckMate 451 III 834 Nivolumab plus Ipilimumab vs. Nivolumab vs. placebo No 9.2 months vs. 9.6 months (HR, 0.92; 95% CI: 0.75-1.12; P=0.37) 1.7 months (1.5-2.6) vs. 1.9 months (1.6-2.6) vs. 1.4 months (1.4-1.5) 9.1 vs. 11.5 vs. 4.2 Grade 3/4 AEs 52.2 vs. 11.5 vs. 8.4
CASPIAN trial III 537 Durvalumab + Tremelimumab + chemotherapy vs. chemotherapy Yes 10.4 months vs. 10.5 months (HR, 0.81; 95% CI, 0.67-0.97; P=0.02) 16.9% (95% CI: 12.6-21.7) vs. 5.3% (95% CI: 2.9-8.8) 58 vs. 58 Serious AEs 47.4 vs. 36.5
CA184-156 III 1132 Ipilimumab + chemotherapy vs. chemotherapy No 11 months vs. 10.9 months (HR 0.94; 95% CI: 0.81-1.09; P=0.3775) 4.6 months vs. 4.4 months (HR 0.85; 95% CI: 0.75-0.97; P=0.0161) 62 vs. 62 Grade 3/4 AEs 48 vs. 45
CheckMate-032 I/II 243 Nivolumab vs. Nivolumab + Ipilimumab No 5.7 months (3.8-7.6) vs. 4.7 months (3.1-8.3) 1.4 months (1.3-1.4) vs. 1.5 months (1.4-2.2) 11.6 vs. 21.9 Grade 3/4 AEs 12.9 vs. 37.5

OS: overall survival; PFS: progression-free survival; ORR: objective responserate; AEs: adverse events.