Study | Size | Age | Male (%) | Reported outcomes | Interventional arm | Control arm |
---|---|---|---|---|---|---|
First-line (n = 5) | ||||||
 Checkmate648 | 321/325/324 | 64/63/64 | 79/83/85 | OS; PFS; ORR; Grade ≥ 3 AEs | Nivolumab 240 mg every 2 weeks plus chemotherapy (PF) | chemotherapy alone (Fluorouracil: 800 mg mg/m2 on days 1–5 plus cisplatin: 80 mg/m2 on days 1 for every 4 weeks) |
 |  |  | OS; ORR; Grade ≥ 3 AEs | Nivolumab (3 mg per kilogram every 2 weeks) plus Ipilimumab (1 mg per kilogram every 6 weeks) | ||
 ESCORT-1st | 298/298 | 62/62 | 87/88 | OS; PFS; Grade ≥ 3 AEs | Camrelizumab 200 mg every 3 weeks plus chemotherapy (TP) | Placebo plus chemotherapy (Paclitaxel: 175 mg/m2 plus cisplatin: 75 mg/m2 on day 1 for every 3 weeks) |
 KEYNOTE 590 | 274/274 | 64/62 | 82/85 | OS; PFS; ORR; Grade ≥ 3 AEs | Pembrolizumab 200 mg every 3 weeks plus chemotherapy (PF) | Placebo plus chemotherapy (Fluorouracil: 800 mg/m2 on days 1–5 plus cisplatin: 80 mg/m2 on day 1 for every 3 weeks) |
 JUPITER-06 | 257/257 | 63/62 | 84/86 | OS; PFS; ORR; Grade ≥ 3 AEs | Toripalimab 240 mg every 3 weeks plus chemotherapy (TP) | Placebo plus chemotherapy (Paclitaxel: 175 mg/m2 plus cisplatin: 75 mg/m2 on day 1 for every 3 weeks) |
 ORIENT-15 | 327/322 | / | / | OS; PFS; ORR; Grade ≥ 3 AEs | Sintilimab 200 mg every 3 weeks plus chemotherapy (TP or PF) | Placebo plus chemotherapy (Paclitaxel: 87.5 mg/m2 on day 1, 8 or 175 mg/m2 on day 1 plus cisplatin:75 mg/m2 on day 1; or fluorouracil: 800 mg/m2 on days 1–5 plus cisplatin:75 mg/m2 on day 1) |
Second-line (n = 5) | ||||||
 ATTRACTION-3 | 210/209 | 64/67 | 85/89 | OS; PFS; ORR; Grade ≥ 3 AEs | Nivolumab 240 mg given every 2 weeks. | Investigator’s choice of chemotherapy (Paclitaxel 100 mg/m2 per week or docetaxel 75 mg/m2 every 3 weeks) |
 ESCORT | 228/220 | 60/60 | 91/87 | OS; PFS; ORR; Grade ≥ 3 AEs | Camrelizumab 200 mg given every 2 weeks. | Investigator’s choice of chemotherapy (Docetaxel 75 mg/m2 every 3 weeks or irinotecan180 mg/m2 every 2 weeks) |
 KEYNOTE-181 | 314/314 | 63/62 | 86.9/86.3 | OS; PFS; ORR; Grade ≥ 3 AEs | Pembrolizumab 200 mg given every 3 weeks. | Investigator’s choice of chemotherapy (Paclitaxel 80–100 mg/m2 every 4 weeks, docetaxel 75 mg/m2 every 3 weeks or irinotecan 180 mg/m2 every 2 weeks) |
 RATIONALE 302 | 256/256 | 62/63 | 84.8/84.0 | OS; ORR; Grade ≥ 3 AEs | Tislelzumab 200 mg given every 3 weeks. | Investigator’s choice of chemotherapy (Paclitaxel 135–175 mg /m2 every 3 weeks, docetaxel 75 mg/m2 every 3 weeks or irinotecan 125 mg/m2 every 3 weeks |
 ORIENT-2 | 95/95 | 59/59 | 92.6/88.4 | OS; PFS; ORR; Grade ≥ 3 AEs | Sintilimab 200 mg given every 3 weeks. | Investigator’s choice of chemotherapy (Paclitaxel 175 mg/m2 every 3 weeks or irinotecan 180 mg/ m2 every 2 weeks) |