Table 1 Clinical characteristics and outcomes of the included randomized controlled trials
From: The landscape of immune checkpoint inhibitor therapy in advanced lung cancer
Trials | Trial phase | Line of treatment | Intervention (No.) | Control (No.) | Age, Median (Range) | Efficiency | TRAEs | |||
|---|---|---|---|---|---|---|---|---|---|---|
OS (95% CI) | PFS (95% CI) | ORR | Grade 3–5 | Grade 1–5 | ||||||
NSCLC | ||||||||||
 KEYNOTE-407, 2018 | III | 1 | PEM plus PBC (278) | PBC plus placebo (281) | Int:65 (29–87) Con:65 (36–88) | 0.64 (0.49–0.85) | 0.56 (0.45–0.70) | 161/278 108/281 | 194/278 191/280 | 273/278 274/280 |
 KEYNOTE-021, 2016 | II | 1 | PEM plus PBC (60) | PBC (63) | Int:62.5 (54–70) Con:63.2 (58–70) | 0.56 (0.32–0.95) | 0.53 (0.33–0.86) | 33/60 18/63 | 24/59 17/62 | 55/59 57/62 |
 OAK ITT850 2017, 2019 | III | > 1 | ATE (425) | DOC (425) | Int:63.5 (33–77) Con:58.5 (34–79) | 0.75 (0.64–0.88) | 0·95 (0·82–1·10) | 58/425 57/425 | 90/609 248/578 | 390/609 496/578 |
 CheckMate 026 2017 | III | 1 | NIV (271) | PBC (270) | Int:63 (32–89) Con:65 (29–87) | 1.08 (0.87–1.34) | 1.19 (0.97–1.46) | 55/211 71/212 | 47/267 133/263 | 190/267 243/263 |
 OAK ITT1225 2018 | III | > 1 | ATE (613) | DOC (612) | Int:63 (25–84) Con:64 (34–85) | 0.80 (0.70–0.92) | 0.96 (0.85–1.08) | 84/613 72/612 | 243/609 322/578 | 574/609 557/578 |
 JAVELIN Lung 200, 2018 | III | > 1 | Avelumab (396) | DOC (396) | Int:64 (58–69) Con:63 (57–69) | 0·90 (0·75–1·08) | 1·16 (0·97–1·40) | 59/396 44/396 | 39/393 180/365 | 251/393 254/365 |
 KEYNOTE-189, 2018 | III | 1 | PEM plus PBC (410) | PBC plus placebo (206) | Int:65 (34–84) Con:63 (34–84) | 0.49 (0.38–0.64) | 0.52 (0.43–0.64) | 195/410 39/206 | 272/405 133/202 | 404/405 200/202 |
 KEYNOTE-042, 2019 | III | 1 | PEM (637) | PBC (637) | Int:63 (57–69) Con:63 (57–69) | 0.81 (0.71–0.93) | 1.07 (0.94–1.21) | 174/637 169/637 | 113/636 252/615 | 399/636 553/615 |
 KEYNOTE-010, a, 2016 | II/III | > 1 | PEM (344) | DOC (172) | Int:63 (56–69) Con:62 (56–69) | 0.71 (0.58–0.88) | 0.88 (0.74–1.05) | 62/344 16/172 | 43 /339 55/155 | 215/339 126/155 |
 KEYNOTE-010, b, 2016 | II/III | > 1 | PEM (346) | DOC (171) | Int:63 (56–69) Con:62 (56–69) | 0.61 (0.49–0.75) | 0.79 (0.66–0.94) | 64/346 16/171 | 55/343 54/154 | 226/343 125/154 |
 POPLAR, 2016 | II | > 1 | ATE (144) | DOC (143) | Int:62 (42–82) Con:62 (36–84) | 0.73 (0.53–0.99) | 0.94 (0.72–1.23) | 21/144 21/143 | 57/142 71/135 | 95/142 119/135 |
 PACIFIC 2017, 2018 | III | > 1 | DUR (476) | PBC plus Placebo (237) | Int:64 (31–84) Con:64 (23–90) | 0.68 (0.47–0.997) | 0.52 (0.42–0.65) | 126/443 34/123 | 142/475 61/234 | 460/475 222/234 |
 KEYNOTE- 024, 2016, 2019 | III | 1 | PEM (154) | PBC (151) | Int:64.5 (33–90) Con:66.0 (38–85) | 0.63 (0.47–0.86) | 0.50 (0.37–0.68) | 69/154 42/151 | 48/154 80/150 | 118/154 135/150 |
 CheckMate 017 2015 | III | > 1 | NIV (135) | DOC (137) | Int:62 (39–85) Con:64 (42–84) | 0.59 (0.44–0.79) | 0.62 (0.47–0.81) | 27/135 12/137 | 9/131 71/129 | 76/131 111/129 |
 IMpower110 2020 | III | 1 | ATE (277) | PBC (277) | Int:64 (30–81) Con:65 (30–87) | 0.83 (0.65–1.07) | 0.77 (0.63–0.94) | 81/277 88/277 | 97/286 149/263 | 258/286 249/263 |
 CheckMate 057 2015 | III | > 1 | NIV (292) | DOC (290) | Int:61 (37–84) Con:64 (21–85) | 0.73 (0.59–0.89) | 0.92 (0.77–1.11) | 56/292 36/290 | 30/287 144/268 | 199/287 236/268 |
 IMpower150 2018 | III | 1 | ATE plus PBC (400) | PBC (400) | Int:63 (31–89) Con:63 (31–90) | 0.78 (0.64–0.96) | 0.61 (0.52–0.72) | 224/353 159/331 | 230/393 197/394 | 371/393 376/394 |
 CheckMate 078 2020 | III | > 1 | NIV (338) | DOC (166) | Int:60 (27 to 78) Con:60 (38 to 78) | 0.75 (0.61–0.93) | : 0.79 (0.65–0.98) | 59/338 7/166 | 41/337 74/156 | 219/337 131/156 |
 IMpower130 2019 | III | 1 | ATE plus PBC (483) | PBC (240) | Int:64 (18–86) Con:65 (38–85) | 0·80 (0·65–0·99) | 0.65 (0·54–0·77) | 220/447 72/226 | 354/473 141/232 | 455/473 215/232 |
 ARCTIC, a, 2020 | III | > 1 | DUR (62) | Erlotinib, gemcitabine, or vinorelbine) (64) | Int:63.5 (35–79) Con:62.0 (41–81) | 0.63 (0.42–0.93) | 0.71 (0.49–1.04) | 22/62 8/64 | 25/62 41/63 | 60/62 63/63 |
 ARCTIC, b 2020 | III | > 1 | DUR plus TRE (174) | Erlotinib, gemcitabine, or vinorelbine) (118) | Int:62.5 (26–81) Con:65 (42–83) | 0.80 (0.61–1.05) | 0.77 (0.59–1.01) | 26/174 8/118 | 74/173 57/110 | 160/173 105/110 |
 CameL 2020 | III | 1 | CAM plus PBC (205) | PBC (207) | Int:59 (54–64) Con:61 (53–65) | 0.73 (0.53–1.02) | 0.60 (0.45–0.79) | 124/205 80/207 | 78/205 63/207 | 146/205 132/207 |
 CheckMate 227 2019 | III | 1 | NIV plus IPI (583) | PBC (583) | Int:64 (26–87) Con:64 (29–87) | 0.73 (0.64–0.84) | 0.79 (0.69–0.91) | 199/583 162/583 | 189/576 205/570 | 442/576 467/570 |
 CheckMate 9LA 2021 | III | 1 | NIV plus IPI plus PBC (361) | PBC (358) | Int:65 (59–70) Con:65 (58–70) | 0·69 (0·55–0·80) | 0·68 (0·57–0·82) | 138/361 89/358 | 168/358 132/349 | 327/358 303/349 |
 CA184–041, a 2012 | II | 1 | Concurrent IPI plus PBC (70) | PBC (33) | Int:59 (36–82) Con:62 (36–82) | 0.99 (0.67–1.46) | 0.88 (0.61–1.27) | 15/70 6/33 | 40/71 13/32 | 52/71 23/32 |
 CA184–041, b 2012 | II | 1 | Phased IPI plus PBC (68) | PBC (33) | Int:61 (36–82) Con:62 (36–88) | 0.87 (0.59–1.28) | 0.69 (0.48–1.00) | 22/68 6/33 | 36/67 13/33 | 49/67 23/33 |
 CA184–104 2017 | III | 1 | IPI plus PBC (388) | PBC plus placebo (361) | Int:64 (28–84) Con:64 (28–85) | 0.91 (0.77–1.07) | 0.87 (0.75–1.01) | 171/388 170/361 | 205/388 129/361 | 344/388 292/361 |
 IMpower132 2020 | III | 1 | ATE plus PBC (292) | PBC (286) | Int:64 (31–85) Con:63 (33–83) | 0.86 (0.71–1.06) | 0.60 (0.49–0.72) | 137/292 92/286 | 208/291 166/274 | 287/291 266/274 |
 PEMBRO-RT 2019 | II | > 1 | PEM plus Radiotherapy (36) | Radiotherapy (40) | Int:62 (35–78) Con:62 (38–78) | 0.66 (0.37–1.18) | 0.71 (0.42–1.18) | 13/36 7/40 | 12/35 6/37 | NA |
 IMpower131 2020 | III | 1 | ATE plus PBC (343) | PBC (340) | Int:65 (23–83) Con:65 (38–86) | 0.88 (0.73–1.05) | 0.71 (0.60–0.85) | 170/343 139/340 | 231/334 195/334 | 316/334 303/334 |
 EMPOWER-Lung 1 2021 | III | 1 | CEM (283) | PBC (280) | Int:63 (58–69) Con:64 (58–70) | 0.57 (0.42–0.77) | 0.54 (0.43–0.68) | 111/283 57/280 | 50/355 134/342 | 204/355 303/342 |
 RATIONALE 307, a 2021 | III | 1 | TIS plus PBC (120) | PBC (61) | Int:60 (41–74) Con:62 (34–74) | \ | 0.52 (0.37–0.74) | 87/120 30/61 | 103/120 47/59 | 119/120 59/59 |
 RATIONALE 307, b 2021 | III | 1 | TIS plus PBC (119) | PBC (60) | Int:63 (38–74) Con:62 (34–74) | \ | 0.48 (0.34–0.68) | 89/119 30/60 | 99/118 47/58 | 117/118 58/58 |
SCLC | ||||||||||
 CASPIAN, a 2021 | III | 1 | TRE plus DUR plus PBC (268) | PBC (269) | Int:63 (58–68) Con:63 (57–68) | 0·82 (0·68–1·00) | 0·84 (0·70–1·01) | 156/267 78/134 | 196/266 86/133 | 264/266 129/133 |
 CASPIAN, b 2021 | III | 1 | DUR plus PBC (268) | PBC (269) | Int:62 (58–68) Con:63 (57–68) | 0.75 (0.62–0.91) | 0·80 (0·66–0·96) | 182/268 78/135 | 171/265 87/133 | 260/265 129/133 |
 IFCT-1603 2019 | II | > 1 | ATE (49) | PBC (24) | Int:65.9 (51.1–85.5) Con:63.5 (51.8–81.0) | 0.84 (0.45–1.58) | 2.26 (1.30–3.39) | 1/43 2/20 | 2/48 18/24 | NA |
 IMpower133 2018 | III | 1 | ATE plus PBC (201) | PBC plus placebo (202) | Int:64 (28–90) Con:64 (26–87) | 0.70 (0.54–0.91) | 0.77 (0.62–0.96) | 121/201 130/202 | 115/198 113/196 | 188/198 181/198 |
 CA184–041, a 2013 | II | 1 | Concurrent IPI plus PBC (43) | PBC plus placebo (23) | Int:57 (44–80) Con:58 (42–82) | 0.95 (0.59–1.54) | 0.93 (0.59–1.48) | 14/43 11/23 | 19/42 10/22 | 29/42 18/22 |
 CA184–041, b 2013 | II | 1 | Phased IPI plus PBC (42) | Placebo plus PBC (22) | Int:59 (43–80) Con:58 (42–82) | 0.75 (0.46–1.23) | 0.93 (0.59–1.45) | 24/42 11/22 | 22/42 9/22 | 33/42 18/22 |
 CA184–156, 2016 | III | 1 | IPI plus PBC (478) | Placebo plus PBC (476) | Int:62 (39–85) Con:63 (36–81) | 0.94 (0.81–1.09) | 0.85 (0.75–0.97) | 297/478 296/476 | 231/478 214/476 | 391/478 361/478 |
 CheckMate 331 2021 | III | > 1 | NIV (284) | PBC (285) | Int:62 (37–85) Con:61 (34–82) | 0.86 (0.72–1.04) | 1.41 (1.18–1.69) | 39/284 47/285 | 39/282 194/265 | 156/282 239/265 |