Table 1.
Characteristics of clinical studies included in the single‐arm meta‐analysis
| Study | Region | Patients | Age (years) | Male (%) | Quit | Phase | Tumor histology | Drug | Clinical setting | Combined with | Study design | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2012 | Topalian et al. 16 | North America | 76 | NR | NR | NR | I | Squamous (n = 18) | Nivolumab 1 mg/kg (n = 18) | Q2W, IV total 12 cycles | NR | Noncomparative open‐label cohort study |
| Nonsquamous (n = 56) | Nivolumab 3 mg/kg (n = 19) | Q2W, IV total 12 cycles | ||||||||||
| Unknown (n = 2) | Nivolumab 10 mg/kg (n = 39) | Q2W, IV total 12 cycles | ||||||||||
| 2013 | Rizvi et al. 17 | North America | 43 | NR | NR | 3 | I | Squamous (n = 15) | Nivolumab 10 mg/kg (n = 12)a | Q3W, IV | Gemcitabine, cisplatin, pemetrexed, carboplatin, paclitaxelc | Noncomparative open‐label cohort study |
| Nonsquamous (n = 28) | Nivolumab 10 mg/kg (n = 15) | Q3W, IVb | ||||||||||
| Nivolumab 10 mg/kg (n = 16) | Q3W, IV | |||||||||||
| 2014 | Antonia et al. 18 | North America | 49 | NR | NR | 18 | I | Squamous (n = 18) | Nivolumab 1 mg/kg (n = 24) | Q3W, IV for 4 cycles followed by nivolumab 3 mg/kg, Q2W, IV | Ipilimumabd | Noncomparative open‐label cohort study |
| Nonsquamous (n = 31) | Nivolumab 3 mg/kg (n = 25) | Q3W, IV for 4 cycles followed by nivolumab 3 mg/kg, Q2W, IV | ||||||||||
| 2014 | Antonia et al. 19 | North America | 46 | NR | NR | 16 | I | Squamous (n = 15) | Nivolumab 1 mg/kg (n = 22) | Q3W, IV for 4 cycles followed by nivolumab 3 mg/kg, Q2W, IV | Ipilimumab | Noncomparative open‐label cohort study |
| Nonsquamous (n = 31) | Nivolumab 3 mg/kg (n = 24) | Q3W, IV for 4 cycles followed by nivolumab 3 mg/kg, Q2W, IV | ||||||||||
| 2014 | Ramalingam et al. 20 | North America | 117 | 65 (37–87)e | 73 | 11 | II | Squamous (n = 117) | Nivolumab 3 mg/kg (n = 117) | Q2W, IV | NR | Noncomparative open‐label cohort study |
| 2014 | Rizvi et al. 21 | North America | 33 | NR | NR | NR | I | Squamous (n = 13) | Nivolumab 5 mg/kg (n = 12) | Q3W, IV | Bevacizumaba (BEV) | Noncomparative open‐label cohort study |
| Nonsquamous (n = 20) | Nivolumab 3 mg/kg (n = 21) | Q3W, IV | ||||||||||
| 2015 | Bauer et al. 22 | North America | 226 | 67 (33–91) | 55 | 47 | I | Squamous (n = 59) | Nivolumab 3 mg/kg (n = 226) | Q2W, IV | NR | Noncomparative open‐label cohort study |
| Nonsquamous (n = 167) | ||||||||||||
| 2015 | Borghaei et al. 23 | North America | 292 | 61 (37–84) | 52 | 15 | III | Nonsquamous (n = 582) | Nivolumab 3 mg/kg (n = 292) | Q2W, IV | NR | Randomised open‐label study |
| 290 | 64 (21–85) | 58 | 44 | Docetaxel 75 mg/m2 (n = 290) | Q3W, IV | |||||||
| 2015 | Brahmer et al. 24 | North America | 135 | 62 (39–85) | 82 | 4 | III | Squamous (n = 272) | Nivolumab 3 mg/kg (n = 135) | Q2W, IV | NR | Randomised open‐label study |
| 137 | 64 (42–84) | 71 | 14 | Docetaxel 75 mg/m2 (n = 137) | Q3W, IV | |||||||
| 2015 | Gettinger et al. 25 | North America | 129 | 65 (38–85) | 79 | 18 | I | Squamous (n = 54) | Nivolumab 1 mg/kg (n = 33) | Q2W, IV for 12 cycles | NR | Noncomparative open‐label cohort study |
| Nonsquamous (n = 74) | Nivolumab 3 mg/kg (n = 37) | Q2W, IV for 12 cycles | ||||||||||
| Unknown (n = 1) | Nivolumab 10 mg/kg (n = 59) | Q2W, IV for 12 cycles | ||||||||||
| 2015 | Nishio et al. 26 | North America | 111 | NR | NR | NR | II | Squamous (n = 35) | Nivolumab 3 mg/kg (n = 111) | Q2W, IV | NR | Noncomparative open‐label cohort study |
| Nonsquamous (n = 76) | ||||||||||||
| 2015 | Rizvi et al. 27 | North America | 117 | 65 (57–61) | 85 | 14 | II | Squamous (n = 117) | Nivolumab 3 mg/kg (n = 117) | Q2W, IV | NR | Noncomparative open‐label cohort study |
| 2016 | Bidoli et al. 28 | Europe | 372 | NR | NR | NR | III | Squamous (n = 372) | Nivolumab 3 mg/kg (n = 372) | Q2W, IV for 12 cycles | NR | Noncomparative open‐label cohort study |
| 2016 | Brustugun et al. 29 | Europe | 58 | 64.6 (32–88) | 48 | 4 | III | Squamous (n = 24) | Nivolumab 3 mg/kg (n = 58) | IV | NR | Noncomparative open‐label cohort study |
| Nonsquamous (n = 34) | ||||||||||||
| 2016 | Crino et al. 30 | Europe | 371 | NR | 22 | NR | III | Squamous (n = 371) | Nivolumab 3 mg/kg (n = 371) | Q2W, IV for 12 cycles | NR | Noncomparative open‐label cohort study |
| 2016 | Gettinger et al. 31 | North America | 52 | 67 (43–85) | 50 | 6 | I | Squamous (n = 13)) | Nivolumab 3 mg/kg (n = 52) | Q2W, IV | NR | Noncomparative open‐label cohort study |
| Nonsquamous (n = 39) | ||||||||||||
| 2016 | Rizvi et al. 32 | North America | 56 | 64 (34–83) | 46 | 12 | I | Squamous (n = 16) | Nivolumab 10 mg/kga (n = 12) | Q3W, IV for 4 cycles | Gemcitabine, cisplatin, pemetrexed, paclitaxel, carboplatin | Noncomparative open‐label cohort study |
| Nonsquamous (n = 37) | Nivolumab 10 mg/kg (n = 15) | Q3W, IV for 4 cycles | ||||||||||
| Unknown (n = 3) | Nivolumab 10 mg/kg (n = 15) | Q3W, IV for 4 cycles | ||||||||||
| Nivolumab 10 mg/kg (n = 14) | Q3W, IV for 4 cycles | |||||||||||
| 2017 | Hellmann et al. 33 | North America | 77 | NR | 10 | 10 | I | Squamous (n = 13) | Nivolumab 3 mg/kgf (n = 38) | Q2W, IV | Ipilimumab | Noncomparative open‐label cohort study |
| Nonsquamous (n = 64) | Nivolumab 3 mg/kg (n = 39) | Q2W, IV | ||||||||||
| 2016 | Nisho et al. 34 | North America | 76 | 64 (39–78) | 65 | 12 | II | Nonsquamous (n = 76) | Nivolumab 3 mg/kg (n = 76) | Q2W, IV | NR | Noncomparative open‐label cohort study |
| 2017 | Carbone et al. 35 | North America | 270 | 63 (32–89) | 68 | 27 | III | Squamous (n = 129) | Nivolumab 3 mg/kg (n = 270) | Q2W, IV for 6 cycles | NR | Randomised open‐label study |
| 271 | 65 (29–87) | 55 | 35 | Nonsquamous (n = 412) | Platinum‐based (n = 271)c | Q3W, IV for 6 cycles | ||||||
Q2W, every 2 weeks; Q3W, every 3 weeks; IV, intravenous.
a
The same dosage and duration of nivolumab with different types of platinum‐based doublet chemotherapy.
b
Complete response or progressive disease or unacceptable toxicity or achieved total medication cycles are all the endpoints.
c
Platinum‐based doublet chemotherapy (gemcitabine, cisplatin, pemetrexed, carboplatin, and paclitaxel).
d
Ipilimumab is a recombinant, fully human, monoclonal antibody targeted at cytotoxic T‐lymphocyte‐associated antigen 4 (CTLA‐4) that is available for the treatment of advanced melanoma.
e
Median age (range).
f
The same dosage and duration of nivolumab with different types of ipilimumab.