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. 2025 Jul 24;86:103369. doi: 10.1016/j.eclinm.2025.103369

Table 1.

Characteristics of included studies for vaccine therapy in advanced NSCLC patients after first-line therapy.

Study Country Phase Tumor stage Sample, n Male, n (%) Age, y First-line therapy Intervention (sample, n) Control (sample, n) Extracted endpoint Registration
Alfonso 201415 Cuba II/III IIIB/IV 176 118 (67%) Chemo/Chemoradio Racotumomab-alum (87) Placebo (89) OS, PFS, AEs RPCEC00000009
Besse 202316 France III Advanced/Metastatic 219 155 (70.8%) 65 (41–86) Chemo/ICB OSE2101 (139) SoC (80) OS, AEs NCT02654587
Butts 201117 Canada IIb IIIB/IV 171 95 (55.6%) 59 Chemo/Chemoradio BLP25 + BSC (88) BSC (83) OS
Butts 201418,a Canada III III 1239 846 (68.3%) 61 (19–89) Chemoradio BLP25 (829) Placebo (410) OS, AEs NCT00409188
Giaccone 201519 USA III IIIA/IIIB/IV 532 307 (58%) 61 ± 8.5 Chemo/Chemoradio Belagenpumatucel-L (270) Placebo (262) OS, PFS, AEs NCT00676507
Gridelli 202020 Italy II IV 190 132 (69.5%) Chemo Vx-001 (89) Placebo (101) OS NCT01935154
Katakami 201721 Japan II III 172 145 (84.3%) 63 (33–86) Chemoradio BLP25 (114) Placebo (58) OS, PFS, AEs
Mitchell 201522,a Australia III III 1239 846 (68.3%) 61 (19–89) Chemoradio BLP25 (829) Placebo (410) OS NCT00409188
Rodriguez 201623 Cuba III IIIB/IV 378 Chemo CIMAvax-EGF (246) BSC (132) OS, AEs RPCEC00000161
Takayama 201624 Japan II IIIB/IV/Recurrent 50 41 (82%) Chemo/Radio PPV vaccine + Docetaxel (26) Placebo + Docetaxel (24) OS, PFS, AEs UMIN000003521
Vinageras 200825 Cuba II IIIB/IV 74 Chemo CIMAvax-EGF (37) BSC (37) OS, AEs

Chemo: Chemotherapy; Chemoradio: Chemoradiotherapy; Radio: Radiotherapy; ICB: Immune checkpoint blockers; BSC: Best supportive care; SoC: Standard of care; OS: Overall survival; PFS: Progression-free survival; AEs: Adverse events.

a

Studies reported from the same RCT, Mitchell 2015 updated the survival data.