Table 2.
Neoadjuvant studies with immunotherapy +/− chemotherapy in stage III-N2 NSCLC.
| Study | Phase | Primary Endpoint | NSCLC Stage (% Stage III) |
R0 Patients | Neo-IO | Neo-ChT | iRAE ≥ 3 | pCR Rate | MPR Rate |
|---|---|---|---|---|---|---|---|---|---|
| CheckMate-159 [47] | I | Safety | I-IIIA (33%) | 91% | Nivolumab 3 mg/kg/2 w × 2 cycles | None | 5% | 15% | 18% |
| LCMC3 [49] | II | MPR | IB-IIIB (46%) | 101 | Atezolizumab 1200 mg, D1 and D22 | None | 6% | 5% | 40.5% |
| ChiCTR-OIC-17013726 [50] | Ib | Safety | IA-IIIB (45%) | 93% | Sintilimab 200 mg q32 × 2 cycles | None | 10% | 16.2% | 24% |
| NEOSTAR [51] | II | MPR | I-IIIA-single N2 (20%) | 44 (23 N, 22 N + I) | N 3 mg/kg D1,15,29 or N + I 1 mg/kg D1 | None | NR | 15% | 25% (7 N, 4 N + I) |
| TOPT1201 [52] | II | T cells ^ | II-IIIA (75%) | 54% | Neoadjuvant Ipilimumab 10 mg/kg q3w cycles 2 and 3 + Adjuvant I q3w × 2 cycles | Paclitaxel 175 mg/m2 + cisplatin 75 mg/m2 or carboplatin AUC6 × 3 cycles | NR | 15.4% | NR |
| Shu et al. [53] | II | MPR | IB-IIIA (77%) | 87% | Atezolizumab 1200 mg, q3w × 4 cycles | Nab-paclitaxel 100 mg/m2 D1,8,15 + carboplatin AUC5 D1/21d | NR | 33.3% | 56.7% |
| NADIM [54] | II | 24-m-PFS | IIIA (100%) | 89% | Neoadjuvant N 360 mg q3w × 3 cycles + adjuvant N 1 y | Paclitaxel 200 mg/m2 + carboplatin AUC6 | NR | 59% | 83% |
^ Percentage of subjects with detectable circulating T cells after treatment. MPR = major pathological response (<10% viable tumor). pCR = pathological complete response. NS = not specified, m = months, iRAEs = immune-related adverse events, N = nivolumab; I = ipilimumab. DRAEs= drug-related adverse events; PFS = progression-free survival; w = weeks; D = day; d = days; AUC = area under curve.