Table 1. Early results of clinical trials on major neoadjuvant immunotherapy.
| Clinical trials | Phase | No. (n) | Stage | Neo-adjuvant immunotherapy | Adjuvant treatment after surgery | Timing of surgery (weeks) | Primary endpoint | Treatment-related surgical delays/cancel (%) | AEs | References |
| NSCLC, non-small cell lung cancer; MPR, major pathologic response; RFS, recurrent-free survival; pCR, pathological complete response; EFS, event-free survival; ORR, objective response rate; PD, progressive disease; AE, adverse event; irAE, immune-related AE; ALT, alanine aminotransferase concentration; AST, aspartate aminotransferase concentration. | ||||||||||
| CA209-159 (NCT02259621) | Ib | 22 | I−IIIA resectable NSCLC | Nivolumab, 3 mg/kg;
Q2W, 2 cycles |
− | 4 | MPR, 45%; 18 months RFS, 73% | − | 1 case of long-term irAE (skin, grade 3) | (14,15) |
| ChIctr-OIC-
17013726 |
Ib | 22 | IA−IIIB resectable NSCLC | Sintilimab; 200 mg;
Q3W, 2 cycles |
− | 4 | MPR, 45.5% pCR, 18.2% | − | − | (16) |
| LCMC3 (NCT02927301) | II | 101 | IB−IIIB (T3N2) resectable NSCLC | Atezolizumab, 1,200 mg;
Q3W, 2 cycles |
− | 6 | MPR, 19% pCR, 5% | One case of delayed operation (grade 3 pneumonia) | 2 cases of grade 5 AE, grade 3 and above AE 6% (6/101) | (17,18) |
| NADIM (NCT03081689) | II | 46 | IIIA (N2) resectable NSCLC | Nivolumab, 360 mg, +
carboplatin + paclitaxel; Q3W, 3 cycles |
Nivolumab 240 mg Q2W for 4 months and 480 mg Q4W for 8 months | 9 | MPR, 85.36% pCR, 71.4% | − | 1 case of grade 4 AE, grade 3 and above AE 8.8% (4/46) | (19) |
| SAKK 16/14 (NCT 02572843) | II | 68 | IIIA (N2) resectable NSCLC | Cisplatin, 100 mg/m2 + docetaxel 85 mg/m2; Q3W, 3 cycles, followed by durvalumab 750 mg; Q2W, 2 cycles | Durvalumab 750 mg Q2W, for 12 months | 13 | 1-year EFS rate, 73.3%, ORR, 44.8% after neoadjuvant chemotherapy and 59.7% after additional neoadjuvant immunotherapy | 4 cases not undergoing surgery due to PD | - | (20,21) |
| NEOSTAR (NCT03158129) | II | 44 | I−IIIA (N2) resectable NSCLC | Nivolumab (3 mg/kg, d 1, 15,29) ± ipilimumab (1 mg/kg, d1) 3 cycles | − | 3−6 | MPR, 17%/33% | − | Grade 3 and above AE: 24% (N: 16%, NI: 8%) | (22) |
| NCT02716038 | II | 30 | IIIA | Atezolizumab, 1,200 mg + nab-paclitaxel + carboplatin; Q3W, 4 cycles | − | 12 | MPR, 57% | − | Grade 3 and above AE: neutropenia 50% (15/30), increases ALT 7% (2/30), increases AST 7% (2/30), Thrombocytopenia 7% (2/30) | (23) |