Table 2. Ongoing Phase II Trials of Neoadjuvant Immunotherapy with or without Chemotherapy in NSCLC.
| Disease stage | N/Resected | Intervention | Primary objective | MPR (%)/pCR (%) | Surgery (%) | |
|---|---|---|---|---|---|---|
| NADIM NCT03081689 [122] | IIIA (N2 or T4) | 46/41 | Nivolumab+Paclitaxel+Carboplatin→Surgery→Nivolumab 1 year | PFS at 24 months | 83/59 | 89 |
| SKCCC-JHU NCT02259621 [111] | IB - IIIA | 22/21 | Nivolumab×2 cycles→Surgery. | Safety Feasibility | 45/15 | 95 |
| NEOSTAR NCT03158129 [108] | I - IIIA (N2 only) | 88/N: 23, N-I: 21 | Arm A: Nivolumab→Surgery. Arm B: Nivolumab, Ipilimumab→Surgery. | MPR | N: 17/9 N-I: 33/29 | N: 96 N-I: 81 |
| LCMC3 NCT02927301[110] | IB-IIIB (T3N2) | 90/77 | Atezolizumab×2 cycles→Surgery→Atezolizumab 1 year | MRP | 19/5 | 89 |
| Columbia University NCT02716038[123] | IB - IIIA | 30/11 | Atezolizumab+Carboplatin+Nab-paclitaxel→Surgery. | MPR | 57/33 | 87 |
| SAKK 16/14 NCT02572843 [124] | IIIA (T1-3 N2 M0) | 68/55 | Cisplatin+Docetaxel×3 cycles→Durvalumab×2 cycles→Surgery→Durvalumab 1 year | EFS | 60/18.2 | 81 |
MPR: Major pathologic response, pCR: Pathological complete response, PFS: Progression-free survival, N: Nivolumab, I: Ipilimumab, EFS: Event-free survival