Table 4. Characteristic of current published neoadjuvant immunochemotherapy randomized controlled trials.
| Trial | Tumor stage | Phase | Regimen | Cycle | Sample size | Surgery patients | ORR rate | MPR rate | pCR rate | Recurrence rate/survival |
|---|---|---|---|---|---|---|---|---|---|---|
| neoSCORE (36), (NCT04459611) | Stage IB-IIIA | 2 | Sintilimab + platinum-based chemotherapy × 2 cycles; Sintilimab + platinum-based chemotherapy × 3 cycles | 2 | 30 | 26 | 55.2% | 26.9% | 19.2% | – |
| 3 | 30 | 29 | 50.0% | 41.4% | 24.1% | – | ||||
| NADIM (14), (NCT03081689) | IIIA | 2 | Nivolumab + paclitaxel and carboplatin | 3 | 46 | 41 | 76% | 73.9% | 56.9% | PFS: 77.1% [24 months] |
| CheckMate-816 (17), (NCT02998528) | IB (≥4 cm) –IIIA | 3 | Nivolumab + platinum-based chemotherapy × 3 cycles | 3 | 179 | 141 | – | 36.9% | 24.0% | mEFS: 31.6 months |
| SAKK 16/14 (16), (NCT02572843) | IIIA (N2) | 2 | Durvalumab + cisplatin + docetaxel × 3 cycles | 3 | 67 | 55 | 43% | 62.0% | 18.0% | mEFS: not reached [28.6 months] |
| NADIM II (37), (NCT03838159) | IIIA, resectable IIIB | 2 | Nivo + carboplatin/paclitaxel × 3 cycles | 3 | 90 | 87 | 75.4% | 52% | 36.2% | – |
| NeoTAP01 (33), (NCT04304248) | IIIA or T3-4N2 IIIB | 2 | Toripalimab + carboplatin + pemetrexed/nab-paclitaxel × 3 cycles | 3 | 33 | 30 | 87.9% | 60.6% | 45.5% | 2 patients [10.13 months] |
| NCT03366766 (38) | IB (≥4cm)-IIIA | 2 | Nivolumab + cisplatin and + pemetrexed/gemcitabine × 3 cycles | 3 | 13 | 13 | 46.2% | 46.2% | 38.5% | 0 patients [10 months] |
| NCT03480230 (12) | IB-IIIA | 1 | Avelumab + cisplatin/carboplatin + gemcitabine/pemetrexed × 3 cycles | 3 | 15 | 11 | 26.7% | 18.1% | 9.1% | – |
| NCT02716038 (10) | IB–IIIA | 2 | Atezolizumab + carboplatin + nab-paclitaxel | 4 | 30 | 29 | 63.0% | 57.0% | 33.0% | mDFS: 17.9 months [12.9 months] |
mEFS, median event-free survival; mDFS, median disease-free survival; PFS, progression-free survival.