Table 3.
Clinical trials of neoadjuvant combination immunotherapy for resectable NSCLC
| Identifier | Trials | Phase | Population | EGFR/ALK alternation exclusiveness | Sample size (N) | Intervention | Primary endpoint | Study group outcomes | Control group outcomes | ≥grade 3 irAE | Resection rate | Surgical delay rate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03081689 24 | NADIM | 2 | IIIA | Yes | 46 | Nivolumab 360 mg + paclitaxel and carboplatin q3w × 2—surgery—nivolumab 1 year | PFS at 24 months | 89% R0 resection24 m PFS rate 77.1% MPR 83%pCR 63% | Single arm | NA | 87% | 0 |
| NCT03158129 33 | NEOSTAR | 2 | I‐IIIA | No | 44 | Nivolumab 3 mg/kg q2w × 3 ± ipilimumab 1 mg/kg × 1—surgery—SOC adjuvant therapy | MPR | MPR 22%, pCR 9% | MPR 38%, pCR 29% | 13% | 89% | 22% |
| NCT03366766 37 | / | 2 | IB (≥4 cm)‐IIIA | Yes | 13 | Nivolumab 360 mg + Pemetrexed/Gemcitabine + cisplatin q3w × 3—surgery | MPR | MPR 46%pCR 38% | Single arm | NA | NA | NA |
| NCT02572843 38 | SAKK 16/14 | 2 | IIIA (N2 only) | No | 67 | Cisplatin/docetaxel × 3—durvalumab 750 mg × 2—surgery—durvalumab 1 year | EFS at 1 year | 1‐year EFS 73%. MPR 62%pCR 18% | Single arm | 88% | 82% | NA |
| NCT02716038 39 | / | 2 | IB‐IIIA | No | 30 | Atezolizumab 1200 mg + nab‐paclitaxel + carboplatin × 4—surgery | MPR | MPR 57% | Single arm | NA | 87% | 0 |
Abbreviations: EFS, event‐free survival; MPR, major pathological response; NA, data are not available; pCR, pathological complete response; PFS, progression‐free survival.