TABLE 2.
Ongoing clinical trials of neoadjuvant therapy with ICIs for earlier-stage NSCLC.
| Clinical trial | Phase | Stage | Intervention used | Estimated sample size | Primary endpoints |
| MK3475-223 (NCT02938624) | I | I–II | Pembrolizumab | 28 | Toxicity, MPR |
| TOP 1501 (NCT02818920) | II | IB–IIIA | Pembrolizumab | 32 | Surgical feasibility |
| IONESCO (NCT03030131) | II | IB-II | Durvalumab | 81 | R0 resection |
| Columbia University (NCT02716038) | II | IB–IIIA | Atezolizumab | 30 | MPR |
| PRICNEPS (NCT0299457) | II | IB–IIIA | Atezolizumab | 60 | Toxicity |
| NCT02927301 | II | IB–IIIA | Atezolizumab | 180 | MPR |
| NeoCOAST | II | I–IIIA | Durvalumab ± oleclumab (MEDI9447) or monalizumab (IPH2201) or danvatirsen | 160 | – |
| SAKK 16/14 (NCT02572843) | II | IIIA (N2) | Durvalumab + chemotherapy | 68 | EFS |
| NADIM-II (NCT03838159) | II | IIIA/IIIB with T3N2 | Chemotherapy + nivolumab vs. chemotherapy | 90 | pCR |
| IMPower030 (NCT03456063) | III | II–IIIB | Chemotherapy + atezolizumab vs. chemotherapy + placebo | 374 | MPR, EFS |
| CheckMate 816 (NCT02998528) | III | IB–IIIA | Chemotherapy vs. chemotherapy + nivolumab vs. nivolumab + ipilimumab | 350 | EFS, pCR |
| Keynote-671 (NCT03425643) | III | II–IIIB | Chemotherapy + pembrolizumab vs. chemotherapy | 786 | EFS, OS |
| AEGEAN (NCT03800134) | III | IIA–IIIB | Chemotherapy + durvalumab vs. chemotherapy + placebo | 300 | MPR |
| NCT03110978 | I/II | I–IIA | Radiotherapy + nivolumab vs. radiotherapy | 140 | EFS, secondary malignancy, and death |
| NCT03237377 | II | IIIA | Durvalumab + radiation or durvalumab + tremelimumab + radiation | 32 | Safety, feasibility |
| NCT02904954 | III | II–III | Durvalumab with or without radiotherapy | - | DFS |
NSCLC, non-small cell lung cancer; MPR, major pathologic response; pCR, pathologic complete response; ICIs, immune checkpoint inhibitors; EFS, event-free survival; OS, overall survival; DFS, disease-free survival.