Table 3. Ongoing trials of neoadjuvant therapy for NSCLC.
| Treatment | NCT | Regimen | Primary endpoint | Stage | N | Estimated completion date | Phase |
|---|---|---|---|---|---|---|---|
| Neoadjuvant ICI monotherapy | NCT04047186 | Nivolumab + S | MPR | Multi-GGO | 50 | 2024/12 | 2 |
| NCT03732664 | Nivolumab/Pembrolizumab + S | Feasibility and safety | High-risk resectable NSCLC | 40 | 2027/10 | 1 | |
| NCT02818920 TOP1501 | Pembrolizumab + S + Pembrolizumab | Feasibility and safety | Ib–IIIa | 30 | 2026/3 | 2 | |
| NCT02938624 MK3475-223 | Pembrolizumab + S | Feasibility and safety | I–II | 28 | 2021/4 | 1 | |
| NCT03197467 NEOMUN | Pembrolizumab + S | Feasibility and safety | II–IIIa | 30 | 2023/10 | 2 | |
| NCT02994576 PRINCEPS | Atezolizumab + S | Feasibility and safety | Ib–IIIa | 60 | 2022/12 | 2 | |
| NCT03030131 IONESCO | Durvalumab + S | Surgical resection | Ib–IIIb | 81 | 2019/8 | 2 | |
| NCT04371796 | Sintilimab + S | MPR | II–IIIa | 20 | 2021/12 | 2 | |
| NCT04197076 | ICl ×2 + S | DFS, pCR | IIIa | 200 | 2021/5 | NA | |
| NCT03853187 DONAN | Durvalumab + S + RT/CT | Feasibility and safety | III | 20 | 2022/4 | 2 | |
| Neoadjuvant ICI combine with chemotherapy | NCT04541251 TOP-LC1210 | (Camrelizumab + CT) ×3 | MPR | Ib–IIIa | 40 | 2023/9 | 2 |
| NCT 04144608 | (Toripalimab + CT) + S | Surgical resection | IIIa or IIIb | 30 | 2020/12 | 2 | |
| NC TO4304248 NeoTPD01 | (Toripalimab + CT) ×3 | pCR | III | 30 | 2026/7 | 2 | |
| NCT04586465 DYNAPET | (Pembrolizumab + CT) ×3 | MPR, SUV | IIa–IIIb | 23 | 2022/6 | 2 | |
| NCT04379739 | Camrelizumab + CT; Camrelizumab + Apatinib | MPR | II–IIIa | 82 | 2026/12 | 2 | |
| NCT04865705 | Tislelizumab + CT | R0 | III | 33 | 2021/12 | 2 | |
| Neoadjuvant and adjuvant ICI | NCT04512430 | (Atezolizumab + Bevacizumab + CT) + S + (Atezolizumab q4w ×6 mon) |
MPR | IIIa (EGFR+) | 26 | 2026/8 | 2 |
| NCT04465968 DEEP _OCEAN | (Durvalumab + RT + CT) + S + (Durvalumab/RT + CT) |
3 yr OS | III | 84 | 2030/8 | 3 | |
| NCT04326153 | Sintilimab + CT) + S + (Sintilimab ×8 + CT ×2) | 2 yr DFS | IIIa | 40 | 2022/12 | 2 | |
| NCT03838159 NADIMII | (Nivolumab + CT) ×3 + S + (Nivolumab ×1 y) | pCR | III | 90 | 2027/9 | 2 | |
| NCT04379635 RATIONALE 315 | (Tislelizumab 200 mg Q3W + CT) ×3 + S + (Tislelizumab 400 mg Q6W) ×8 |
MPR, EFS | II–IIIA | 380 | 2021/2 | 3 | |
| RCT | NCT02998528 CheckMate816 | (Nivolumab + CT) + S; S + CT | EFS, pCR | Ib–IIIa | 350 | 2028/11 | 3 |
| (Nivolumab + Ipilimumab) + S | |||||||
| NCT03425643 KEYNOTE-671 | (Pembrolizumab + CT) ×4 + S + (Pembrolizumab ×13); NAC + S |
EFS, OS | II–IIIb (T3-4N2) | 786 | 2026/6 | 3 | |
| NCT03456063 IMpower030 | (Atezolizumab + CT) + S + (Atezolizumab ×16); NAC + S |
MPR, EFS | II–IIIb | 450 | 2024/11 | 3 | |
| NCT03800134 AEGEAN | (Durvalumab + CT) + S; NAC + S |
MPR, EFS | II–III | 800 | 2024/1 | 3 | |
| NCT04025879 | (Nivolumab + CT) + S + (Nivolumab); NAC + S |
EFS | IIa (>4 cm)–IIIb (T3N2) | 452 | 2024/9 | 3 | |
| NCT04338620 | Camrelizumab + CT) + S; NAC + S | pCR | III (N2) | 94 | 2021/11 | 2 | |
| NCT04379635 | (Tislelizumab + CT) + S + (Tislelizumab); NAC + S |
MPR, EFS | II–IIIa | 380 | 2025/11 | 3 | |
| NCT04422392 | (ICI + CT) + S + (ICI + CT); NAC + S + CT |
MPR | IIIa (N2) | 90 | 2025/6 | 2 | |
| NCT04061590 | Pembrolizumab + S; (Pembrolizumab + CT) + S |
TIL | I–IIIa | 84 | 2022/4 | 2 | |
| NCT04459611 neoSCORE | (Sintilimab + CT) ×2 + S + (CT ×2 + Sintilimab ×1 y); (Sintilimab + CT) ×3 + S + (CT ×1 + Sintilimab ×1 y) |
MPR | Ib–IIIa | 60 | 2023/7 | 2 | |
| NCT03916627 | Cemiplimab + S + (Cemiplimab + CT); (Cemiplimab + CT) + S + (Cemiplimab + CT); NAC + S + (Cemiplimab + CT) |
MPR | NSCLC | 94 | 2027/8 | 2 | |
| Neoadjuvant ICI + RT | NCT02904954 | Durvalumab + S + Durvalumab ×1 y; (Durvalumab ×3 + RT) + S + (Durvalumab ×1 y) |
MPR | Ib–IIIa | 60 | 2022/4 | 2 |
| NCT03217071 PembroX | Pembrolizumab + S; (Pembrolizumab + RT) + S | TIL | I–IIIa | 40 | 2021/12 | 2 | |
| NCT03237377 | (Durvalumab + RT) + S; (Durvalumab + Tremelimumab + RT) + S |
Feasibility and safety | IIIa | 32 | 2021/9 | 2 | |
| NCT04245514 SAKK 16/18 | Durvalumab ×1 + CT ×3 + RT) + S + (Durvalumab ×13 q4w) |
EFS | T1-4 (>7 cm) N2 | 90 | 2025/3 | 2 |
NSCLC, non-small cell lung cancer; MPR, main pathological response; pCR, pathological complete response; SUV, standardized uptake value; ICI, immune checkpoint inhibitor; S, surgery; RT, radiotherapy; CT, chemotherapy; NAC, neoadjuvant chemotherapy; OS, overall survival; EFS, event-free survival; TIL, tumor infiltrating lymphocyte; RCT, randomized controlled trial; GGO, ground-glass opacity; DFS, disease-free survival.