Table 2.
Five Major Trials Of Neoadjuvant Immunotherapy In Early-Stage And Locally Advanced NSCLC
| Study Type | Eligible Patients | Intervention | Actual Enrollment | The Primary Endpoint | ||
|---|---|---|---|---|---|---|
| CheckMate-159 | Open-label, single arm | Resectable stage I(>2cm)/II/IIIA NSCLC | Nivolumab×2 doses→Surgery | N=21 | Drug-related adverse event | 32 |
| LCMC3 | Multicenter, single arm, phase II |
Resectable Stage IB-IIIB NSCLC | Atezolizumab×2 cycles→Surgery | N=101 | MPR:19% | 36 |
| NEOSTAR | Randomized, open-label, Phase II | Resectable Stage I-IIIA(single N2) NSCLC | Arm A: nivolumab→Surgery Arm B: nivolumab+ipilimumab→ Surgery |
N=44 | MPR:24% | 37 |
| NADIM | Multicenter, open-label, single arm, phase II |
Stage IIIA(N2/T4N0) NSCLC | Nivolumab+ platinum doublet×3cycles→Surgery→nivolumab,1 year | N=46 | PFS at 24 months | 38 |
| ChiCTR-OIC-17,013,726 | Open-label, single arm, phase IB |
Resectable Stage IB-IIIA NSCLC | Sintilimab×2 cycles→Surgery | N=30 | 1. drug-related adverse event; 2. surgery complications; 3. no-delay surgery rate. | 39 |
Abbreviations: NSCLC, non-small-cell lung cancer; NCT, National Clinical Trials; MPR, Major pathological response; PFS, Progression free survival.