Table 3. Key completed studies of immunotherapy in early stage NSCLC.
Reference (trial) | Phase | Stage | A/NA | Other key selection criteria | Agent | No. of participants | Primary endpoint | Key results |
---|---|---|---|---|---|---|---|---|
Yi 2017 (TOP1201)** | II | IB–IIIA | NA | – | Ipilimumab ×2 cycles, with platinum doublet chemotherapy ×3 cycles | 24 | % of subjects with detectable circulating T cells after treatment | Increased activation of CD4/CD8 T cells with ipilimumab, though primary endpoint not met |
Yang 2018 (TOP1201)** | II | II–IIA | NA | – | Ipilimumab ×2 cycles, with platinum doublet chemotherapy ×3 cycles | 13 | Surgical outcomes | 90-day mortality (1% and 0%) in preoperative chemotherapy alone versus ipilimumab groups, respectively. No increase in adverse surgical outcomes (P values not reported) |
Forde 2018 (NA_00092076)** | II | I–IIA | NA | – | Nivolumab ×2 cycles | 21 | Safety | Few side effects, no treatment-related delays in surgery, and major pathological response in 45% of resected tumors |
**, indicates single-arm study. NSCLC, non-small cell lung cancer.