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. 2019 May;11(5):2117–2125. doi: 10.21037/jtd.2019.05.34

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.