Table 3. Ongoing Randomized Phase III Trials of Neoadjuvant Immunotherapy With or Without Chemotherapy in NSCLC.
Eligible patients | Intervention | Estimated enrolment | The primary endpoint | |
---|---|---|---|---|
ChekMate 816 NCT02998528 | IB-IIIA | Arm A: Platinum doublet × 3 cycles → Surgery → CT ± RT Arm B: Nivolumab + Platinum doublet × 3 cycles → Surgery → CT ± RT | n=350 | DFS pCR |
IMpower030 NCT03456063 | II, IIIA, select IIIB | Arm A: Atezolizumab + Platinum doublet × 4 cycles → Surgery → Atezolizumab Arm B: Placebo + Platinum doublet × 4 cycles → Surgery → Placebo | n=302 | MPR DFS |
KEYNOTE 671 NCT03425643 | IIB-IIIA | Arm A: Pembrolizumab + Platinum doublet × 4 cycles → Surgery → Pembrolizumab. Arm B: Placebo + Platinum doublet × 4 cycles → Surgery → Placebo | n=786 | DFS OS |
ChecMate 77T NCT04025879 | II-IIIB | Arm A: CT + Nivolumab → Surgery + Nivolumab Arm B: CT + Placebo → Surgery + Placebo | n=452 | DFS |
AEGEAN NCT03800134 | IIIA-IIIB | Arm: CT + Durvalumab → Surgery Arm B: CT + Placebo → Surgery | n=300 | MPR |
CT: Chemotherapy, RT: Radiotherapy, DFS: Disease-free survival, pCR: Pathological complete response, MPR: Major pathological response, OS: Overall survival