Study | Population | Ph | N | PE | Treatment | Key results |
Neoadjuvant immunotherapy monotherapy vs dual immunotherapy | ||||||
CANOPY-N NCT03968419 | Stage IB-IIIA | II | 88 | MPR | Canakinumab vs pembrolizumab vs combined | Canakinumab: MPR 2.9% Pembrolizumab: MPR 11.1% Combined: MPR 17.1% |
NeoCOAST NCT03794544 | Stage I-IIIA | II | 84 | MPR | Durvalumab vs durvalumab+oleclumab vs durvalumab+monalizumab vs durvalumab+danvatirsen | Durvalumab: MPR 11.1% Oleclumab: MPR 19.0% Monalizumab: MPR 30.0% Danvatirsen: MPR 31.3% |
NEOSTAR NCT03158129 | Stage I-IIIA | II | 44 | MPR | Nivolumab vs nivolumab+ipilimumab | Nivolumab: MPR 22% Nivo+ipilimumab: MPR 38% |
Neoadjuvant chemotherapy vs chemoimmunotherapy | ||||||
TD-FOREKNOW NCT04338620 | Stage IIIA-IIIB | II | 88 | pCR | CT+camrelizumab vs CT | CT+camrelizumab: pCR 32.6% CT: pCR 8.9% |
CheckMate 816 NCT02998528 | Stage IB-IIIA | III | 358 | EFS, pCR | CT+nivolumab vs CT | CT+nivolumab: pCR 24.0%, MPR 36.9% CT: pCR 2.2%, MPR 8.9% |
NADIM II NCT03838159 | Stage IIIA-IIIB | II | 86 | pCR | CT+nivolumab vs CT | CT+nivolumab: pCR 37% CT: pCR 7% |
AEGEAN NCT03800134 | Stage II-IIIB | III | 740 | EFS, pCR | CT+durvalumab vs CT | Durvalumab: pCR 17.2%, MPR 33.3% CT: pCR 4.3%, MPR 12.3% |
CheckMate 77T NCT04025879 | Stage II-IIIB | III | 461 | EFS | CT+nivolumab vs CT | Nivolumab: pCR 25.3%, MPR 35.4% CT: pCR 4.7%, MPR 12.1% |
KEYNOTE-671 NCT03425643 | Stage II-IIIB | III | 797 | EFS, OS | CT+pembrolizumab vs CT | Pembrolizumab: pCR 18.1%, MPR 30.2% CT: pCR 4.0%, MPR 11.0% |
Neotorch NCT04158440 | Stage II-III | III | 404 | EFS, MPR | CT+toripalimab vs CT | Toripalimab: MPR 48.5%, pCR 24.8% CT: MPR 8.4%, pCR 1.0% |
RATIONALE-315 NCT04379635 | Stage II-IIIA | III | 453 | EFS, MPR | CT+tislelizumab vs CT | Tislelizumab: MPR 56.2%, pCR 40.7% CT: MPR 15.0%, pCR 5.7% |
Neoadjuvant chemoradiotherapy | ||||||
Albain et al PMID19632716 | Stage IIIA(N2) | III | 396 | OS | CT/RT/S vs CT/RT | pCR: 18% |
Epithor PMID37156211 | T3-4 tumors | RS | 688 | OS | S vs CT+S vs CT/RT/S | CRT: pCR: 18.5% CT: pCR: 6% |
ESPATUE PMID26527789 | Stage IIIA-B | III | 246 | OS | CT/RT/S vs CT/RT | pCR 33% |
Cerfolio et al PMID19233668 | Stage III | RS | 216 | DES | CT/RT/S | pCR 33% |
CT, chemotherapy; DES, descriptive endpoints; EFS, event-free survival; MPR, major pathological response; OS, overall survival; pCR, pathological complete response; PE, primary endpoints; Ph, phase; RS, retrospective study; RT, radiotherapy; S, surgery.