Table 1.
Trial | N | Agent | Control arm | Timing | Duration | Primary end point | Significant toxicity related to drug | Delay in surgery |
---|---|---|---|---|---|---|---|---|
Baumen | 55 |
|
Yes | Neoadj | 7–21 days | Biomarker | No | NR |
Schmitz | 33 | Cetuximab | Yes | Neoadj | 21 days | Safety | No | No |
Gross | 47 |
|
Yes | Neoadj | 7–14 days | Biomarker | No | NR |
MachieLs | 30 | Afatinib | Yes | Neoadj | 14 days | FDG-PET response | 1 patient with G3 diarrhea and ARF | 3 patients |
Curry | 39 | Metformin | No | Neoadj | 9–24 days | Biomarker | No | NR |
Thomas | 35 | ErLotinib | No | Neoadj | 8–29 days | Biomarker | 6 patients discontinued because of G3 pruritis and G2 rash | No |
Campo | 107 | Lapatinib | Yes | Prior to CRT | 2–6 weeks | Biomarker | No | NA |
Berinstein | 27 | IRX-2 | No | Neoadj | 10 days | Biomarker Safety | 1 post-op wound complication possibly reLated | No |
Ferris | 29 | NivoLumab | No | Neoadj | 29 days | Safety | No | No |
UppaLuri | 21 | PembroLizumab | No | Neoadj | 14–21 days | LRR | No | No |
BeLL | 17 | MEDI6469 | No | Neoadj | 8–14 days | Safety | No | No |
Shayan | 14 | Cetuximab pLus motoLimod | No | Neoadj | 21–28 days | Biomarker | No | No |
LRR locoregional recurrence
Neoadj neoadjuvant prior to surgical resection