Table 4.
Selected ongoing clinical trials of ErbB family inhibitors in Phase II or III development for HNSCC
| Agent | Study | Study population | Study regimen(s) | Primary endpoint(s) | Target accrual (status) |
|---|---|---|---|---|---|
| mAbs | |||||
| Cetuximab | Randomized, Phase III (NCT00956007 [formerly NCT01311063] [RTOG 0920]) | LA | Cetuximab/RT vs RT | OS | 700 (recruiting) |
| Randomized, Phase III (NCT01302834 [RTOG 1016]) | LA | Cetuximab/RT vs CRT | OS | 706 (ongoing; not recruiting) | |
| Panitumumab | Randomized, Phase III (NCT00820248 [NCIC CTG HN.6])117 | LA | Panitumumab/RT vs CRT | PFS | 320 (ongoing; not recruiting) |
| Nonrandomized, Phase II (NCT00446446 [PRISM]) | R/M | Panitumumab monotherapy | RR | 52 (ongoing; not recruiting) | |
| Nonrandomized, Phase II (NCT00798655) | LA | Panitumumab/CRT | Disease progression, change in tumor size | 46 (ongoing; not recruiting) | |
| Zalutumumab | Randomized, Phase III (NCT00496652 [DAHANCA 19]) | LA | Zalutumumab/CRT vs CRT | LR control rate | 600 (ongoing; not recruiting) |
| Nimotuzumab | Randomized, Phase III (NCT00957086) | LA | Adjuvant nimotuzumab/CRT vs adjuvant CRT | DFS | 710 (recruiting) |
| Randomized, Phase III (NCT01074021) | LA | Nimotuzumab/CRT vs placebo/CRT (in nasopharyngeal cancer) | LR control rate, safety | 480 (ongoing; not recruiting) | |
| Randomized, Phase III (NCT02012062) | LA | Neoadjuvant CT and nimotuzumab/concurrent CRT vs neoadjuvant CT and concurrent CRT (in nasopharyngeal cancer) | Safety | 320 (recruiting) | |
| Randomized, Phase II (NCT01516996) | LA | Nimotuzumab/neoadjuvant and concurrent CRT vs neoadjuvant and concurrent CRT | RR | 80 (recruiting) | |
| MEHD7945A | Randomized, Phase II (NCT01577173) | R/M | MEHD7945A vs cetuximab | PFS | 122 (ongoing; not recruiting) |
| TKIs | |||||
| Erlotinib | Nonrandomized, Phase II (NCT00720304) | LA | Erlotinib/CRT | PFS, TTP | 37 (ongoing; not recruiting) |
| Randomized, Phase II (NCT01064479) | R/M | Erlotinib/CT followed by erlotinib maintenance vs placebo/CT followed by placebo maintenance | PFS | 120 (recruiting) | |
| Afatinib | Randomized, Phase III (NCT01345669 [LUX-Head & Neck 2]) | LA | Adjuvant afatinib vs placebo after CRT | DFS | 669 (recruiting) |
| Randomized, Phase III (NCT01427478 [GORTEC 2010-02]) | LA | Afatinib maintenance after CRT vs placebo maintenance after CRT | DFS | 315 (recruiting) | |
| Randomized, Phase III (NCT01856478 [LUX-Head & Neck 3]) | R/M | Afatinib vs methotrexate | PFS | 300 (recruiting) | |
| Randomized, Phase III (NCT02131155 [LUX-Head & Neck 4]) | LA | Adjuvant afatinib vs placebo after CRT | DFS | 150 (recruiting) | |
| Randomized, Phase II (NCT01415674 [PREDICTOR]) | LA | Neoadjuvant afatinib vs placebo | Biomarkers | 60 (ongoing; not recruiting) | |
| Lapatinib | Randomized, Phase II (NCT01711658 [TRYHARD]) | LA | Lapatinib/CRT vs CRT | PFS | 176 (recruiting) |
Abbreviations: HNSCC, head and neck squamous cell carcinoma; mAb, monoclonal antibody; LA, locally advanced; RT, radiation therapy; OS, overall survival; CRT, chemoradiation therapy; PFS, progression-free survival; R/M, recurrent or metastatic; CT, chemotherapy; RR, response rate; LR, locoregional; DFS, disease-free survival; TKI, tyrosine kinase inhibitor; TTP, time to progression.