Drugs / Cetuximab
Cetuximab
DrugCetuximab is an EGFR-targeted chimeric monoclonal antibody oncology therapy marketed as Erbitux. It is used in metastatic colorectal cancer and head and neck cancers, with biomarker selection in colorectal use. It is administered via intravenous infusion and is prescription-only.
- Trials
- 963
- Recruiting
- 120
- Completed
- 482
- With results
- 280
Last revised
Pipeline
Phase by status
| Phase | Recruiting | Not yet | By invitation | Active | Completed | Terminated | Withdrawn | Suspended | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | — | 1 | — | 1 | 3 | 1 | — | — | — | 6 |
| Phase 1 | 33 | 3 | — | 13 | 87 | 25 | 4 | 1 | 9 | 175 |
| Phase 1/2 | 19 | 3 | — | 10 | 50 | 23 | 8 | 1 | 13 | 127 |
| Phase 2 | 46 | 9 | 1 | 20 | 268 | 66 | 15 | 1 | 64 | 490 |
| Phase 2/3 | — | — | — | 2 | 4 | — | — | 1 | 3 | 10 |
| Phase 3 | 20 | 6 | — | 8 | 49 | 8 | 3 | — | 13 | 107 |
| Phase 4 | 1 | 1 | — | — | 1 | 2 | — | — | 2 | 7 |
| Not applicable | — | 1 | — | — | 7 | 6 | 2 | — | 1 | 17 |
| Unknown | 1 | — | — | — | 13 | 4 | 1 | — | 5 | 24 |
Trials started per year
Conditions studied, by phase
| Condition | Early Phase 1 | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | Phase 4 | Not applicable | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Colorectal Neoplasms | 1 | 59 | 46 | 146 | 4 | 48 | 4 | 5 | 8 | 321 |
| Squamous Cell Carcinoma of Head and Neck | 3 | 32 | 23 | 69 | 3 | 31 | — | 3 | 5 | 169 |
| Head and Neck Neoplasms | 3 | 25 | 13 | 77 | — | 16 | 2 | 4 | 6 | 146 |
| Carcinoma, Non-Small-Cell Lung | — | 29 | 23 | 39 | 1 | 5 | — | — | — | 97 |
| Colonic Neoplasms | 2 | 20 | 7 | 43 | 2 | 15 | — | 1 | 1 | 91 |
| Rectal Neoplasms | 1 | 12 | 6 | 46 | 1 | 12 | — | 3 | 1 | 82 |
| Neoplasm Metastasis | — | 18 | 10 | 35 | 1 | 5 | 2 | — | 2 | 73 |
| Neoplasms | — | 26 | 7 | 25 | — | 1 | — | — | 1 | 60 |
| Carcinoma, Squamous Cell | — | 6 | 8 | 20 | — | 4 | — | — | 2 | 40 |
| Pancreatic Neoplasms | — | 9 | 11 | 16 | — | 1 | — | 2 | — | 39 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | Eli Lilly and Company | 46 | 4 |
| 2 | National Cancer Institute (NCI) | 38 | 6 |
| 3 | M.D. Anderson Cancer Center | 31 | 0 |
| 4 | Merck KGaA, Darmstadt, Germany | 29 | 9 |
| 5 | Fudan University | 18 | 4 |
| 6 | Merck Sharp & Dohme LLC | 16 | 5 |
| 7 | Memorial Sloan Kettering Cancer Center | 15 | 0 |
| 8 | Sun Yat-sen University | 15 | 2 |
| 9 | Bristol-Myers Squibb | 14 | 5 |
| 10 | Pfizer | 13 | 2 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Cetuximab | 963 |
| 2 | Fluorouracil | 175 |
| 3 | Cisplatin | 164 |
| 4 | Irinotecan | 153 |
| 5 | Oxaliplatin | 129 |
| 6 | Bevacizumab | 121 |
| 7 | Leucovorin | 115 |
| 8 | Carboplatin | 83 |
| 9 | Radiotherapy | 80 |
| 10 | Docetaxel | 70 |
Evidence
- Results reported
- 58.1%280 of 482 completed
- Published
- 20.1%97 of 482 completed
- Primary endpoint met
- 34.3%36 of 105 analyses
- Median months to report
- 21
Documents disclosed
Trial profile
- Median enrollment
- 54
- Median duration
- 51.1months
- Countries
- 66
- Study sites
- 12880
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 14
- Phase 1
- 43
- Phase 1/2
- 38
- Phase 2
- 50
- Phase 2/3
- 230
- Phase 3
- 403
- Phase 4
- 139
- Not applicable
- 15
- Unknown
- 79
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | New York | United States | 129 |
| 2 | Houston | United States | 128 |
| 3 | Boston | United States | 106 |
| 4 | Barcelona | Spain | 94 |
| 5 | Nashville | United States | 93 |
| 6 | Los Angeles | United States | 90 |
| 7 | Madrid | Spain | 90 |
| 8 | St Louis | United States | 88 |
| 9 | Philadelphia | United States | 86 |
| 10 | Baltimore | United States | 82 |
Terminations
- Terminated
- 135
- Withdrawn
- 33
- Suspended
- 4
- Stopped for recruitment
- 5.1%49 of 963 trials
Stated reasons
Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.
Recently stopped
| Trial | Status | Stated reason | Stopped |
|---|---|---|---|
| NCT07042295 Suspended | Suspended | Other - planned analysis of safety and efficacy data | 2029-02-28 |
| NCT05200442 Suspended | Suspended | enrollment goal met pending determination of evaluable subjects | 2027-05-01 |
| NCT01810913 Suspended | Suspended | Other - Assessing accrual feasibility | 2027-01-01 |
| NCT06447987 Suspended | Suspended | Pending Interim Analysis | 2026-12-05 |
| NCT06704724 Terminated | Terminated | The trial was terminated for strategic business reasons; the decision was not based on any safety and/or efficacy concerns. | 2026-05-12 |
| NCT01552434 Terminated | Terminated | \< 75 % participation | 2026-05-08 |
| NCT06274437 Terminated | Terminated | Study terminated due to strategic considerations | 2026-04-29 |
| NCT06585488 Terminated | Terminated | The Sponsor has made the decision to terminate this study due to the lack of promising efficacy, internal prioritization, and highly competitive landscape. | 2026-04-23 |
| NCT05576896 Terminated | Terminated | The study was closed due to accrual. | 2026-04-20 |
| NCT06599502 Terminated | Terminated | The decision to cease enrolment and proceed with the early termination of the ALAFOSS 01 (D7080C00001) study was based on strategic company portfolio prioritization. | 2026-01-29 |
Trial records
Individual study records live on ClinicalTrials.gov. A sample of the trials counted above: