Cetuximab: clinical trials recruiting now
47
Recruiting trials
15
Conditions studied
41
US states with sites
42
Countries
FDA drug label
- FDA-approved
- Yes. Cetuximab appears in the FDA drug-label database. Marketed as ERBITUX.
- Drug class
- Epidermal Growth Factor Receptor Antagonist (FDA established pharmacologic class)
- Mechanism of action
- HER1 Antagonists (as stated on the FDA label)
- Boxed warning
- The FDA label for Cetuximab carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
ERBITUX ® is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of: Head and Neck Cancer Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy. ( 1.1 , 14.1 ) Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil. ( 1.1 , 14.1 ) Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy. ( 1.1 , 14.1 ) Colorectal Cancer K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in combination with FOLFIRI for first-line treatment, in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy, as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan. ( 1.2 , 5.7 , 12.1 , 14.2 ) Limitations of Use: ERBITUX is not indicated for treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown. ( 5.7 ) BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC) in combinati…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Labeling: Missing label; potential for missing primary container label on the vial. — Eli Lilly & Co | Class III (FDA: unlikely to cause harm) | Terminated | 2018-11-08 |
Phase breakdown
Phase 1 26
Phase 2 22
Phase 3 8
Not applicable 1
Conditions being studied
Recruiting trials involving Cetuximab
- A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)
- A Multicenter Phase 1b/2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations
- A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors
- A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Colorectal Cancer
- A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer
- A Phase II Study of AMT-676 Combination Therapies in Advanced Colorectal Cancer
- A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colorectal Cancer
- A Phase Ib/II Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +/- Docetaxel in Advanced Squamous Cell Cancers
- A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
- A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy
- A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer
- A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
- A Study of PT0511 in Participants With KRAS Mutated or Amplified Advanced Solid Tumors
- A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer
- A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
- A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies
- A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
- A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
- A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.
- A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
- A Study to Learn More About How Safe BAY 3771249 is and How Well it Works in People With Advanced or Metastatic Colorectal Cancer That Has a KRAS G12D Mutation
- AK129 Combination Therapy for Advanced Solid Tumors
- BBO-11818 in Adult Subjects With KRAS Mutant Cancer
- BRAF Inhibitor Encorafenib And Cetuximab Real Life Investigation of Next Generation CRC Treatment
- Cetuximab, Irinotecan, Toripalimab in RAS/BRAF Wild-type Ultraselected Right-sided Colorectal Cancer Study
- Clinical Study of Second-line Treatment in Advanced Colorectal Cancer With Chemotherapy With Bevacizumab or Cetuximab
- Combination Therapy for BRAF-V600E Metastatic CRCm
- Dual Administration Of Intraperitoneal And Intravenous TROP2-Directed CAR-NK With TGF-Beta Receptor 2 (TGFBR2) Knock Out (KO) Therapy For Colorectal Cancer-Related Peritoneal Carcinomatosis: A Phase 1/2 Trial ("Chip-CRC Trial")
- Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation
- Exploration of Therapeutic Strategies for NeoRAS Wild-type Metastatic Colorectal Cancer Based on Circulating Tumor DNA
- FT836 With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors
- KEYMAKER-U01 Substudy 01J: A Study of Pembrolizumab Plus MK-1084 in Participants With Non-Small Cell Lung Cancer (NSCLC) With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) G12C Mutations (MK-3475-01J/KEYMAKER-U01J)
- MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
- Open-label Phase 1b Study of Ulixertinib and Cetuximab or Ulixertinib in Combination With Cetuximab and Encorafenib in Patients With Unresectable or Metastatic Colorectal Cancer Who Have Previously Received EGFR or BRAF-directed Therapy
- Open-label Phase 2 Study of Avutometinib (RAF/MEK Clamp) in Combination With Defactinib (FAK Inhibitor) and Cetuximab in Patients With Unresectable, Anti-EGFR-Refractory Advanced Colorectal Cancer
- Other Oncogene Mutations for Anti-EGFR Efficacy in Patients With Left-sided RAS-wild Type Metastatic Colorectal Cancer
- Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies
- Rollover Study for Participants Who Have Been Treated With and Are Continuing to Benefit From Opnurasib as a Single Agent or in Combination With Other Study Treatments
- SCRT + Chemo Targeted Immuno-neoadjuvant Therapy for High-risk pMMR/MSS RC
- Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer (LiGeR-CRC1)
- Study of Petosemtamab Plus Chemotherapy Versus Cetuximab or Bevacizumab Plus Chemotherapy in RAS and BRAF Wild Type, Recurrent, Unresectable or Metastatic Colorectal Cancer (LiGeR-CRC2)
- Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors
- Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors
- Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer
- TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers
- Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial
- The Combination of Hypofractionated Radiotherapy and Immunotherapy in Locally Recurrent Rectal Cancer
Common questions
Is Cetuximab FDA-approved?
Yes, marketed as ERBITUX. Its FDA label carries a boxed warning.
How many recruiting trials involve Cetuximab?
47 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.