Head and Neck Neoplasms

Oncology
26
Pipeline Programs
11
Companies
32
Clinical Trials
9
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
4
2
6
1
4
9
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
250%
ADC
125%
Small Molecule
125%
+ 16 programs with unclassified modality

On Market (9)

Approved therapies currently available

U
AFATINIBApproved
afatinib
Unknown Company
oral
Eli Lilly and Company
ALIMTAApproved
pemetrexed
Eli Lilly and Company
injection2004
U
BEIZRAYApproved
docetaxel
Unknown Company
Microtubule Inhibitor [EPC]intravenous2024
Boehringer Ingelheim
GILOTRIFApproved
afatinib
Boehringer Ingelheim
Kinase Inhibitor [EPC]oral2013
U
JYLAMVOApproved
methotrexate
Unknown Company
Folate Analog Metabolic Inhibitor [EPC]oral2022
U
METHOTREXATE SODIUMApproved
methotrexate
Unknown Company
oral2020
U
OTREXUPApproved
methotrexate
Unknown Company
Folate Analog Metabolic Inhibitor [EPC]subcutaneous2013
U
OTREXUP PFSApproved
methotrexate
Unknown Company
Folate Analog Metabolic Inhibitor [EPC]subcutaneous2013
Sanofi
TAXOTEREApproved
docetaxel
Sanofi
injection1996

Competitive Landscape

11 companies ranked by most advanced pipeline stage

Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
7 programs
3
1
3
1
AfatinibPhase 3Small Molecule1 trial
MethotrexatePhase 31 trial
PorfiromycinPhase 31 trial
BIBW 2992Phase 21 trial
99mTc - labelled hMAb BIWA 4Phase 11 trial
+2 more programs
Active Trials
NCT02204033Completed33
NCT02209701Terminated3
NCT02254018Completed31
+4 more trials
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
2 programs
1
1
1
pemetrexedPhase 31 trial
PemetrexedPhase 21 trial
Active Trials
NCT01087970Completed69Est. Aug 2013
NCT00415194Completed795Est. Mar 2010
Sanofi
SanofiPARIS, France
1 program
1
1
docetaxelPhase 2/31 trial
Active Trials
NCT00401323Completed568Est. Jun 2003
M&
Merck & Co.RAHWAY, NJ
1 program
1
ARQ 501Phase 21 trial
Active Trials
NCT00358930Completed60Est. Aug 2007
Pfizer
PfizerNEW YORK, NY
1 program
1
PF-00299804Phase 25 trials
Active Trials
NCT01484847Completed6Est. Jul 2015
NCT01313793Completed32Est. May 2011
NCT01318031Completed14Est. Jun 2011
+2 more trials
DS
Daiichi SankyoChina - Shanghai
1 program
1
PatritumabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT02633800Terminated87Est. Feb 2018
Ascendis Pharma
Ascendis PharmaCA - Palo Alto
1 program
1
TransCon TLR7/8 AgonistPhase 21 trial
Active Trials
NCT05980598Terminated27Est. Mar 2025
Tactile Medical
Tactile MedicalMN - Minneapolis
2 programs
1
Head and neck garments for pneumatic compression devicePhase 1/21 trial
Flexitouch head and neck lymphedema treatment systemN/A1 trial
Active Trials
NCT03332160Completed49Est. Jul 2019
NCT02946021Completed11Est. Feb 2018
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
2 programs
1
1
MonalizumabPhase 1/2Monoclonal Antibody1 trial
VCN-01Phase 11 trial
Active Trials
NCT03799744Unknown20Est. Jan 2023
NCT02643550Completed143Est. Mar 2023
One Biosciences
One BiosciencesFrance - Paris
1 program
Community Health Support SpecialistN/A1 trial
Active Trials
NCT07225725Not Yet RecruitingEst. Jan 2027
Novo Nordisk
Novo NordiskBAGSVAERD DENMARK, Denmark
1 program
Needs assesment tool integrated in nursing consultation.N/A1 trial
Active Trials
NCT03443258Completed93Est. Nov 2019

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
Boehringer IngelheimMethotrexate
Boehringer IngelheimAfatinib
Eli Lilly and Companypemetrexed
Boehringer IngelheimPorfiromycin
Sanofidocetaxel
Ascendis PharmaTransCon TLR7/8 Agonist
Daiichi SankyoPatritumab
Eli Lilly and CompanyPemetrexed
PfizerPF-00299804
PfizerPF-00299804
Boehringer IngelheimBIBW 2992
Merck & Co.ARQ 501
Tactile MedicalHead and neck garments for pneumatic compression device
AstraZenecaMonalizumab
AstraZenecaVCN-01

Showing 15 of 32 trials with date data

Clinical Trials (32)

Total enrollment: 3,584 patients across 32 trials

LUX-Head&Neck 3: Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy

Start: Jun 2013Est. completion: Oct 2024340 patients
Phase 3Completed

LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy

Start: Jan 2012Est. completion: Dec 2016483 patients
Phase 3Completed

A Study for Patients With Head and Neck Cancer

Start: Dec 2006Est. completion: Mar 2010795 patients
Phase 3Completed

Porfiromycin Used as an Adjuvant to Radiation Therapy in Postoperative Head and Neck Cancer Patients

Start: May 20003 patients
Phase 3Terminated

Taxotere (Docetaxel) in 1st Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Start: Jan 1998Est. completion: Jun 2003568 patients
Phase 2/3Completed
NCT05980598Ascendis PharmaTransCon TLR7/8 Agonist

TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma

Start: Sep 2023Est. completion: Mar 202527 patients
Phase 2Terminated

Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN )

Start: Dec 2015Est. completion: Feb 201887 patients
Phase 2Terminated

A Study for Participants With Recurrent or Metastatic Squamous Cell Head and Neck Cancer

Start: Aug 2010Est. completion: Aug 201369 patients
Phase 2Completed

Open-Label Trial Of Oral PF-00299804 By Continuous Dosing In Patients With Recurrent Or Metastatic Head And Neck Squamous Cell Cancer

Start: Nov 2008Est. completion: Apr 201269 patients
Phase 2Completed

A Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen

Start: Nov 2008Est. completion: Aug 2014188 patients
Phase 2Completed

BIBW 2992 (Afatinib) in Head & Neck Cancer

Start: Aug 2007Est. completion: Jul 2013124 patients
Phase 2Completed

A Study of ARQ 501 in Patients With Squamous Cell Carcinoma of the Head and Neck

Start: Jul 2006Est. completion: Aug 200760 patients
Phase 2Completed
NCT02946021Tactile MedicalHead and neck garments for pneumatic compression device

Response to Intermittent Pneumatic Compression Therapy in Head and Neck Cancer-Related Lymphedema

Start: Oct 2016Est. completion: Feb 201811 patients
Phase 1/2Completed

Study of Monalizumab and Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Start: Dec 2015Est. completion: Mar 2023143 patients
Phase 1/2Completed

Safety,Tolerability,and Efficacy of VCN-01 With Durvalumab in R/M Head and Neck Squamous Cell Carcinoma

Start: Mar 2019Est. completion: Jan 202320 patients
Phase 1Unknown

A Bioequivalence (BE) Study Comparing The Commericializable And Clinical Formulations Of PF-00299804

Start: Apr 2011Est. completion: May 201132 patients
Phase 1Completed

Study To Investigate The Potential Drug Drug Interaction (DDI) Between PF-00299804 And Paroxetine In Healthy Subjects

Start: Mar 2011Est. completion: Jun 201114 patients
Phase 1Completed

A Study Of Combined C- MET Inhibitor And PAN-HER Inhibitor (PF-02341066 And PF-00299804) In Patients With Non- Small Cell Lung Cancer

Start: Aug 2010Est. completion: Feb 201470 patients
Phase 1Completed

A Study In Patients Who Will Undergo Surgical Removal Of Non-Small Cell Lung Cancer To Evaluate Molecular Changes That Occur In Tumor Tissue After Short Term Exposure To PF-00299804

Start: Feb 2010Est. completion: May 201222 patients
Phase 1Terminated

A Radiolabeled Mass Balance Study Of [14C]PF-00299804 In Healthy Male Volunteers

Start: Jan 2010Est. completion: Feb 20106 patients
Phase 1Completed

A Pharmacokinetic (PK) Study Of PF-00299804 And Dextromethorphan In Healthy Volunteers

Start: Nov 2009Est. completion: Dec 200914 patients
Phase 1Completed

A Safety And Efficacy Study Of The Combination Of Oral PF-00299804 And Intravenous CP-751,871 Given Every 3 Weeks

Start: Dec 2008Est. completion: Jan 201374 patients
Phase 1Completed

A Study Of PF-00299804 In Patients In Japan With Advanced Malignant Solid Tumors

Start: Nov 2008Est. completion: Mar 201113 patients
Phase 1Completed

A Study To Test The Impact Of PF- 00299804 On How The Body Handles Dextromethorphan In Cancer Patients

Start: Sep 2008Est. completion: Jul 201416 patients
Phase 1Completed

Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of PF-00299804 In Patients With Advanced Solid Tumors

Start: Oct 2005Est. completion: Sep 2010121 patients
Phase 1Completed
NCT02254018Boehringer Ingelheimbivatuzumab mertansine

Single Dose Escalation Study of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck

Start: Sep 200231 patients
Phase 1Completed

Pharmacokinetic Study of Porfiromycin in Head and Neck Cancer and Other Cancer Patients With Solid Tumors

Start: Dec 19993 patients
Phase 1Terminated
NCT02204033Boehringer Ingelheim99mTc - labelled hMAb BIWA 4

Dose Escalation Study With 99mTC - or 186 Re-labelled Humanised Monoclonal Antibody (hMAb) BIWA 4 in Patients With Head and Neck Cancer

Start: Mar 199933 patients
Phase 1Completed
NCT07225725One BiosciencesCommunity Health Support Specialist

Access to Care Pilot for ED-Presenting Head and Neck Cancer Patients (ENRICH-HNC)

Start: Feb 2026Est. completion: Jan 2027
N/ANot Yet Recruiting
NCT03443258Novo NordiskNeeds assesment tool integrated in nursing consultation.

Needs Assessment Tool Integrated in Clinical Practice of Head and Neck Cancer Rehabilitation

Start: Jun 2018Est. completion: Nov 201993 patients
N/ACompleted
NCT03332160Tactile MedicalFlexitouch head and neck lymphedema treatment system

A Pilot Study to Evaluate the Feasibility and Potential Effectiveness of the Flexitouch System Head and Neck Treatment

Start: Jan 2018Est. completion: Jul 201949 patients
N/ACompleted

A Study of PF-00299804 When Given Through a Feeding Tube in Locally Advanced Head and Neck Squamous Cell Carcinoma

Start: Dec 2011Est. completion: Jul 20156 patients
N/ACompleted

Related Jobs in Oncology

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

4 late-stage (Phase 3) programs — potential near-term approvals
11 companies competing in this space