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Drug

Erlotinib Hydrochloride

In clinical development
ClassEpidermal growth factor receptor erbB1 inhibitorEmerging researchLate-stage developmentCooling momentum

Also known as Erlotinib, erlotinib HCl.

RxNorm477320ChEMBLCHEMBL1079742UNIIDA87705X9K
9
Research papers
8
Active clinical trials
Epidermal growth factor receptor
Primary target
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Randomized Phase II Trial of Erlotinib, Cabozantinib, or Erlotinib Plus Cabozantinib as 2nd or 3rd Line Therapy in Patients With EGFR Wild-Type NSCLC

Clinical trial2026-07-02Results posted · ClinicalTrials.gov

Phase II Clinical Trial of Low-dose Erlotinib for Hepatocellular Carcinoma Chemoprevention

Clinical trial2026-06-24Results expected Q2 2030 · ClinicalTrials.gov

Maintenance Systemic Therapy Versus Local Consolidative Therapy (LCT) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial

Clinical trial2026-06-08Results posted · ClinicalTrials.gov

MC240701 Decentralized Pilot Study of Triple Oral Metronomic Chemotherapy for Patients With Recurrent/Metastatic Head and Neck Cancer in a Rural Midwest United States Population

Clinical trial2026-05-11Results expected Q2 2028 · ClinicalTrials.gov

A Phase II-R and a Phase III Trial Evaluating Both Erlotinib (Ph II-R) and Chemoradiation (Ph III) as Adjuvant Treatment for Patients With Resected Head of Pancreas Adenocarcinoma

Clinical trial2026-02-23Results posted · ClinicalTrials.gov

Randomized Study of Erlotinib Vs Observation in Patients With Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)

Clinical trial2025-12-06Primary completion · ClinicalTrials.gov

Phase Ib Study of Erlotinib Prior to Surgery in Patients With Head and Neck Cancer

Clinical trial2025-04-30Completed · ClinicalTrials.gov

A Phase 1/2 Trial of Erlotinib and Onalespib Lactate in EGFR-Mutant Non-Small Cell Lung Cancer

Clinical trial2025-03-03Results posted · ClinicalTrials.gov

Overall Survival with Osimertinib in Untreated, <i>EGFR</i>-Mutated Advanced NSCLC.

Research2019-11-21The New England journal of medicine

Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer.

Research2017-11-18The New England journal of medicine

Phase 2 study of erlotinib combined with adjuvant chemoradiation and chemotherapy in patients with resectable pancreatic cancer.

Research2013-07-01International journal of radiation oncology, biology, physics

NABTT 0502: a phase II and pharmacokinetic study of erlotinib and sorafenib for patients with progressive or recurrent glioblastoma multiforme.

Research2013-01-17Neuro-oncology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Erlotinib Hydrochloride
Aliases & brands
Erlotiniberlotinib HCl
RxNorm CUI
477320
ChEMBL ID
CHEMBL1079742
UNII
DA87705X9K
Primary mechanism
Epidermal growth factor receptor erbB1 inhibitor

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Epidermal growth factor receptor
EGFR · P00533
INHIBITOREpidermal growth factor receptor erbB1 inhibitor

Clinical trials

183 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
183
registered trials across all phases
LATEST COMPLETION 2025
8
Active studies
2
Recruiting
17
Late-stage (III+)
136
Completed
39
Discontinued
PHASE DISTRIBUTIONn = 183
Early Phase 11Phase 145Phase 1 / 224Phase 296Phase 2 / 32Phase 312Phase 41Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions

CompletedPH IVQuadras Scientific Solutionsn=242008

Randomized Study of Erlotinib Vs Observation in Patients With Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)

Active, not recruitingPH IIINational Cancer Institute (NCI)n=3902027

A Phase II-R and a Phase III Trial Evaluating Both Erlotinib (Ph II-R) and Chemoradiation (Ph III) as Adjuvant Treatment for Patients With Resected Head of Pancreas Adenocarcinoma

CompletedPH IIINational Cancer Institute (NCI)n=5462025

Intercalated Combination of Erlotinib and Radiotherapy for Patients With EGFR-mutant, Unresectable, Locally Advanced Non-small-cell Lung Cancer

Unknown statusPH II/IIIGuangdong Provincial People's Hospitaln=902020

A Phase III, Multicenter, Placebo-Controlled, Double-Blind, Randomized Clinical Trial to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva (Erlotinib) Compared With Tarceva Alone for Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) After Failure of Standard First-Line Chemotherapy

CompletedPH IIIGenentech, Inc.n=6362019

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase II-R and a Phase III Trial Evaluating Both Erlotinib (Ph II-R) and Chemoradiation (Ph III) as Adjuvant Treatment for Patients With Resected Head of Pancreas Adenocarcinoma

CompletedPH IIINational Cancer Institute (NCI)n=5462025

Phase Ib Study of Erlotinib Prior to Surgery in Patients With Head and Neck Cancer

CompletedPH IM.D. Anderson Cancer Centern=482025

Neoadjuvant Chemotherapy With Docetaxel, Cisplatin Followed by Maintenance Therapy With the EGFR Inhibitor Erlotinib (Tarceva) in Patients With Stage I, II and III Non-Small Cell Lung Cancer Following Definitive Surgical Resection

CompletedPH IM.D. Anderson Cancer Centern=502024

Pilot Study of EGFR Inhibition With Erlotinib in Cirrhosis to Inhibit Fibrogenesis and Prevent Hepatocellular Carcinoma

CompletedPH I/IINational Cancer Institute (NCI)n=252022

Phase II Trial of Weekly Erlotinib Dosing to Reduce Duodenal Polyp Burden Associated With Familial Adenomatous Polyposis

CompletedPH IINational Cancer Institute (NCI)n=462021

A Phase 1/2 Trial of Erlotinib and Onalespib Lactate in EGFR-Mutant Non-Small Cell Lung Cancer

CompletedPH I/IINational Cancer Institute (NCI)n=112021

Research activity

9 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20052020
Most influential

Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer.

The New England journal of medicine · 2018 · 4,173 cites

Overall Survival with Osimertinib in Untreated, <i>EGFR</i>-Mutated Advanced NSCLC.

The New England journal of medicine · 2020 · 2,267 cites

Clinical features and outcome of patients with non-small-cell lung cancer who harbor EML4-ALK.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2009 · 1,412 cites

TRIBUTE: a phase III trial of erlotinib hydrochloride (OSI-774) combined with carboplatin and paclitaxel chemotherapy in advanced non-small-cell lung cancer.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2005 · 1,017 cites

Molecular determinants of the response of glioblastomas to EGFR kinase inhibitors.

The New England journal of medicine · 2005 · 994 cites

NABTT 0502: a phase II and pharmacokinetic study of erlotinib and sorafenib for patients with progressive or recurrent glioblastoma multiforme.

Neuro-oncology · 2013 · 73 cites
Recent papers

Overall Survival with Osimertinib in Untreated, <i>EGFR</i>-Mutated Advanced NSCLC.

The New England journal of medicine · 2020 · 2,267 cites

Osimertinib in Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer.

The New England journal of medicine · 2018 · 4,173 cites

NABTT 0502: a phase II and pharmacokinetic study of erlotinib and sorafenib for patients with progressive or recurrent glioblastoma multiforme.

Neuro-oncology · 2013 · 73 cites

Phase 2 study of erlotinib combined with adjuvant chemoradiation and chemotherapy in patients with resectable pancreatic cancer.

International journal of radiation oncology, biology, physics · 2013 · 26 cites

A phase II study of bevacizumab plus erlotinib for gemcitabine-refractory metastatic pancreatic cancer.

Cancer chemotherapy and pharmacology · 2010 · 55 cites

Clinical features and outcome of patients with non-small-cell lung cancer who harbor EML4-ALK.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2009 · 1,412 cites
Major research themes3
Antimetabolites, Antineoplastic1Drug Resistance, Neoplasm1Mutation1
Journals, researchers & institutions
Top journals
  • The New England journal of medicine3
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology2
  • Cancer chemotherapy and pharmacology1
  • Clinical breast cancer1
  • International journal of radiation oncology, biology, physics1
  • Neuro-oncology1
Leading researchers
  • Cheng Y2
  • Chewaskulyong B2
  • Cho BC2
  • Gray JE2
  • Hodge R2
  • Imamura F2
  • Kurata T2
  • Lee KH2
Leading institutions
free-text, unnormalised
  • Cleveland Clinic1
  • David Geffen School of Medicine at the University of California1
  • From Gustave Roussy Cancer Campus and University Paris-Sud1
  • From Winship Cancer Institute1
  • Massachusetts General Hospital1
  • Sidney Kimmel Comprehensive Cancer Center1

Related diseases

2 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Related drugs

4 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Gefitinib

Acts on the same molecular target as Erlotinib Hydrochloride, with 4 overlapping disease areas.

Shared target4 shared diseases4 shared papers
Osimertinib

Acts on the same molecular target as Erlotinib Hydrochloride, with 2 overlapping disease areas.

Shared target2 shared diseases2 shared papers
Carboplatin

Studied across 2 of the same disease areas as Erlotinib Hydrochloride in the shared literature.

2 shared diseases1 shared paper
Paclitaxel

Studied across 2 of the same disease areas as Erlotinib Hydrochloride in the shared literature.

2 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials