Erlotinib

Generic Name: Erlotinib

Brand Names: Tarceva

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₂₃N_₃O_₄

CAS Number: 183321-74-6

Unique Ingredient Identifier: J4T82NDH7E

Background: Erlotinib is an inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase that is used in the treatment of non-small cell lung cancer, pancreatic cancer and several other types of cancer. It is typically marketed under the trade name Tarceva. Erlotinib binds to the epidermal growth factor receptor (EGFR) tyrosine kinase in a reversible fashion at the adenosine triphosphate (ATP) binding site of the receptor. Recent studies demonstrate that erlotinib is also a potent inhibitor of JAK2V617F, which is a mutant form of tyrosine kinase JAK2 found in most patients with polycythemia vera (PV) and a substantial proportion of patients with idiopathic myelofibrosis or essential thrombocythemia. This finding introduces the potential use of erlotinib in the treatment of JAK2V617F-positive PV and other myeloproliferative disorders.

Indication: Erlotinib is indicated for:

The safety and efficacy of erlotinib have not been established for patients with NSCLC whose tumors show other EGFR mutations. Additionally it is not recommended for use in combination with platinum-based chemotherapy.

Associated Conditions: Locally Advanced Pancreatic Cancer (LAPC), Metastatic Non-Small Cell Lung Cancer, Pancreatic Metastatic Cancer, Unresectable Pancreatic Cancer

Clinical Trials

EGFR-TKIs Combine With Anlotinib as First-line Treatment for Patients With Advanced EGFR Mutation-positive NSCLC

Phase 2

Conditions: EGFR Gene Mutation

Interventions: Drug: erlotinib or gefitinib or icotinib
Drug: Anlotinib

First Posted Date: 2018-10-25

Last Posted Date: 2018-10-25

Lead Sponsor: Fujian Cancer Hospital

Target Recruit Count: 90

Registration Number: NCT03720873

Locations: 🇨🇳
Fujian cancer hospital, Fuzhou, Fujian, China

First Line Treatment in EGFR Mutation Positive Advanced NSCLC Patients with Central Nervous System (CNS) Metastases

Phase 2

Completed

Conditions: EGFR Gene Mutation
Non-small Cell Lung Cancer
Brain Metastases

Interventions: Drug: AZD3759
Drug: Erlotinib
Drug: Gefitinib

First Posted Date: 2018-08-31

Last Posted Date: 2024-10-15

Lead Sponsor: Alpha Biopharma (Jiangsu) Co., Ltd.

Target Recruit Count: 492

Registration Number: NCT03653546

Locations: 🇨🇳
China site, Tianjin, China
🇨🇳
China site 0123, Jinan, Shandong, China
🇰🇷
Korea Site, Seoul, Korea, Republic of

and more 3 locations

Phase III Study of Nazartinib (EGF816) Versus Erlotinib/Gefitinib in First-line Locally Advanced / Metastatic NSCLC With EGFR Activating Mutations

Phase 3

Withdrawn

Conditions: Carcinoma, Non-small Cell Lung

Interventions: Drug: EFG816
Drug: erlotinib or gefitinib

First Posted Date: 2018-05-18

Last Posted Date: 2019-11-22

Lead Sponsor: Novartis Pharmaceuticals

Registration Number: NCT03529084

A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site

Phase 2

Completed

Conditions: Cancer of Unknown Primary Site

Interventions: Drug: Alectinib
Drug: Vismodegib
Drug: Carboplatin
Drug: Ipatasertib
Drug: Olaparib
Drug: Erlotinib
Drug: Cisplatin
Drug: Bevacizumab
Drug: Gemcitabine
Drug: Vemurafenib
Drug: Cobimetinib
Drug: Trastuzumab Subcutaneous (SC)
Drug: Pertuzumab
Drug: Atezolizumab
Drug: Paclitaxel
Drug: Entrectinib
Drug: Ivosidenib
Drug: Pemigatinib

First Posted Date: 2018-04-13

Last Posted Date: 2025-02-04

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 528

Registration Number: NCT03498521

Locations: 🇫🇷
Centre Antoine Lacassagne, Nice, France
🇫🇷
Institut Curie, Paris, France
🇫🇷
CHU Lyon - Centre Hospitalier Lyon Sud, Pierre-Benite (Lyon), France

and more 127 locations

Randomized Comparative Study of Erlotinib and Pemetrexed in the Maintenance Treatment of Advanced Lung Cancer Patients.

Phase 4

Terminated

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: Pemetrexed
Drug: Erlotinib

First Posted Date: 2018-03-09

Last Posted Date: 2020-03-05

Lead Sponsor: Hikma Pharmaceuticals LLC

Target Recruit Count: 9

Registration Number: NCT03460678

Locations: 🇯🇴
King Hussein Cancer Center (KHCC), Amman, Jordan
🇱🇧
American University of Beirut Medical Center, Beirut, Lebanon

Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)

Phase 2

Recruiting

Conditions: Lymphoma, Non-Hodgkin
Multiple Myeloma
Advanced Solid Tumors

Interventions: Drug: Erlotinib
Drug: Dasatinib
Drug: Axitinib
Drug: Bosutinib
Drug: Crizotinib
Drug: Nivolumab plus Ipilimumab
Drug: Olaparib
Drug: Palbociclib
Drug: Sunitinib
Drug: Temsirolimus
Drug: Trastuzumab plus Pertuzumab
Drug: Vemurafenib plus Cobimetinib
Drug: Vismodegib
Drug: Tucatinib

First Posted Date: 2017-09-29

Last Posted Date: 2025-03-11

Lead Sponsor: Canadian Cancer Trials Group

Target Recruit Count: 720

Registration Number: NCT03297606

Locations: 🇨🇦
London Health Sciences Centre Research Inc., London, Ontario, Canada
🇨🇦
Cross Cancer Institute, Edmonton, Alberta, Canada
🇨🇦
BCCA - Kelowna, Kelowna, British Columbia, Canada

and more 7 locations

Efficacy and Safety of Precision Therapy in Refractory Tumor

Phase 2

Conditions: Rare Tumor
Refractory Tumor

Interventions: Drug: Gefitinib
Drug: Erlotinib
Drug: Afatinib
Drug: Trastuzumab
Drug: Oxazolidine
Drug: Olaparib
Drug: Everolimus
Drug: Cabozantinib
Drug: Vemurafenib
Drug: Dabrafenib
Drug: Palbociclib
Drug: PD-1/L1 inhibitor plus anti-angiogenic agent

First Posted Date: 2017-08-03

Last Posted Date: 2022-03-04

Lead Sponsor: Baodong Qin

Target Recruit Count: 300

Registration Number: NCT03239015

Locations: 🇨🇳
Shanghai Changzheng Hospital, Shanghai, Shanghai, China

Cabozantinib and Erlotinib for Patients With EGFR and c-Met Co-expressing Metastatic Pancreatic Adenocarcinoma

Phase 2

Terminated

Conditions: Pancreatic Adenocarcinoma Metastatic

Interventions: Drug: Cabozantinib 40 MG
Drug: Erlotinib 100Mg Tab

First Posted Date: 2017-07-11

Last Posted Date: 2020-08-27

Lead Sponsor: Patrick Joseph Loehrer Sr.

Target Recruit Count: 7

Registration Number: NCT03213626

Locations: 🇺🇸
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
🇺🇸
Indiana University Health Hospital, Indianapolis, Indiana, United States

Maintenance Chemotherapy With or Without Local Consolidative Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer

Phase 2

Active, not recruiting

Conditions: Recurrent Non-Small Cell Lung Carcinoma
Stage IV Non-Small Cell Lung Cancer

Interventions: Drug: Docetaxel
Radiation: 3-Dimensional Conformal Radiation Therapy (3D-CRT)
Drug: Gemcitabine
Drug: Pemetrexed Disodium
Drug: Erlotinib Hydrochloride
Radiation: Intensity-Modulated Radiation Therapy (IMRT)
Drug: Pembrolizumab
Radiation: Stereotactic Body Radiation Therapy (SBRT)

First Posted Date: 2017-05-03

Last Posted Date: 2025-03-11

Lead Sponsor: NRG Oncology

Target Recruit Count: 218

Registration Number: NCT03137771

Locations: 🇺🇸
Arizona Center for Cancer Care - Gilbert, Gilbert, Arizona, United States
🇺🇸
Arizona Center for Cancer Care - Scottsdale, Scottsdale, Arizona, United States
🇺🇸
Los Angeles General Medical Center, Los Angeles, California, United States

and more 298 locations

A Study of Tarceva vs. Avastin+Tarceva for Advanced NSCLC With EGFR m(+)

Phase 2

Conditions: EGFR Positive Non-small Cell Lung Cancer

Interventions: Drug: Erlotinib plus Bevacizumab
Drug: Erlotinib

First Posted Date: 2017-04-24

Last Posted Date: 2022-04-06

Lead Sponsor: National Cancer Center, Korea

Target Recruit Count: 128

Registration Number: NCT03126799

Locations: 🇰🇷
National Cancer Center, Goyang-Si, Gyeonggi-do, Korea, Republic of

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