Afatinib

Generic Name: Afatinib

Brand Names: Gilotrif, Giotrif

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₂₅ClFN_₅O_₃

CAS Number: 850140-72-6

Unique Ingredient Identifier: 41UD74L59M

Background: Afatinib is a 4-anilinoquinazoline tyrosine kinase inhibitor in the form of a dimaleate salt available as Boehringer Ingelheim's brand name Gilotrif . For oral use, afatinib tablets are a first-line (initial) treatment for patients with metastatic non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations as detected by ...

Indication: Afatinib is a kinase inhibitor indicated as monotherapy for the first-line treatment of (a) Epidermal Growth Factor Receptor (EGFR) TKI (tyrosine kinase inhibitor)-naive adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have non-resistant EGFR mutations as detected by an FDA-approved test , and (b) adult pa...

Associated Conditions: Metastatic Non-Small Cell Lung Cancer, Refractory, metastatic squamous cell Non-small cell lung cancer

Associated Therapies: -

Clinical Trials

A Clinical Study on Neoadjuvant Treatment of Resectable Head and Neck Squamous Carcinoma With Immune-targeted Therapy and Lysogenic HSV Virus

Phase 1

Recruiting

Conditions: HNSCC
Neoadjuvant Therapy
Lysogenic HSV Virus
Immunotherapy
Targeted Therapy

Interventions: Biological: Lysogenic HSV virus.
Drug: Tislelizumab
Drug: Afatinib

First Posted Date: 2024-12-19

Last Posted Date: 2024-12-19

Lead Sponsor: West China Hospital

Target Recruit Count: 21

Registration Number: NCT06741982

Locations: 🇨🇳
West China Hospital, Sichuan University, Chengdu, Sichuan, China

Afatinib in Patients with Fanconi Anemia (FA) and Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

Phase 1

Recruiting

Conditions: Fanconi Anemia
Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Afatinib

First Posted Date: 2024-10-18

Last Posted Date: 2024-11-20

Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Target Recruit Count: 25

Registration Number: NCT06648096

Locations: 🇩🇪
Medizinische Hochschule Hannover, Hannover, Germany
🇪🇸
Hospital de la Santa Creu i Sant Pau, Barcelona, Cataluña, Spain

Low-dose Radiotherapy Plus Tislelizumab in Combination With Afatinib for Neoadjuvant Treatment of Surgically Resectable Head and Neck Squamous Carcinoma

Phase 1

Recruiting

Conditions: Head and Neck Cancer

Interventions: Biological: Tislelizumab
Drug: Afatinib
Radiation: Low dose radiotherapy

First Posted Date: 2024-07-10

Last Posted Date: 2024-07-10

Lead Sponsor: West China Hospital

Target Recruit Count: 29

Registration Number: NCT06494189

Locations: 🇨🇳
West China Hospital, Sichuan University, Chengdu, Sichuan, China

Testing Afatinib as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (MATCH - Subprotocol A)

Phase 2

Active, not recruiting

Conditions: Advanced Malignant Solid Neoplasm
Refractory Lymphoma
Refractory Malignant Solid Neoplasm
Refractory Multiple Myeloma
Advanced Lymphoma

Interventions: Drug: Afatinib
Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Echocardiography
Procedure: Magnetic Resonance Imaging
Procedure: Radionuclide Imaging

First Posted Date: 2024-04-26

Last Posted Date: 2024-12-10

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 19

Registration Number: NCT06385483

Locations: 🇺🇸
ECOG-ACRIN Cancer Research Group, Philadelphia, Pennsylvania, United States

Pemigatinib + Afatinib in Advanced Refractory Solid Tumors

Phase 1

Recruiting

Conditions: Advanced Solid Tumor
Cholangiocarcinoma
Metastatic Solid Tumor
Unresectable Solid Tumor

Interventions: Drug: Afatinib
Drug: Pemigatinib

First Posted Date: 2024-03-12

Last Posted Date: 2024-11-18

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 70

Registration Number: NCT06302621

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

Trastuzumab Deruxtecan(T-DXd) and Afatinib Combination in HER2-low Advanced Gastric Cancer

Phase 1

Recruiting

Conditions: Stomach Neoplasm

Interventions: Drug: Trastuzumab deruxtecan
Drug: Afatinib

First Posted Date: 2023-10-17

Last Posted Date: 2024-11-06

Lead Sponsor: Jeeyun Lee

Target Recruit Count: 61

Registration Number: NCT06085755

Locations: 🇰🇷
Samsung Medical Center, Seoul, Korea, Republic of

Palbociclib Combined With Afatinib for Advanced Squamous Carcinoma of Esophagus or Gastroesophageal Junction

Phase 2

Recruiting

Conditions: Esophagus Squamous Cell Carcinoma

Interventions: Drug: Palbociclib
Drug: Afatinib

First Posted Date: 2023-05-18

Last Posted Date: 2023-05-18

Lead Sponsor: AIPING ZHOU

Target Recruit Count: 30

Registration Number: NCT05865132

Locations: 🇨🇳
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing, China

A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway.

Recruiting

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: lorlatinib
Drug: crizotinib
Drug: brigatinib
Drug: ceritinib
Drug: alectinib
Drug: atezolizumab
Drug: bevacizumab
Drug: paclitaxel
Drug: carboplatin
Drug: docetaxel
Drug: erlotinib
Drug: gefitinib
Drug: afatinib
Drug: dacomitinib
Drug: osimertinib
Drug: pembrolizumab
Drug: nivolumab
Drug: entrectinib

First Posted Date: 2023-04-28

Last Posted Date: 2023-10-10

Lead Sponsor: Pfizer

Target Recruit Count: 20605

Registration Number: NCT05834348

Locations: 🇳🇴
Pfizer Norway, Oslo, Norway

To Evaluate the Efficacy and Safety of Afatinib for Advanced ALTRK-negative ESCC

Phase 2

Recruiting

Conditions: Advanced Esophageal Squamous Cell Carcinoma

Interventions: Drug: Afatinib
Drug: Irinotecan

First Posted Date: 2023-04-19

Last Posted Date: 2023-04-19

Lead Sponsor: Peking University

Target Recruit Count: 72

Registration Number: NCT05818982

Locations: 🇨🇳
Xinxiang Central Hospital of Henan Province, Xinxiang, China, Xinxiang, China
🇨🇳
Beijing Cancer Hospital, Beijing, China, Beijing, China
🇨🇳
First Hospital of Xiamen University Affiliated Hospital,Xiamen,China, Xiamen, China

Study to Evaluate the Efficacy of Afatinib in Skull Base Chordoma

Phase 2

Not yet recruiting

Conditions: Chordoma of Clivus

Interventions: Drug: Afatinib

First Posted Date: 2022-08-29

Last Posted Date: 2022-09-30

Lead Sponsor: Huashan Hospital

Target Recruit Count: 20

Registration Number: NCT05519917

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

Drug Development Updates

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