Afatinib clinical trials
Afatinib is named as an intervention in 15 current clinical trials in our China, Germany, USA, Spain, Netherlands, Canada, South Korea, Taiwan, UK, Italy, Belgium, Austria, Japan, Australia, Norway, Mexico, Israel, Egypt and Singapore registers. 8 are recruiting patients now. The most common phase is Phase 1/2. The sponsor with the most trials is West China Hospital (2). The most-studied condition is Cancer.
Where Afatinib is approved
All regulators →Of the three regulators tracked here, the first to approve Afatinib was the EU, on 25 Sep 2013.
- 2 EU orphan designations, most recently for treatment of complex regional pain syndrome (28 Jun 2024, positive)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Afatinib
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Afatinib works
All drug targets →- Epidermal growth factor receptor erbB1 inhibitor InhibitorTarget: EGFR epidermal growth factor receptor✓ In ChEMBL and the Guide to Pharmacology
- Receptor protein-tyrosine kinase erbB-2 inhibitor InhibitorTarget: ERBB2 erb-b2 receptor tyrosine kinase 2✓ In ChEMBL and the Guide to Pharmacology
- Receptor protein-tyrosine kinase erbB-4 inhibitor InhibitorTarget: ERBB4 erb-b2 receptor tyrosine kinase 4ChEMBL only
- Breast cancerPhase 3
- Head and neck squamous cell carcinomaPhase 3
- Lung adenocarcinomaPhase 3
- Squamous cell carcinomaPhase 3
- Squamous cell lung carcinomaPhase 3
- CancerPhase 2
- CholangiocarcinomaPhase 2
- ChordomaPhase 2
- Colorectal cancerPhase 2
- Cutaneous squamous cell carcinomaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1173655, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 5667, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Afatinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Afatinib. 2 are current, and 1 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Afatinib for treating advanced squamous non-small-cell lung cancer after platinum-based chemotherapy (terminated appraisal) NICE TA444 | Terminated (no company submission) | 24 May 2017 | Current |
| Afatinib for treating epidermal growth factor receptor mutation-positive locally advanced or metastatic non-small-cell lung cancer NICE TA310 | Recommended | 23 Apr 2014 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Afatinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- EUEuropean Union: GiotrifEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Afatinib
- ATC code
- L01XE13
- ChEMBL
- CHEMBL1173655
- DrugBank
- DB08916
- PubChem CID
- 10184653
- CAS number
- 850140-72-6
- FDA UNII
- 41UD74L59M
- Wikidata
- Q4688818
- Wikipedia
- Afatinib
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Afatinib
15 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Conditions studied with Afatinib
29 conditionsAll 29 conditions
| Condition (as registered) | Trials |
|---|---|
| Cancer | 2 |
| Advanced Solid Tumors | 1 |
| Kirsten Rat Sarcoma (KRAS) pG12C Mutation | 1 |
| Advanced Cancer | 1 |
| Metastatic Cancer | 1 |
| Malignant Neoplastic Disease | 1 |
| Non Small Cell Lung Cancer | 1 |
| Esophagus Cancer | 1 |
| HNSCC | 1 |
| Lysogenic HSV Virus | 1 |
| Neoadjuvant Therapy | 1 |
| Immunotherapy | 1 |
| Carcinoma, Non-Small-Cell Lung | 1 |
| Non-squamous NSCLC | 1 |
| Fanconi Anemia | 1 |
| Head and Neck Squamous Cell Carcinoma | 1 |
| Tumors | 1 |
| Neoplasm | 1 |
| Neoplasia | 1 |
| Advanced Lymphoma | 1 |
| Advanced Malignant Solid Neoplasm | 1 |
| Bladder Carcinoma | 1 |
| Breast Carcinoma | 1 |
| Glioblastoma | 1 |
| Recurrent Disease | 1 |
| Recurrent Glioblastoma | 1 |
| Stomach Neoplasm | 1 |
| NSCLC Stage IV | 1 |
| NSCLC | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| West China Hospital | 2 |
| Amgen | 1 |
| Mirati Therapeutics Inc | 1 |
| Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd | 1 |
| Shandong University | 1 |
| Shandong Public Health Clinical Center | 1 |
| Michael Hopp | 1 |
| Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | 1 |
| The Netherlands Cancer Institute | 1 |
| National Cancer Institute (NCI) | 1 |
| AHS Cancer Control Alberta | 1 |
| Jeeyun Lee | 1 |
| National Taiwan University Hospital | 1 |
| National University Hospital, Singapore | 1 |
By country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Afatinib trials
How many clinical trials are testing Afatinib?
15 current trials in our China, Germany, USA, Spain, Netherlands, Canada, South Korea, Taiwan, UK, Italy, Belgium, Austria, Japan, Australia, Norway, Mexico, Israel, Egypt and Singapore registers name Afatinib (also registered as BIBW 2992) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Afatinib trials recruiting patients?
Yes. 8 of the 15 trials are recruiting: 3 with sites in China, 1 with sites in Germany, 1 with sites in Spain, 1 with sites in Netherlands, 1 with sites in South Korea, 1 with sites in Taiwan and 1 with sites in Singapore. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Afatinib clinical trials?
West China Hospital (2), Amgen (1), Mirati Therapeutics Inc (1) and Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd (1), among 14 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Afatinib works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Afatinib works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Afatinib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.