Erlotinib clinical trials
Erlotinib is named as an intervention in 15 current clinical trials in our Canada, South Korea, Israel, China, USA, Italy, Taiwan, Mexico, Spain, Netherlands, Norway, France, Japan, UK, Belgium, Poland, Brazil, Germany, Turkey, Switzerland, Australia, Austria and Denmark registers. 6 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is National Cancer Institute (NCI) (3). The most-studied condition is Advanced Solid Tumors. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Erlotinib is approved
All regulators →Of the three regulators tracked here, the first to approve Erlotinib was the US, on 18 Nov 2004. It is approved in 3 of the 3 regulators tracked here.
- 2 EU orphan designations, most recently for treatment of pachyonychia congenita (18 Jul 2022, 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 Erlotinib
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 Erlotinib works
All drug targets →- Epidermal growth factor receptor erbB1 inhibitor InhibitorTarget: EGFR epidermal growth factor receptor✓ In ChEMBL and the Guide to Pharmacology
- Carcinoma of esophagusPhase 3
- Colorectal cancerPhase 3
- Exocrine pancreatic carcinomaPhase 3
- Fallopian tube cancerPhase 3
- Head and neck squamous cell carcinomaPhase 3
- Hepatocellular carcinomaPhase 3
- Lung cancerPhase 3
- Malignant epithelial tumor of ovaryPhase 3
- Malignant pancreatic neoplasmPhase 3
- Metastatic colorectal cancerPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL553, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 4920, 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 Erlotinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 4 technology appraisals of Erlotinib. 4 are current, and 3 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Erlotinib and gefitinib for treating non-small-cell lung cancer that has progressed after prior chemotherapy NICE TA374 | Optimised Not recommended | 16 Dec 2015 | Current |
| Erlotinib for the first-line treatment of locally advanced or metastatic EGFR-TK mutation-positive non-small-cell lung cancer NICE TA258 | Recommended | 27 Jun 2012 | Current |
| Erlotinib monotherapy for maintenance treatment of non-small-cell lung cancer NICE TA227 | Not recommended | 29 Jun 2011 | Current |
| Erlotinib for the treatment of non-small-cell lung cancer NICE TA162 | Recommended Not recommended | 26 Nov 2008 Updated 1 Dec 2012 | 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 Erlotinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 3 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: TarcevaEMA 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 Erlotinib
- ATC code
- L01XE03
- ChEMBL
- CHEMBL553
- DrugBank
- DB00530
- PubChem CID
- 176870
- CAS number
- 183321-74-6
- FDA UNII
- J4T82NDH7E
- Wikidata
- Q418369
- Wikipedia
- Erlotinib
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 Erlotinib
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.
Erlotinib in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Erlotinib. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
TAILOR-PANC: Molecularly Tailored Therapy versus Standard Care in Advanced Pancreatic Cancer (DPCG-02)
2025-522431-34-00 · CTIS ↗ · Neoplasms
|
Phase 2 | Authorised | Region Hovedstaden | Denmark |
Erlotinib across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
3 single-substance products containing Erlotinib on the HPRA medicines list.
- Tarceva 100mg film-coated tabletsCheplapharm Registration GmbH · EU/1/05/311/002
- Tarceva 150 mg film-coated tabletsCheplapharm Registration GmbH · EU/1/05/311/003
- Tarceva 25 mg film-coated tabletsCheplapharm Registration GmbH · EU/1/05/311/001
Supply shortages
No entry for Erlotinib in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Erlotinib
31 conditionsAll 31 conditions
| Condition (as registered) | Trials |
|---|---|
| Advanced Solid Tumors | 2 |
| Non Small Cell Lung Cancer | 2 |
| Cancer | 2 |
| Tumors | 2 |
| Neoplasia | 2 |
| Stage IB Lung Non-Small Cell Carcinoma AJCC v7 | 2 |
| Stage II Lung Non-Small Cell Cancer AJCC v7 | 2 |
| Non-Small Cell Lung Cancer | 1 |
| Colorectal Cancer | 1 |
| Metastatic Non-Small Cell Lung Cancer | 1 |
| Advanced Solid Tumors Cancer | 1 |
| AMD - Age-Related Macular Degeneration | 1 |
| EGFR Gene Mutation | 1 |
| ALK Gene Mutation | 1 |
| ROS1 Gene Mutation | 1 |
| Neoplasm | 1 |
| Neoplasms | 1 |
| Stage IIA Lung Cancer AJCC v8 | 1 |
| Stage IIB Lung Cancer AJCC v8 | 1 |
| Lymphoma, Non-Hodgkin | 1 |
| Multiple Myeloma | 1 |
| Solid Tumor | 1 |
| Advanced Solid Tumor | 1 |
| Metastatic Cancer | 1 |
| Non-small Cell Lung Cancer | 1 |
| Lung Non-Squamous Non-Small Cell Carcinoma | 1 |
| Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | 1 |
| Recurrent Non-Small Cell Lung Carcinoma | 1 |
| Stage IV Non-Small Cell Lung Cancer | 1 |
| Recurrent Lung Non-Small Cell Carcinoma | 1 |
| Stage IV Lung Non-Small Cell Cancer AJCC v7 | 1 |
Sponsors
lead sponsor per trialBy country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Erlotinib trials
How many clinical trials are testing Erlotinib?
15 current trials in our Canada, South Korea, Israel, China, USA, Italy, Taiwan, Mexico, Spain, Netherlands, Norway, France, Japan, UK, Belgium, Poland, Brazil, Germany, Turkey, Switzerland, Australia, Austria and Denmark registers name Erlotinib (also registered as CP 358) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Erlotinib trials recruiting patients?
Yes. 6 of the 15 trials are recruiting: 1 with sites in Canada, 2 with sites in China, 1 with sites in Taiwan, 1 with sites in Netherlands and 1 with sites in Denmark. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Erlotinib clinical trials?
National Cancer Institute (NCI) (3), Eli Lilly and Company (2), Genentech, Inc (1) and AbbVie (1), among 12 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Erlotinib licensed in Ireland?
Yes. The HPRA medicines list includes 3 single-substance products containing Erlotinib, for example Tarceva 100mg film-coated tablets (Cheplapharm Registration GmbH). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Erlotinib shortage?
Not in the lists we track: Erlotinib has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
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 Erlotinib 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 Erlotinib 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 Erlotinib (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.