Lapatinib clinical trials
Lapatinib is named as an intervention in 3 current clinical trials in our China and France registers. 3 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Tianjin Hemay Pharmaceutical Co., Ltd (1). The most-studied condition is Breast Cancer.
Where Lapatinib is approved
All regulators →Of the three regulators tracked here, the first to approve Lapatinib was the EU, on 10 Jun 2008.
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.
How Lapatinib works
All drug targets →- Receptor protein-tyrosine kinase erbB-2 inhibitor InhibitorTarget: ERBB2 erb-b2 receptor tyrosine kinase 2✓ In ChEMBL and the Guide to Pharmacology
- Epidermal growth factor receptor erbB1 inhibitor InhibitorTarget: EGFR epidermal growth factor receptor✓ In ChEMBL and the Guide to Pharmacology
- Esophageal adenocarcinomaPhase 3
- Gastric adenocarcinomaPhase 3
- Gastric cancerPhase 3
- Gastroesophageal junction adenocarcinomaPhase 3
- Head and neck squamous cell carcinomaPhase 3
- Soft tissue sarcomaPhase 3
- Triple-negative breast carcinomaPhase 3
- Breast adenocarcinomaPhase 2/3
- NF2-related schwannomatosisPhase 2
- Adenoid cystic carcinomaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL554, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 5692, 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 Lapatinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Lapatinib. 1 is current.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Lapatinib or trastuzumab in combination with an aromatase inhibitor for the first-line treatment of metastatic hormone receptor-positive breast cancer that overexpresses HER2 NICE TA257 | Not recommended | 27 Jun 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 Lapatinib
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: TyverbEMA 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 Lapatinib
- ATC code
- L01XE07
- ChEMBL
- CHEMBL554
- DrugBank
- DB01259
- PubChem CID
- 208908
- CAS number
- 231277-92-2
- FDA UNII
- 0VUA21238F
- Wikidata
- Q420323
- Wikipedia
- Lapatinib
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 Lapatinib
3 trials| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
A Phase Ⅲ Study of Hemay022 in Combination With AI In Advanced Breast Cancer
NCT06313983 · ClinicalTrials.gov ↗ · Breast Cancer
|
Phase 3 | Recruiting | Tianjin Hemay Pharmaceutical Co., Ltd | China |
|
Adapting Treatment to the Tumor Molecular Alterations for Patients With Advanced Solid Tumors: MyOwnSpecificTreatment
NCT02029001 · ClinicalTrials.gov ↗ · Malignant Solid Neoplasms
|
Phase 2 | Recruiting | Centre Leon Berard | France |
|
Antineoplastic Drugs in Elderly Patients
NCT05467189 · ClinicalTrials.gov ↗ · Cancer
|
Observational | Recruiting | Shandong University | China |
Registers 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 Lapatinib
3 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Tianjin Hemay Pharmaceutical Co., Ltd | 1 |
| Shandong University | 1 |
| Centre Leon Berard | 1 |
By country register
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in China | 2 | 2 |
| Clinical trials in France | 1 | 1 |
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Lapatinib trials
How many clinical trials are testing Lapatinib?
3 current trials in our China and France registers name Lapatinib as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Lapatinib trials recruiting patients?
Yes. 3 of the 3 trials are recruiting: 2 with sites in China and 1 with sites in France. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Lapatinib clinical trials?
Tianjin Hemay Pharmaceutical Co., Ltd (1), Shandong University (1) and Centre Leon Berard (1). 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 Lapatinib 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 Lapatinib 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 Lapatinib (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.