Lazertinib clinical trials
Lazertinib is named as an intervention in 15 current clinical trials in our South Korea, USA, Spain, France, China, Taiwan, Germany, Italy, UK, Japan, Israel, Canada, Brazil, Poland, Portugal, Turkey, Belgium, Mexico, Netherlands, Australia, Egypt, India, Sweden, Denmark, Czechia and Switzerland registers. 6 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Janssen Research & Development, LLC (10). The most-studied condition is Carcinoma, Non-Small-Cell Lung. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
Where Lazertinib is approved
All regulators →Of the three regulators tracked here, the first to approve Lazertinib was the US, on 19 Aug 2024. It is approved in 3 of the 3 regulators tracked here.
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.
Lazertinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Lazertinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 9 listed patents; the last listed expires 1 Aug 2041 (US 11850248).
- Latest patent on the drug substance itself: 18 Apr 2038 (US 11453656).
- Exclusivity NCE: New chemical entity, until 19 Aug 2029.
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Lazertinib
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 Lazertinib works
All drug targets →- Epidermal growth factor receptor erbB1 inhibitor InhibitorTarget: EGFR epidermal growth factor receptor✓ In ChEMBL and the Guide to Pharmacology
- Lung adenocarcinomaPhase 2
- Lung cancerPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4558324, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 10136, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Lazertinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 2 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: LazcluzeEMA 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.
Trials by status
Trials by phase
Clinical trials of Lazertinib
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.
Lazertinib in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Lazertinib. 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 |
|---|---|---|---|---|
|
DYNAMIC ” IDentifY the best therapeutic sequeNcing strAtegy in oncogene addICted NSCLC:”
“A multi-arms prospective, randomized phase II study to evaluate the best sequential
therapeutic strategis in patients with metastatic non-small cell lung cancer harboring
targetable genomic driver alterations”
2026-525268-16-00 · CTIS ↗ · Neoplasms
|
Phase 3 | Authorised | Universita' Degli Studi Di Torino | Italy |
|
A Phase 2 Study Evaluating the Safety and Efficacy of Neoadjuvant Amivantamab in Combination with Lazertinib or Chemotherapy in Resectable EGFR-Mutated Non-Small Cell Lung Cancer
2025-524816-13-00 · Neoplasms
|
Phase 2 | Ongoing | Janssen Cilag International | Spain |
Lazertinib 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)
2 single-substance products containing Lazertinib on the HPRA medicines list.
- Lazcluze 240 mg film-coated tabletsJanssen-Cilag International NV · EU/1/24/1886/004-006
- Lazcluze 80 mg film-coated tabletsJanssen-Cilag International NV · EU/1/24/1886/001-003
Supply shortages
No entry for Lazertinib in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Lazertinib
9 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Janssen Research & Development, LLC | 10 |
| Abion Inc | 1 |
| ETOP IBCSG Partners Foundation | 1 |
| National Cancer Center, Korea | 1 |
| Yonsei University | 1 |
| Sehhoon Park | 1 |
By 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 Lazertinib trials
How many clinical trials are testing Lazertinib?
15 current trials in our South Korea, USA, Spain, France, China, Taiwan, Germany, Italy, UK, Japan, Israel, Canada, Brazil, Poland, Portugal, Turkey, Belgium, Mexico, Netherlands, Australia, Egypt, India, Sweden, Denmark, Czechia and Switzerland registers name Lazertinib (also registered as JNJ-73841937) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Lazertinib trials recruiting patients?
Yes. 6 of the 15 trials are recruiting: 5 with sites in South Korea, 4 with sites in USA, 3 with sites in Spain, 2 with sites in France, 3 with sites in China, 2 with sites in Taiwan, 2 with sites in Germany, 2 with sites in Italy, 2 with sites in UK, 1 with sites in Japan, 2 with sites in Israel, 1 with sites in Canada, 1 with sites in Brazil, 1 with sites in Poland, 1 with sites in Portugal, 1 with sites in Belgium, 1 with sites in Mexico and 1 with sites in Egypt. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Lazertinib clinical trials?
Janssen Research & Development, LLC (10), Abion Inc (1), ETOP IBCSG Partners Foundation (1) and National Cancer Center, Korea (1), among 6 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Lazertinib licensed in Ireland?
Yes. The HPRA medicines list includes 2 single-substance products containing Lazertinib, for example Lazcluze 240 mg film-coated tablets (Janssen-Cilag International NV). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Lazertinib shortage?
Not in the lists we track: Lazertinib 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 Lazertinib 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 Lazertinib 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 Lazertinib (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.