Lazertinib

Overview

Lazertinib is under investigation in clinical trial NCT04487080 (A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-small Cell Lung Cancer).

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)	2024/10/31	NCT06667076	Phase 2	Recruiting	Janssen Research & Development, LLC
Neoadjuvant Lazertinib With or Without Chemotherapy for Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer	2024/02/20	NCT06268210	Phase 2	Not yet recruiting	Yonsei University
A Randomized Phase II Study of LAZE rtiNib Alone Versus Lazertinib Plus bevaCizumab for NSCLC With EGFR + & Smoker	2023/12/05	NCT06156527	Phase 2	Recruiting	National Cancer Center, Korea
Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib	2023/11/07	NCT06120140	Phase 2	Recruiting	Janssen Research & Development, LLC
Lazertinib & Tepotinib for EGFR Mutant NSCLC in MET Overexpressed or Amplified Who Progressed After Lazertinib Treatment	2023/10/30	NCT06106802	Phase 2	Not yet recruiting	Samsung Medical Center
Lazertinib and Chemotherapy Combination in EGFR-mutant NSCLC Patients Without ctDNA Clearance After lead-in Lazertinib Monotherapy	2023/09/01	NCT06020989	Phase 2	Not yet recruiting	Yonsei University
A Study of Lazertinib (JNJ-73841937) Tablet in Healthy Adult Participants	2023/06/09	NCT05896683	Phase 1	Completed	Janssen Research & Development, LLC
Retrospective, External Comparator Study of Lazertinib as the 2nd-Line Treatment in Patients With EGFR Mutation+ NSCLC	2023/05/17	NCT05862194	N/A	Completed	Yuhan Corporation
A Study of Four Different Oral Tablet Formulations of Lazertinib (JNJ-73841937) in Healthy Adult Participants	2023/02/24	NCT05742594	Phase 1	Completed	Janssen Research & Development, LLC
Impact of Lazertinib Dose Modification on Effectiveness and Safety	2023/02/08	NCT05716672	N/A	Not yet recruiting	Pusan National University Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Lazcluze	Janssen Cilag International NV,Turnhoutseweg 30,B 2340 Beerse,Belgium	Authorised	1/20/2025
Lazcluze	Janssen Cilag International NV,Turnhoutseweg 30,B 2340 Beerse,Belgium	Authorised	1/20/2025

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
LAZCLUZE lazertinib 80 mg film-coated tablets blister pack	444772	Janssen-Cilag Pty Ltd	Medicine	A	4/15/2025
LAZCLUZE lazertinib 240 mg film-coated tablets bottle	444771	Janssen-Cilag Pty Ltd	Medicine	A	4/15/2025
LAZCLUZE lazertinib 240 mg film-coated tablets blister pack	444770	Janssen-Cilag Pty Ltd	Medicine	A	4/15/2025
LAZCLUZE lazertinib 80 mg film-coated tablets bottle	444773	Janssen-Cilag Pty Ltd	Medicine	A	4/15/2025

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
LAZCLUZE 240 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Janssen-Cilag International N.V	1241886005	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Not Commercialized
LAZCLUZE 80 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Janssen-Cilag International N.V	1241886001	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

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