Lazcluze

(Lazertinib)

ApprovedSmall molecule

Lazcluze is a small molecule that works as a Epidermal Growth Factor Receptor Erbb1 Inhibitor; Epidermal Growth Factor Receptor Erbb1 Inhibitor.[2] It is being used across 8 indications, with its most advanced program in Approved.[1]

Lazcluze is one of 202 small molecule programs targeting Lung Cancer. It is currently in Approved.

Indications

Total Trials

Active Trials

201

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Lung CancerActive, not recruiting

Lung NeoplasmApproved

Liver DiseaseApproved

Non-Small Cell Lung CancerActive, not recruiting

Hepatocellular CarcinomaActive, not recruiting

Small Cell Lung CancerActive, not recruiting

Advanced or Metastatic Non-Small Cell Lung CancerActive, not recruiting

Carcinoma, Non-Small-Cell LungActive, not recruiting

Lung CancerApproved

Active, not recruiting

Lung NeoplasmApproved

Approved

Liver DiseaseApproved

Approved

Non-Small Cell Lung CancerPhase 3

Active, not recruiting

Hepatocellular CarcinomaPhase 3

Active, not recruiting

Small Cell Lung CancerPhase 3

Active, not recruiting

Advanced or Metastatic Non-Small Cell Lung CancerPhase 3

Active, not recruiting

Carcinoma, Non-Small-Cell LungPhase 3

Active, not recruiting

Competition

Competitive Landscape

1639 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Lazcluze

Johnson & Johnson

Approved

9 2

Gemzar

GGynecologic Oncology Group

Preclinical

72 3

PORTRAZZA

Eli Lilly

Preclinical

8 4

Lenvima

Eisai

Preclinical

6 5

Vizimpro

Pfizer

Preclinical

4 6

Ofev

Boehringer Ingelheim

Preclinical

7 7

Immunotherapy

Bristol-Myers Squibb

Preclinical

12 8

PD-1 Inhibitor

Johnson & Johnson

Preclinical

2 9

Tyrosine Kinase Inhibitor

Pfizer

Preclinical

2 10

REGN2810

Regeneron

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 3Active, not recruiting

Small Cell Lung Cancer

NCT04988295

Phase 2Active, not recruiting

Non-Small Cell Lung Cancer

NCT05601973

Q4 2026

Phase 2Recruiting

Bevacizumab

NCT06156527

Phase 1Active, not recruiting

Non-Small Cell Lung Cancer

NCT02609776

Q1 2027

Phase 2Active, not recruiting

Carcinoma, Non-Small-Cell Lung

NCT05663866

Q2 2027

Phase 3Active, not recruiting

Advanced or Metastatic Non-Small Cell Lung Cancer

NCT05388669

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer9 trials

Lazertinib Real-world Observational Study of in Pre-treated EGFR T790M Mutant With Advanced Non-small Cell Lung Cancer

Unknown status·SSamsung Medical Center··NCT05377788·900 enrolled

Amivantamab, Lazertinib, and Pemetrexed for First-line Treatment of Recurrent/Metastatic Non-small Cell Lung Cancers With Epidermal Growth Factor Receptor Mutations

Active, not recruiting·LLatin American Cooperative Oncology Group·Phase 2·NCT05299125·54 enrolled

A Study of Amivantamab and Lazertinib in People With Non-Small Cell Lung Cancer (NSCLC)

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04965090·43 enrolled

Show 6 more trials

A Study of Lazertinib as Consolidation Therapy in Patients With Locally Advanced, Unresectable, EGFR-Mutant Non-Small Cell Lung Cancer (Stage III) Following Chemoradiation Therapy

Unknown status·SSung Yong Lee·Phase 2·NCT05338619·77 enrolled

Amivantamab, Lazertinib and Bevacizumab in Patients With EGFR-mutant Advanced Non-small Cell Lung Cancer With Progression on Previous Third-generation EGFR-TKI

Active, not recruiting·EETOP IBCSG Partners Foundation·Phase 2·NCT05601973·60 enrolled

A Study of Lazertinib in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC)

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1/2·NCT04075396·29 enrolled

Neoadjuvant Lazertinib With or Without Chemotherapy for Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer (NeoLazer): a Phase II, Randomized, Multi-center Study

Active, not recruiting·YYonsei University·Phase 2·NCT06268210·160 enrolled

A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Subjects With Advanced Non-Small Cell Lung Cancer

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02609776·751 enrolled

A Phase III, Randomized, Double-blind Study to Assess the Efficacy and Safety of Lazertinib Versus Gefitinib as the First-line Treatment in Patients With Epidermal Growth Factor Receptor Sensitizing Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Completed·YYuhan Corporation·Phase 3·NCT04248829·393 enrolled

Carcinoma, Non-Small-Cell Lung7 trials

A Phase 3, Randomized Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer.

Active, not recruiting· Roche logo

Roche·Phase 3·NCT04487080·1,074 enrolled

A Phase 2, Open-Label, Randomized Trial Evaluating the Impact of Enhanced Versus Standard Dermatologic Management on Selected Dermatologic Adverse Events Among Patients With Locally Advanced or Metastatic EGFR-Mutated NSCLC Treated First-Line With Amivantamab + Lazertinib

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT06120140·305 enrolled

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

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT07586202·68 enrolled

Show 4 more trials

A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination With Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination With Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT06667076·480 enrolled

An Open-label Phase 1/1b Study to Evaluate the Safety and Pharmacokinetics of JNJ-73841937 (Lazertinib), a Third Generation EGFR-TKI, as Monotherapy or in Combinations With JNJ-61186372, a Human Bispecific EGFR and cMet Antibody in Participants With Advanced Non-Small Cell Lung Cancer

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04077463·701 enrolled

Subcutaneous Methotrexate, Oral Dexamethasone or Oral Montelukast for the Prevention of Infusion Related Reaction Associated With Amivantamab, an EGFR-MET Bispecific Antibody, Among Post-osimertinib Treated EGFRm NSCLC; SKIPPirr, a Phase 2 Study

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT05663866·68 enrolled

A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients With Advanced or Metastatic Solid Tumors Including EGFR-mutated Non-Small Cell Lung Cancer

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT05498428·520 enrolled

Adult3 trials

A Study to Assess the Effects of Itraconazole and Rifampin on Lazertinib in Healthy Adult Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT04410094·32 enrolled

A Study of Four Different Oral Tablet Formulations of Lazertinib (JNJ-73841937) in Healthy Adult Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05742594·64 enrolled

A Study of Lazertinib (JNJ-73841937) Tablet in Healthy Adult Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05896683·72 enrolled

Brain Metastases2 trials

Lazertinib in Patients With NSCLC With Asymptomatic or Mild Symptomatic Brain Metastases After Failure of EGFR TKI.

Unknown status·JJin Hyoung Kang·Phase 2·NCT05326425·40 enrolled

Lazertinib/Pemetrexed/Carboplatin After Osimertinib Failure in NSCLC With Brain Metastases

Unknown status·JJin Hyoung Kang·Phase 2·NCT05477615·28 enrolled

EGFR Mutation1 trial

Retrospective, External Comparator Study of Lazertinib as the 2nd-Line Treatment in Patients With EGFR Mutation+ NSCLC

Completed·YYuhan Corporation··NCT05862194·534 enrolled

13 more indications

Uncommon EGFR Mutations1 trial

Lazertinib for Patients With NSCLC Harboring Uncommon EGFR Mutations

Unknown status·YYonsei University·Phase 2·NCT05277701·36 enrolled

Small Cell Lung Cancer1 trial

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT04988295·776 enrolled

NSCLC1 trial

Lazertinib 160mg in EGFR T790M NSCLC

Unknown status·SSamsung Medical Center·Phase 2·NCT05701384·117 enrolled

Hepatic Impairment1 trial

A Study to Evaluate the Effect of Hepatic Impairment on Lazertinib (JNJ-73841937)

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05112952·16 enrolled

Effectiveness1 trial

Impact of Lazertinib Dose Modification on Effectiveness and Safety

Unknown status·PPusan National University Hospital··NCT05716672·200 enrolled

Bevacizumab1 trial

A Randomized Phase II Study of LAZE rtiNib Alone Versus Lazertinib Plus bevaCizumab for NSCLC With EGFR + & Smoker

Recruiting·NNational Cancer Center, Korea·Phase 2·NCT06156527·120 enrolled

Treatment1 trial

Lazertinib & Tepotinib for EGFR Mutant NSCLC in MET Overexpressed or Amplified Who Progressed After Lazertinib Treatment

Recruiting·SSamsung Medical Center·Phase 2·NCT06106802·47 enrolled

Patients With Advanced Solid Tumors1 trial

To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-MET Dysregulation

Recruiting·AAbion Inc·Phase 2·NCT05541822·178 enrolled

Clinical Trial1 trial

Clinical Trial to Assess Bioequivalence of Lazertinib Between Two Formulations in Healthy Volunteers.

Completed·YYuhan Corporation·Phase 1·NCT05162274·38 enrolled

ESS1 trial

Early Access Program of Lazertinib in Republic of Korea

Approved for marketing·YYuhan Corporation··NCT04829422

Chemotherapy1 trial

Lazertinib and Chemotherapy Combination in EGFR-mutant NSCLC Patients Without ctDNA Clearance After lead-in Lazertinib Monotherapy

Unknown status·YYonsei University·Phase 2·NCT06020989·129 enrolled

ART1 trial

A Study of Lazertinib (JNJ-73841937) in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05076877·20 enrolled

Advanced or Metastatic Non-small Cell Lung Cancer1 trial

A Phase 3, Open-label, Randomized Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Patients With EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT05388669·418 enrolled

Regulatory

FDA Approval Timeline[4]

Aug 19, 2024

LAZCLUZE

NDA NDA219008

Sources

References

[1]
ClinicalTrials.gov — 35 trial records for Lazertinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Lazertinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Lazertinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA219008). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Lazcluze. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Johnson & Johnson company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Epidermal Growth Factor Receptor Erbb1 Inhibitor; Epidermal Growth Factor Receptor Erbb1 Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Johnson & Johnson

Patent Landscape[5]

Patent Cliff

Oct 13, 2035

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9593098Oct 13, 2035

11981659Apr 18, 2038

11453656Apr 18, 2038

12318390Apr 18, 2038

12599606May 14, 2040

3 more patents

11879013May 21, 2040

12138351Apr 13, 2041

11850248Aug 1, 2041

Lazcluze

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Non-Small Cell Lung Cancer9 trials

Carcinoma, Non-Small-Cell Lung7 trials

Adult3 trials

Brain Metastases2 trials

EGFR Mutation1 trial

Uncommon EGFR Mutations1 trial

Small Cell Lung Cancer1 trial

NSCLC1 trial

Hepatic Impairment1 trial

Effectiveness1 trial

Bevacizumab1 trial

Treatment1 trial

Patients With Advanced Solid Tumors1 trial

Clinical Trial1 trial

ESS1 trial

Chemotherapy1 trial

ART1 trial

Advanced or Metastatic Non-small Cell Lung Cancer1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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