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 6 indications, with its most advanced program in Approved.[1]

Lazcluze is one of 197 small molecule programs targeting Lung Cancer. It is currently in Approved.

Indications

Total Trials

Active Trials

196

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 CancerCompleted

BevacizumabRecruiting

Patients With Advanced Solid TumorsRecruiting

Lung CancerApproved

Active, not recruiting

Lung NeoplasmApproved

Approved

Liver DiseaseApproved

Approved

Non-Small Cell Lung CancerPhase 3

Completed

BevacizumabPhase 2

Recruiting

Patients With Advanced Solid TumorsPhase 2

Recruiting

Competition

Competitive Landscape

414 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Lazcluze

Johnson & Johnson

Approved

9 2

Sacituzumab Tirumotecan

Merck & Co.

Phase 3

5 3

SKB264

SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Phase 3

5 4

HS-20093

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Phase 3

2 5

Remeron

OOrganon and Co

Preclinical

1 6

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—7

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—8

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

1 10

PD-1 Inhibitors

BBioNTech US Inc.

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Bevacizumab

NCT06156527

Q2 2027

Phase 3Active, not recruiting

Advanced or Metastatic Non-Small Cell Lung Cancer

NCT05388669

Q3 2027

Phase 2Active, not recruiting

Carcinoma, Non-Small-Cell Lung

NCT05663866

Q4 2027

Phase 1Active, not recruiting

Non-Small Cell Lung Cancer

NCT02609776

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer9 trials

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

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

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

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

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

Phase II Trial of Lazertinib and Pemetrexed/Carboplatin Combination in Patients With EGFR Positive, Metastatic NSCLC With Asymptomatic or Mild Symptomatic Brain Metastases After Failure of Osimertinib

Terminated·JJin Hyoung Kang·Phase 2·NCT05477615·14 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 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 Lung8 trials

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

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 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 5 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

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

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 3, Open-Label, Randomized Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With 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

Adult3 trials

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

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

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

13 more indications

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

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

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

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

ART1 trial

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

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05076877·20 enrolled

Brain Metastases1 trial

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

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

Uncommon EGFR Mutations1 trial

Lazertinib for Patients With NSCLC Harboring Uncommon EGFR Mutations

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

NSCLC1 trial

Lazertinib 160mg in EGFR T790M NSCLC

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

Non Small Cell Lung Cancer Metastatic1 trial

Lazertinib and Tepotinib for EGFR Mutant NSCLC in MET Overexpressed or Amplified Who Progressed After Lazertinib Treatment: A Phase II Multi-center Trial

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

Non-small Cell Lung Cancers1 trial

A Single Arm, Phase 2 Study of Amivantamab, Lazertinib and Pemetrexed for First-line Treatment of Recurrent/Metastatic Non-small Cell Lung Cancers (NSCLCs) With EGFR Mutations

Completed·LLatin American Cooperative Oncology Group·Phase 2·NCT05299125·54 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

RE50528Oct 13, 2035

9593098Oct 13, 2035

11453656Apr 18, 2038

11981659Apr 18, 2038

12318390Apr 18, 2038

4 more patents

12599606May 14, 2040

11879013May 21, 2040

12138351Apr 13, 2041

11850248Aug 1, 2041

Lazcluze

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Non-Small Cell Lung Cancer9 trials

Carcinoma, Non-Small-Cell Lung8 trials

Adult3 trials

Effectiveness1 trial

Bevacizumab1 trial

Patients With Advanced Solid Tumors1 trial

Chemotherapy1 trial

Hepatic Impairment1 trial

EGFR Mutation1 trial

ART1 trial

Brain Metastases1 trial

Clinical Trial1 trial

ESS1 trial

Uncommon EGFR Mutations1 trial

NSCLC1 trial

Advanced or Metastatic Non-small Cell Lung Cancer1 trial

Non Small Cell Lung Cancer Metastatic1 trial

Non-small Cell Lung Cancers1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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