Primary completion· ClinicalTrials.gov
Neoadjuvant Lazertinib With or Without Chemotherapy for Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer
Lazertinib History and Updates
133 events · 2015 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: .
4
FDA Approvals
1
Label Revisions
128
Trial Milestones
0
Pivotal Publications
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-09Download chart as PNG
This page tracks every FDA action, clinical trial milestone, and major publication for Lazertinib since 2015, drawn from openFDA, ClinicalTrials.gov, and PubMed.
All published updates (3)
2026
- Label revisionLAZCLUZE Label Updated for First-Line NSCLC with EGFR Mutations· May 5, 2026
2025
- FDA approval (supplemental)Lazertinib Supplemental Application for Efficacy Approved by FDA· Aug 14, 2025
2022
- Primary completionLazertinib Extends PFS to 20.6 Months in EGFR+ NSCLC vs. Gefitinib· Jul 29, 2022
Upcoming & expected milestones
Trial started· ClinicalTrials.gov
A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC
Trial started· ClinicalTrials.gov
A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC
Primary completion· ClinicalTrials.gov
Lazertinib+Pemetrexed/Carboplatin in Patients With EGFR Sensitizing Mutation Positive Recurrent or Metastatic Non-Small Cell Lung Cancer Fai
Primary completion· ClinicalTrials.gov
A Randomized Phase II Study of LAZE rtiNib Alone Versus Lazertinib Plus bevaCizumab for NSCLC With EGFR + & Smoker
Primary completion· ClinicalTrials.gov
Lazertinib for NSCLC Harboring Activating EGFR Mutations in TKI naïve Patients
Primary completion· ClinicalTrials.gov
Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NS
Primary completion· ClinicalTrials.gov
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated No
Primary completion· ClinicalTrials.gov
A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC
Primary completion· ClinicalTrials.gov
To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-MET
Primary completion· ClinicalTrials.gov
A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal
Primary completion· ClinicalTrials.gov
Lazertinib & Tepotinib for EGFR Mutant NSCLC in MET Overexpressed or Amplified Who Progressed After Lazertinib Treatment
Primary completion· ClinicalTrials.gov
Collaborative Clinical-translational Cohort of Amivantamab Plus Lazertinib and Amivantamab Plus Chemotherapy in Patients With EGFR-mutant, L
Past events
2026
Primary completion· ClinicalTrials.gov
A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer
Trial registered· ClinicalTrials.gov
A Study of Neoadjuvant Amivantamab With Either Lazertinib or Chemotherapy in Participants With Resectable EGFR-Mutated NSCLC
Label revision· FDA
1 INDICATIONS AND USAGE LAZCLUZE, in combination with amivantamab, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGF
FDA approval (supplemental)· FDA
Sponsor: JANSSEN BIOTECH. Class: Labeling.
Trial started· ClinicalTrials.gov
Collaborative Clinical-translational Cohort of Amivantamab Plus Lazertinib and Amivantamab Plus Chemotherapy in Patients With EGFR-mutant, L
Trial registered· ClinicalTrials.gov
Collaborative Clinical-translational Cohort of Amivantamab Plus Lazertinib and Amivantamab Plus Chemotherapy in Patients With EGFR-mutant, L
Primary completion· ClinicalTrials.gov
A Study of Lazertinib as Consolidation Therapy in Patients With Locally Advanced, Unresectable, EGFR-Mutant Non-Small Cell Lung Cancer (Stag
Results posted· ClinicalTrials.gov
A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Recep
Primary completion· ClinicalTrials.gov
Amivantamab, Lazertinib, and Pemetrexed for First-line Treatment of Recurrent/Metastatic Non-small Cell Lung Cancers With Epidermal Growth F
2025
Primary completion· ClinicalTrials.gov
The Safety and Efficacy of First-line Lazertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR-mutant
Primary completion· ClinicalTrials.gov
Impact of Lazertinib Dose Modification on Effectiveness and Safety
Primary completion· ClinicalTrials.gov
A Study of Amivantamab and Lazertinib in People With Non-Small Cell Lung Cancer (NSCLC)
FDA approval (supplemental)· FDA
Sponsor: JANSSEN BIOTECH. Class: Labeling.
Results posted· ClinicalTrials.gov
Premedication to Reduce Amivantamab Associated Infusion Related Reactions
FDA approval (supplemental)· FDA
Sponsor: JANSSEN BIOTECH. Class: Efficacy.
Results posted· ClinicalTrials.gov
A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients
2024
Primary completion· ClinicalTrials.gov
Lazertinib for Patients With NSCLC Harboring Uncommon EGFR Mutations
Trial started· ClinicalTrials.gov
A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal
Trial registered· ClinicalTrials.gov
A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal
Results posted· ClinicalTrials.gov
A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
Lazertinib and Chemotherapy Combination in EGFR-mutant NSCLC Patients Without ctDNA Clearance After lead-in Lazertinib Monotherapy
Primary completion· ClinicalTrials.gov
Amivantamab, Lazertinib and Bevacizumab in Patients With EGFR-mutant Advanced Non-small Cell Lung Cancer With Progression on Previous Third-
FDA approval· FDA
Sponsor: JANSSEN BIOTECH. Class: Type 1 - New Molecular Entity.
Primary completion· ClinicalTrials.gov
Lazertinib in Patients With NSCLC With Asymptomatic or Mild Symptomatic Brain Metastases After Failure of EGFR TKI.
Primary completion· ClinicalTrials.gov
Lazertinib Real-world Observational Study of in Pre-treated EGFR T790M Mutant With Advanced Non-small Cell Lung Cancer
Trial started· ClinicalTrials.gov
Lazertinib & Tepotinib for EGFR Mutant NSCLC in MET Overexpressed or Amplified Who Progressed After Lazertinib Treatment
Primary completion· ClinicalTrials.gov
Neoadjuvant Lazertinib Therapy in EGFR-Mutation Positive Lung Adenocarcinoma Detected by BALF Liquid Biopsy
Primary completion· ClinicalTrials.gov
Premedication to Reduce Amivantamab Associated Infusion Related Reactions
Results posted· ClinicalTrials.gov
Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSC
Results posted· ClinicalTrials.gov
A Study of Lazertinib in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Positive Advanced Non-Small Cell Lung Cancer (NS
Trial registered· ClinicalTrials.gov
Neoadjuvant Lazertinib With or Without Chemotherapy for Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer
Trial started· ClinicalTrials.gov
Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NS
Primary completion· ClinicalTrials.gov
Lazertinib 160mg in EGFR T790M NSCLC
Primary completion· ClinicalTrials.gov
A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Recep
2023
Trial registered· ClinicalTrials.gov
A Randomized Phase II Study of LAZE rtiNib Alone Versus Lazertinib Plus bevaCizumab for NSCLC With EGFR + & Smoker
Trial registered· ClinicalTrials.gov
Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NS
Trial registered· ClinicalTrials.gov
Lazertinib & Tepotinib for EGFR Mutant NSCLC in MET Overexpressed or Amplified Who Progressed After Lazertinib Treatment
Trial started· ClinicalTrials.gov
Lazertinib and Chemotherapy Combination in EGFR-mutant NSCLC Patients Without ctDNA Clearance After lead-in Lazertinib Monotherapy
Trial started· ClinicalTrials.gov
A Randomized Phase II Study of LAZE rtiNib Alone Versus Lazertinib Plus bevaCizumab for NSCLC With EGFR + & Smoker
Trial registered· ClinicalTrials.gov
Lazertinib and Chemotherapy Combination in EGFR-mutant NSCLC Patients Without ctDNA Clearance After lead-in Lazertinib Monotherapy
Primary completion· ClinicalTrials.gov
A Study of Lazertinib (JNJ-73841937) Tablet in Healthy Adult Participants
Primary completion· ClinicalTrials.gov
A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients
Primary completion· ClinicalTrials.gov
Lazertinib/Pemetrexed/Carboplatin After Osimertinib Failure in NSCLC With Brain Metastases
Trial registered· ClinicalTrials.gov
A Study of Lazertinib (JNJ-73841937) Tablet in Healthy Adult Participants
Trial started· ClinicalTrials.gov
A Study of Lazertinib (JNJ-73841937) Tablet in Healthy Adult Participants
Trial started· ClinicalTrials.gov
Amivantamab, Lazertinib, and Pemetrexed for First-line Treatment of Recurrent/Metastatic Non-small Cell Lung Cancers With Epidermal Growth F
Trial started· ClinicalTrials.gov
Premedication to Reduce Amivantamab Associated Infusion Related Reactions
Trial registered· ClinicalTrials.gov
Retrospective, External Comparator Study of Lazertinib as the 2nd-Line Treatment in Patients With EGFR Mutation+ NSCLC
Trial started· ClinicalTrials.gov
Lazertinib+Pemetrexed/Carboplatin in Patients With EGFR Sensitizing Mutation Positive Recurrent or Metastatic Non-Small Cell Lung Cancer Fai
Primary completion· ClinicalTrials.gov
A Study of Four Different Oral Tablet Formulations of Lazertinib (JNJ-73841937) in Healthy Adult Participants
Trial started· ClinicalTrials.gov
Amivantamab, Lazertinib and Bevacizumab in Patients With EGFR-mutant Advanced Non-small Cell Lung Cancer With Progression on Previous Third-
Trial registered· ClinicalTrials.gov
Lazertinib+Pemetrexed/Carboplatin in Patients With EGFR Sensitizing Mutation Positive Recurrent or Metastatic Non-Small Cell Lung Cancer Fai
Trial registered· ClinicalTrials.gov
A Study of Four Different Oral Tablet Formulations of Lazertinib (JNJ-73841937) in Healthy Adult Participants
Trial registered· ClinicalTrials.gov
Impact of Lazertinib Dose Modification on Effectiveness and Safety
Trial started· ClinicalTrials.gov
Impact of Lazertinib Dose Modification on Effectiveness and Safety
Trial started· ClinicalTrials.gov
Lazertinib 160mg in EGFR T790M NSCLC
Trial registered· ClinicalTrials.gov
Lazertinib 160mg in EGFR T790M NSCLC
Trial started· ClinicalTrials.gov
To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-MET
Trial started· ClinicalTrials.gov
Lazertinib for NSCLC Harboring Activating EGFR Mutations in TKI naïve Patients
Trial started· ClinicalTrials.gov
A Study of Four Different Oral Tablet Formulations of Lazertinib (JNJ-73841937) in Healthy Adult Participants
2022
Trial registered· ClinicalTrials.gov
Premedication to Reduce Amivantamab Associated Infusion Related Reactions
Trial started· ClinicalTrials.gov
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated No
Trial registered· ClinicalTrials.gov
Amivantamab, Lazertinib and Bevacizumab in Patients With EGFR-mutant Advanced Non-small Cell Lung Cancer With Progression on Previous Third-
Trial registered· ClinicalTrials.gov
To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-MET
Trial started· ClinicalTrials.gov
Lazertinib/Pemetrexed/Carboplatin After Osimertinib Failure in NSCLC With Brain Metastases
Trial registered· ClinicalTrials.gov
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated No
Trial started· ClinicalTrials.gov
A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Recep
Trial started· ClinicalTrials.gov
Lazertinib Real-world Observational Study of in Pre-treated EGFR T790M Mutant With Advanced Non-small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSC
Trial registered· ClinicalTrials.gov
Lazertinib/Pemetrexed/Carboplatin After Osimertinib Failure in NSCLC With Brain Metastases
Trial registered· ClinicalTrials.gov
Neoadjuvant Lazertinib Therapy in EGFR-Mutation Positive Lung Adenocarcinoma Detected by BALF Liquid Biopsy
Trial registered· ClinicalTrials.gov
Lazertinib for NSCLC Harboring Activating EGFR Mutations in TKI naïve Patients
Primary completion· ClinicalTrials.gov
A Study to Evaluate the Effect of Hepatic Impairment on Lazertinib (JNJ-73841937)
Trial started· ClinicalTrials.gov
A Study of Lazertinib as Consolidation Therapy in Patients With Locally Advanced, Unresectable, EGFR-Mutant Non-Small Cell Lung Cancer (Stag
Trial registered· ClinicalTrials.gov
A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Recep
Trial started· ClinicalTrials.gov
Neoadjuvant Lazertinib Therapy in EGFR-Mutation Positive Lung Adenocarcinoma Detected by BALF Liquid Biopsy
Trial registered· ClinicalTrials.gov
Lazertinib Real-world Observational Study of in Pre-treated EGFR T790M Mutant With Advanced Non-small Cell Lung Cancer
Trial started· ClinicalTrials.gov
Lazertinib for Patients With NSCLC Harboring Uncommon EGFR Mutations
Primary completion· ClinicalTrials.gov
Retrospective, External Comparator Study of Lazertinib as the 2nd-Line Treatment in Patients With EGFR Mutation+ NSCLC
Trial registered· ClinicalTrials.gov
A Study of Lazertinib as Consolidation Therapy in Patients With Locally Advanced, Unresectable, EGFR-Mutant Non-Small Cell Lung Cancer (Stag
Trial registered· ClinicalTrials.gov
Lazertinib in Patients With NSCLC With Asymptomatic or Mild Symptomatic Brain Metastases After Failure of EGFR TKI.
Trial registered· ClinicalTrials.gov
Amivantamab, Lazertinib, and Pemetrexed for First-line Treatment of Recurrent/Metastatic Non-small Cell Lung Cancers With Epidermal Growth F
Trial registered· ClinicalTrials.gov
Lazertinib for Patients With NSCLC Harboring Uncommon EGFR Mutations
Primary completion· ClinicalTrials.gov
A Study of Lazertinib (JNJ-73841937) in Healthy Participants
Trial started· ClinicalTrials.gov
Neoadjuvant Lazertinib With or Without Chemotherapy for Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
Clinical Trial to Assess Bioequivalence of Lazertinib Between Two Formulations in Healthy Volunteers.
2021
Trial started· ClinicalTrials.gov
The Safety and Efficacy of First-line Lazertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR-mutant
Trial registered· ClinicalTrials.gov
The Safety and Efficacy of First-line Lazertinib and Locally Ablative Radiotherapy in Patients With Synchronous Oligo-metastatic EGFR-mutant
Trial registered· ClinicalTrials.gov
Clinical Trial to Assess Bioequivalence of Lazertinib Between Two Formulations in Healthy Volunteers.
Trial started· ClinicalTrials.gov
Clinical Trial to Assess Bioequivalence of Lazertinib Between Two Formulations in Healthy Volunteers.
Trial started· ClinicalTrials.gov
A Study to Evaluate the Effect of Hepatic Impairment on Lazertinib (JNJ-73841937)
Trial started· ClinicalTrials.gov
A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients
Trial registered· ClinicalTrials.gov
A Study to Evaluate the Effect of Hepatic Impairment on Lazertinib (JNJ-73841937)
Trial registered· ClinicalTrials.gov
A Study of Lazertinib (JNJ-73841937) in Healthy Participants
Trial started· ClinicalTrials.gov
A Study of Amivantamab and Lazertinib in People With Non-Small Cell Lung Cancer (NSCLC)
Trial started· ClinicalTrials.gov
A Study of Lazertinib (JNJ-73841937) in Healthy Participants
Trial registered· ClinicalTrials.gov
A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients
Trial registered· ClinicalTrials.gov
A Study of Amivantamab and Lazertinib in People With Non-Small Cell Lung Cancer (NSCLC)
Trial started· ClinicalTrials.gov
Lazertinib in Patients With NSCLC With Asymptomatic or Mild Symptomatic Brain Metastases After Failure of EGFR TKI.
Trial registered· ClinicalTrials.gov
Early Access Program of Lazertinib in Republic of Korea
Primary completion· ClinicalTrials.gov
A Study of (14C)-JNJ-73841937 (Lazertinib) in Healthy Male Participants
Primary completion· ClinicalTrials.gov
A Study of Lazertinib in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Positive Advanced Non-Small Cell Lung Cancer (NS
2020
Primary completion· ClinicalTrials.gov
A Study to Assess the Effects of Itraconazole and Rifampin on Lazertinib in Healthy Adult Participants
Trial started· ClinicalTrials.gov
A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Trial started· ClinicalTrials.gov
A Study to Assess the Effects of Itraconazole and Rifampin on Lazertinib in Healthy Adult Participants
Trial registered· ClinicalTrials.gov
A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Trial started· ClinicalTrials.gov
A Study of (14C)-JNJ-73841937 (Lazertinib) in Healthy Male Participants
Trial registered· ClinicalTrials.gov
A Study to Assess the Effects of Itraconazole and Rifampin on Lazertinib in Healthy Adult Participants
Trial registered· ClinicalTrials.gov
A Study of (14C)-JNJ-73841937 (Lazertinib) in Healthy Male Participants
Trial started· ClinicalTrials.gov
Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSC
Trial registered· ClinicalTrials.gov
Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSC
2019
Trial started· ClinicalTrials.gov
A Study of Lazertinib in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Positive Advanced Non-Small Cell Lung Cancer (NS
Trial registered· ClinicalTrials.gov
A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer
Trial started· ClinicalTrials.gov
A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer
Trial registered· ClinicalTrials.gov
A Study of Lazertinib in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Positive Advanced Non-Small Cell Lung Cancer (NS
2016
Trial started· ClinicalTrials.gov
Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer
2015
Trial registered· ClinicalTrials.gov
Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer
Trial started· ClinicalTrials.gov
Retrospective, External Comparator Study of Lazertinib as the 2nd-Line Treatment in Patients With EGFR Mutation+ NSCLC
Sources
FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.