Clinical Trials

Numerous clinical trials across Phase 1, Phase 2, and Phase 3 evaluate lazertinib, primarily focusing on EGFR-mutated metastatic non-small cell lung cancer (NSCLC) alongside pharmacokinetic assessments in healthy volunteers and subjects with hepatic impairment. Sponsored by pharmaceutical companies such as Yuhan Corporation and Janssen Research & Development alongside academic institutions like Samsung Medical Center, these studies range in status from active recruitment to completed and approved for marketing. Representative investigations encompass early-phase bioequivalence assessments as well as pivotal Phase 3 trials comparing lazertinib against standard EGFR inhibitors.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07507188 NOT_YET_RECRUITING
Non Small Cell Lung Cancer
Yonsei University
 2026-04-06 PHASE2
NCT06106802 RECRUITING
Non-Small Cell Lung Cancer Metastatic
Samsung Medical Center
 2024-06-11 PHASE2
NCT07774520 RECRUITING
Non-small Cell Lung Cancer(NSCLC); EGFR Mutant
Samsung Medical Center
 2026-05-26 PHASE2
NCT06667076 RECRUITING
Carcinoma, Non-Small-Cell Lung
Janssen Research & Development, LLC
 2024-12-16 PHASE2
NCT05541822 RECRUITING
Advanced Solid Tumors
Abion Inc
 2023-01-17 PHASE2
NCT06268210 ACTIVE_NOT_RECRUITING
Non-small Cell Lung Cancer
Yonsei University
 2022-02-07 PHASE2
NCT07586202 RECRUITING
Carcinoma, Non-Small-Cell Lung
Janssen Research & Development, LLC
 2026-07-28 PHASE2
NCT05498428 RECRUITING
Carcinoma, Non-small-Cell Lung
Janssen Research & Development, LLC
 2022-11-11 PHASE2
NCT06120140 ACTIVE_NOT_RECRUITING
Carcinoma, Non-Small-Cell Lung
Janssen Research & Development, LLC
 2024-02-16 PHASE2
NCT04077463 ACTIVE_NOT_RECRUITING
Carcinoma, Non-Small-Cell Lung
Janssen Research & Development, LLC
 2019-09-04 PHASE1
NCT02609776 ACTIVE_NOT_RECRUITING
Non-Small-Cell Lung Cancer
Janssen Research & Development, LLC
 2016-05-24 PHASE1
NCT05463224 ACTIVE_NOT_RECRUITING
NSCLC
Sehhoon Park
 2023-01-04 PHASE2
NCT06156527 RECRUITING
Lazertinib
National Cancer Center, Korea
 2023-09-05 PHASE2
NCT05786430 ACTIVE_NOT_RECRUITING
Non-small Cell Lung Cancer
Yonsei University
 2023-04-07 PHASE2
NCT05338619 UNKNOWN
Non-small Cell Lung Cancer Stage III; EGFR Positive Non-small Cell Lung Cancer; Non-squamous Non-small-cell Lung Cancer
Sung Yong Lee
 2022-06-30 PHASE2
NCT04965090 COMPLETED
Metastatic Non Small Cell Lung Cancer; Recurrent Non Small Cell Lung Cancer
Memorial Sloan Kettering Cancer Center
 2021-09-30 PHASE2
NCT05167851 UNKNOWN
Non Small Cell Lung Cancer
Yonsei University
 2021-12 PHASE2
NCT05277701 UNKNOWN
NSCLC
Yonsei University
 2022-04 PHASE2
NCT06020989 UNKNOWN
Non Small Cell Lung Cancer
Yonsei University
 2023-09 PHASE2
NCT05601973 ACTIVE_NOT_RECRUITING
Non Small Cell Lung Cancer
ETOP IBCSG Partners Foundation
 2023-03-27 PHASE2
NCT05299125 COMPLETED
Metastatic Non-small Cell Lung Cancers
Latin American Cooperative Oncology Group
 2023-05-24 PHASE2
NCT05326425 UNKNOWN
Lung Neoplasms
Jin Hyoung Kang
 2021-06-23 PHASE2
NCT05469022 RECRUITING
Non Small Cell Lung Cancer
Konkuk University Medical Center
 2022-05-19 PHASE2
NCT05663866 ACTIVE_NOT_RECRUITING
Carcinoma, Non-Small-Cell Lung
Janssen Research & Development, LLC
 2023-05-18 PHASE2
NCT05701384 UNKNOWN
Lung Cancer Stage IV; EGFR T790M
Samsung Medical Center
 2023-02-01 PHASE2
NCT05388669 ACTIVE_NOT_RECRUITING
Advanced or Metastatic Non-small Cell Lung Cancer
Janssen Research & Development, LLC
 2022-08-05 PHASE3
NCT05896683 COMPLETED
Healthy
Janssen Research & Development, LLC
 2023-05-30 PHASE1
NCT04487080 ACTIVE_NOT_RECRUITING
Carcinoma, Non-Small-Cell Lung
Janssen Research & Development, LLC
 2020-09-30 PHASE3
NCT04988295 ACTIVE_NOT_RECRUITING
Carcinoma, Non-Small-Cell Lung
Janssen Research & Development, LLC
 2021-11-17 PHASE3
NCT05477615 UNKNOWN
Non-small Cell Lung Cancer
Jin Hyoung Kang
 2022-08 PHASE2
NCT05896683 Completed
Healthy
Janssen Research & Development LLC
 2023-05-30 Phase 1
NCT05742594 COMPLETED
Healthy
Janssen Research & Development, LLC
 2023-01-03 PHASE1
NCT05601973 Recruiting
Non Small Cell Lung Cancer
ETOP IBCSG Partners Foundation|Janssen Pharmaceuticals
 2023-03-27 Phase 2
NCT05742594 Completed
Healthy
Janssen Research & Development LLC
 2023-01-03 Phase 1
NCT04248829 COMPLETED
Non-Small Cell Lung Cancer
Yuhan Corporation
 2020-02-13 PHASE3
NCT05112952 COMPLETED
Hepatic Impairment; Healthy
Janssen Research & Development, LLC
 2021-11-30 PHASE1
NCT05076877 COMPLETED
Healthy
Janssen Research & Development, LLC
 2021-09-17 PHASE1
NCT05162274 COMPLETED
Healthy Adult Volunteers
Yuhan Corporation
 2021-11-30 PHASE1
NCT05162274 Completed
Healthy Adult Volunteers
Yuhan Corporation
 2021-11-30 Phase 1
NCT05112952 Completed
Hepatic Impairment|Healthy
Janssen Research & Development LLC
 2021-11-30 Phase 1
NCT04410081 COMPLETED
Healthy
Janssen Research & Development, LLC
 2020-07-14 PHASE1
NCT04075396 COMPLETED
Carcinoma, Non-Small-Cell Lung
Janssen Research & Development, LLC
 2019-10-16 PHASE1; PHASE2
NCT04410094 COMPLETED
Healthy
Janssen Research & Development, LLC
 2020-09-14 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-04-02)

Check the Lazertinib (YH25448) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lazertinib is a potent, irreversible, and mutant-selective epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor that selectively binds to mutated EGFR forms—including Del19, L858R, and T790M resistance mutations—thereby blocking receptor autophosphorylation and downstream oncogenic signaling cascades. By suppressing cell proliferation and inducing apoptosis in cancer cells driven by mutant EGFR while sparing wild-type receptor activity, lazertinib effectively inhibits tumor growth in patients with advanced or metastatic EGFR-mutant non-small cell lung cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.