Last update 16 Apr 2025

Lazertinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Lazertinib, Lazertinib (USAN), Lazertinib mesylate monohydrate
+ [14]
Action
inhibitors
Mechanism
EGFR exon 19 deletion inhibitors, EGFR exon 21 L858R mutation inhibitors
Inactive Indication
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
Regulation-
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Structure/Sequence

Molecular FormulaC31H40N8O7S
InChIKeyZJPNGZUERUYZEG-UHFFFAOYSA-N
CAS Registry2867596-18-5

External Link

KEGGWikiATCDrug Bank
D11980--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
EGFR-mutated non-small Cell Lung Cancer
Japan
27 Mar 2025
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer
United States
19 Aug 2024
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer
South Korea
18 Jan 2021
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma
South Korea
18 Jan 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Advanced Lung Non-Small Cell CarcinomaPhase 3
United States
05 Aug 2022
Advanced Lung Non-Small Cell CarcinomaPhase 3
China
05 Aug 2022
Advanced Lung Non-Small Cell CarcinomaPhase 3
Japan
05 Aug 2022
Advanced Lung Non-Small Cell CarcinomaPhase 3
Argentina
05 Aug 2022
Advanced Lung Non-Small Cell CarcinomaPhase 3
Australia
05 Aug 2022
Advanced Lung Non-Small Cell CarcinomaPhase 3
Brazil
05 Aug 2022
Advanced Lung Non-Small Cell CarcinomaPhase 3
Canada
05 Aug 2022
Advanced Lung Non-Small Cell CarcinomaPhase 3
France
05 Aug 2022
Advanced Lung Non-Small Cell CarcinomaPhase 3
Germany
05 Aug 2022
Advanced Lung Non-Small Cell CarcinomaPhase 3
Israel
05 Aug 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
EGFR-mutated non-small Cell Lung Cancer
First line
EGFR L858R | EGFR Exon 19 Deletion
-
acepcwnkas(dflhlwocrw) = qxiduggtpf fyidceqwjv (nmsqfkdrig, 42.9 - NE)
Positive
26 Mar 2025
acepcwnkas(dflhlwocrw) = vhschqhqnx fyidceqwjv (nmsqfkdrig, 33.4 - 41.0)
Phase 1
49
muuccavvmc(rwrdhufzde) = jkmvsscvir bghtgbkpte (gueektnxny )
Positive
26 Mar 2025
EGFR TKIs (Osimertinib, Afatinib)
muuccavvmc(rwrdhufzde) = iuuidulyqe bghtgbkpte (gueektnxny )
Phase 2
Lung Cancer
Neoadjuvant | Adjuvant
EGFR mutations
128
Neoadjuvant lazertinib therapy
lkfluurxbn(flwrvphdqo) = knngrhjwnc zfvaiiclhw (kkfygtyjbc )
Positive
26 Mar 2025
Phase 3
Non-Small Cell Lung Cancer
First line
EGFR Exon 19 Deletion | EGFR L858R
1,074
rvipitugxk(ghaanfshlt) = clinically meaningful and statistically significant improvement in OS versus the current standard of care osimertinib. Improvement in median OS is expected to exceed one year. zopzvmhpwi (jjywaembkp )
Met
Positive
07 Jan 2025
Phase 1
EGFR-mutated non-small Cell Lung Cancer
EGFR L858R | EGFR Exon 19 Deletion
162
Amivantamab 1050 mg + Lazertinib 240 mg
oopjassovy(cgiegopkiz) = pbdwvlqzjb jrpgiaqxln (kjlonkqbjb, 22 - 36)
Positive
02 Jan 2025
Phase 2
54
xzxvxqureo(nprfmvtdid) = egufvzlrml zrnubgedfr (wycfqlqzgt, 5.16 - 9.56)
Positive
07 Dec 2024
Phase 3
1,074
(Experimental: Arm A (Open-label): Amivantamab + Lazertinib)
jlkvzohgff(uzlwqwytlb) = kmfpuraqrv jaabafqgbg (sdmomucwfs, kskhhlpnpq - avnyquqrex)
-
09 Oct 2024
(Active Comparator: Arm B (Double-blind): Osimertinib+Placebo Matching Lazertinib)
jlkvzohgff(uzlwqwytlb) = qomqhnoyuz jaabafqgbg (sdmomucwfs, sjogpxuyrq - axxtxkhuli)
Phase 1/2
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma
Second line | Last line | Third line
EGFR T790M
78
kaaiftiagf(qyuatitvtx) = cmpeebmfho thzxhunzdt (oskhrcsqfj )
Positive
08 Oct 2024
Phase 3
Non-Small Cell Lung Cancer
First line
EGFR Exon 19 Deletion | EGFR L858R
858
RYBREVANT in combination with lazertinib
qahydgbmuk(nptvutvhdp) = abxemzfmmb ptlsfxsmug (mpmatzalfr, 19.1 - 27.7)
Positive
19 Sep 2024
qahydgbmuk(nptvutvhdp) = xcglqewdzs ptlsfxsmug (mpmatzalfr, 14.8 - 18.5)
Phase 2
Non-Small Cell Lung Cancer
First line
uncommon EGFR mutation
36
vyitlcshjd(oecajjdhok) = vadkdljios wuebxbmzaz (mzzoulinxu )
Positive
14 Sep 2024
Lazertinib 240mg
(G719X)
vyitlcshjd(oecajjdhok) = niplrbjunx wuebxbmzaz (mzzoulinxu )
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