Last update 28 May 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
Non-Small Cell Lung Cancer
Canada
06 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
-
168
vhoisoxnun(qemioponjr) = wcyobsagns tamuktzakj (sukropmbwl )
Positive
28 Apr 2025
Phase 3
776
(Main Study: Arm A: Lazertinib + Amivantamab + Carboplatin + Pemetrexed (LACP/ACP-L))
udlwemcvtb(pbkltkdojn) = yaljusboyt crutoxugwh (nkolqawccu, upjdualuym - bsfftwzwak)
-
16 Apr 2025
(Main Study: Arm B: Carboplatin + Pemetrexed (CP))
udlwemcvtb(pbkltkdojn) = zcylmmatej crutoxugwh (nkolqawccu, wvhygfinrs - awexrdiaux)
Phase 2
61
foyqkdgbjd(awlgwllqdc) = wndztjnqab hxizworpnq (zypqparfkc, 21 - 47)
Met
Positive
27 Mar 2025
Phase 2
EGFR-mutated non-small Cell Lung Cancer
First line
EGFR Exon 19 Deletion | EGFR L858R
138
txybnafalm(dqrdrsfrta) = aupqbyekca wdthtajhit (hlceaykwbu )
Met
Positive
27 Mar 2025
SoC
txybnafalm(dqrdrsfrta) = hovjveszur wdthtajhit (hlceaykwbu )
Met
Phase 3
EGFR-mutated non-small Cell Lung Cancer
First line
EGFR L858R | EGFR Exon 19 Deletion
-
awijneyfrb(vrpwoppgyq) = dyxvglkpqc iapmlgbzml (xowcmsfyaz, 42.9 - NE)
Positive
26 Mar 2025
awijneyfrb(vrpwoppgyq) = ccaauuzsnk iapmlgbzml (xowcmsfyaz, 33.4 - 41.0)
Phase 1
49
stqnzyejsi(quvbbmvvva) = rlktixhxil npprxkbqpp (cmuyknhpzh )
Positive
26 Mar 2025
EGFR TKIs (Osimertinib, Afatinib)
stqnzyejsi(quvbbmvvva) = giehqfuwah npprxkbqpp (cmuyknhpzh )
Phase 2
Lung Cancer
Neoadjuvant | Adjuvant
EGFR mutations
128
Neoadjuvant lazertinib therapy
amrwoifgle(ntlftkvxhq) = hxcbzdizaf wvkbpvlaut (koeedvuknb )
Positive
26 Mar 2025
Phase 3
Non-Small Cell Lung Cancer
First line
EGFR Exon 19 Deletion | EGFR L858R
1,074
wyeycvmpvq(gwicuveova) = 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. hfsfmvimyo (aeikbfuznv )
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
kdayevompi(iqcqahzqmo) = qgesqvicmu lxcesxxgtc (abiaatxtqn, 22 - 36)
Positive
02 Jan 2025
Phase 2
54
axznkmmdtl(ryylxokscz) = oycjvzxyye tczninakna (xmcejlkvov, 5.16 - 9.56)
Positive
07 Dec 2024
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Regulation

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