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LAZCLUZE®

(lazertinib)

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LAZCLUZE® (lazertinib)

Medical Information

Comparison of LAZCLUZE to Osimertinib

Last Updated: 11/24/2025

SUMMARY

  • LAZCLUZE (lazertinib) is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI).1
  • No prospective, randomized, head-to-head trials comparing the efficacy and safety of LAZCLUZE with osimertinib have been published.
  • MARIPOSA (NCT04487080) is an ongoing, phase 3, randomized study evaluating the efficacy and safety of RYBREVANT (amivantamab-vmjw) and LAZCLUZE combination therapy (open-label, n=429) vs osimertinib (double-blind, n=429) vs LAZCLUZE (double-blind, n=216) as first-line treatment in patients with EGFR-mutated (Exon 19 deletion [Exon19del] or Exon 21 L858R substitution) locally advanced or metastatic non-small cell lung cancer (NSCLC). The primary endpoint (RYBREVANT plus LAZCLUZE vs osimertinib) is progression-free survival (PFS), based on blinded independent central review (BICR).1-3
    • The study was not designed to evaluate a statistical analysis between the LAZCLUZE and osimertinib arms.
    • LAZCLUZE monotherapy was administered to patients to evaluate the contribution of the components in the combination treatment.3
  • A randomized, double-blind, exploratory analysis evaluated the efficacy and safety of single-agent LAZCLUZE (n=216) vs osimertinib (n=429) in patients with EGFR-mutated locally advanced or metastatic NSCLC enrolled in the MARIPOSA study.4
    • At a median follow-up of 22 months, median PFS by BICR for LAZCLUZE vs osimertinib was 18.5 months (95% confidence interval [CI], 14.8-20.1) vs 16.6 months (95% CI, 14.8-18.5; hazard ratio [HR], 0.98 [95% CI, 0.79-1.22]; P=0.86).
    • Most treatment-emergent adverse events (TEAEs) were grade 1-2 in severity for LAZCLUZE and osimertinib. The most common TEAEs for LAZCLUZE vs osimertinib were diarrhea (32% vs 44%), rash (45% vs 31%), paronychia (29% vs 28%), coronavirus disease 2019 (COVID-19, 20% vs 24%), and anemia (20% vs 21%).
    • Lower rates of cardiomyopathy (1% vs 4%) and QT interval prolongation (>450 msec, 9% vs 17%) were observed with LAZCLUZE vs osimertinib.
  • A real-world study evaluating the effectiveness of LAZCLUZE vs osimertinib in patients with advanced EGFR T790M-positive NSCLC has been published.5

PRODUCT LABELING

clinical study

MARIPOSA Study

Study Design/Methods

  • Ongoing phase 3, randomized study designed to evaluate the efficacy and safety of RYBREVANT and LAZCLUZE combination therapy (open-label) vs osimertinib (double-blind) vs LAZCLUZE (double-blind) as first-line treatment in patients with EGFR-mutated (Exon19del or Exon 21 L858R substitution) locally advanced or metastatic NSCLC.1-4 
  • The study design is shown in Figure: MARIPOSA Study Design.
    • The study was not designed to evaluate a statistical analysis between the LAZCLUZE and osimertinib arms.1-3 

MARIPOSA Study Design1-4

MARIPOSA (ClinicalTrials.gov Identifier: NCT04487080) enrollment period: November 2020 to May 2022; data cutoff: August 11, 2023.
Abbreviations: BICR, blinded independent central review; C, cycle; D, day; CT, computed tomography; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; EORTC-QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; Exon19del, Exon 19 deletion; icPFS, intracranial PFS; IV, intravenous; MRI, magnetic resonance imaging; NSCLC, non-small cell lung cancer; NSCLC-SAQ, NSCLC-Symptom Assessment Questionnaire; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PFS2, PFS after first subsequent therapy; PO, orally; PRO, patient-reported outcome; QD, once daily; Q2W, every 2 weeks; Q8W, every 8 weeks; Q12W, every 12 weeks; Q24W, every 24 weeks; QW, once a week; R, randomization; RECIST v1.1, Response Evaluation Criteria in Solid Tumors version 1.1; TTD, time to treatment discontinuation; TTSP, time to symptomatic progression; TTST, time to subsequent therapy.
aIn patients <80 kg.
bIn patients ≥80 kg.
cThe first infusion was split over 2 days (350 mg on C1D1, and the remainder on C1D2).
dPatients with asymptomatic or previously treated and stable brain metastases were eligible. Serial brain MRIs were required for all patients. Baseline brain MRI was required for all patients and performed ≤28 days prior to randomization; patients who could not have MRIs were allowed to have CT scans. Brain scan frequency was Q8W for the first 30 months and then Q12W thereafter for patients with a history of brain metastasis and Q24W for patients with no history of brain metastasis. Extracranial tumor assessments were conducted Q8W for the first 30 months and then Q12W until disease progression was confirmed by BICR.
eStatistical hypothesis testing included PFS and then OS.
fAssessed using EORTC-QLQ-C30 and NSCLC-SAQ.
gThis secondary endpoint will be presented at a future congress.
hAlso included death.

MARIPOSA Study: Exploratory Analysis

Study Design/Methods

  • A randomized, double-blind, exploratory analysis evaluated the efficacy and safety of single-agent LAZCLUZE (n=216) vs osimertinib (n=429) in patients with EGFR-mutated locally advanced or metastatic NSCLC enrolled in the MARIPOSA study.4

Results

Patient Characteristics
  • The patient demographics and baseline characteristics are included in Table: Demographics and Baseline Disease Characteristics.
  • At a median follow-up of 22 months, the median duration of treatment for LAZCLUZE vs osimertinib was 17.1 months (range, 0.4-32.1) vs 18 months (range, 0.2-32.7).4
  • Overall, 106 (50%) patients in the LAZCLUZE arm and 213 (50%) patients in the osimertinib arm were still receiving the assigned treatment.4
  • The most common reasons for treatment discontinuation for LAZCLUZE vs osimertinib were progressive disease (72 [34%] vs 154 [36%]) and adverse events (AEs, 29 [14%] vs 50 [12%]).4

Demographics and Baseline Disease Characteristics4
Characteristic
LAZCLUZE (n=216)
Osimertinib (n=429)
Median age, years (range)
63 (31-87)
63 (28-88)
   <65 years, n (%)
119 (55)
237 (55)
   65 to <75 years, n (%)
79 (37)
139 (32)
   ≥75, years, n (%)
18 (8)
53 (12)
Female, n (%)
136 (63)
251 (59)
Race,a n (%)
   Asian
128 (59)
251 (59)
   White
79 (37)
165 (38)
   American Indian or Alaska Native
4 (2)
7 (2)
   Black or African American
4 (2)
3 (1)
   Native Hawaiian or Pacific Islander
0
1 (0.2)
   Multiple
0
1 (0.2)
   Unknown
1 (0.5)
1 (0.2)
Median body weight, kg (range)
60.5 (41-118)
62.4 (35-109)
   <80 kg, n (%)
197 (91)
368 (86)
   ≥80 kg, n (%)
19 (9)
61 (14)
ECOG PS,b n (%)
   0
76 (35)
149 (35)
   1
140 (65)
280 (65)
History of tobacco use, n (%)
73 (34)
134 (31)
Median time from initial diagnosis to
randomization, month (range)
1.3 (0.2-197.3)
1.4 (0.3-162.8)
Median time from metastatic disease diagnosis to randomization, month (range)
1.2 (0.2-9.2)
1.2 (0.1-11.7)
Histologic type, n (%)
   Adenocarcinoma
212 (98)
415 (97)
   Large cell carcinoma
0
0
   Squamous cell carcinoma
2 (1)
5 (1)
   Otherc
2 (1)
9 (2)
   Not reported
0
0
History of brain metastasis, n (%)
86 (40)
172 (40)
EGFR mutation, n (%)
   Exon19del
131 (61)
257 (60)
   Exon 21 L858R
85 (39)
172 (40)
Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; Exon19del, Exon 19 deletion.
aRace or ethnic group was reported by the patients.
bECOG PS scores range from 0 to 5, with higher scores indicating greater disability.
cOther histologic types included: adenocarcinoma and squamous cell carcinoma, lepidic adenocarcinoma, non-small cell carcinoma, pleomorphic carcinoma, and unknown.
Note: Percentages may not sum to 100 due to rounding.
Efficacy
  • Median PFS by BICR for LAZCLUZE vs osimertinib was 18.5 months (95% CI, 14.8-20.1) vs 16.6 months (95% CI, 14.8-18.5; HR, 0.98 [95% CI, 0.79-1.22]; P=0.86).4
    • The PFS rates for LAZCLUZE vs osimertinib were 67% (95% CI, 60-73) vs 65% (95% CI, 60-69) at 12 months, 52% (95% CI, 44-58) vs 48% (95% CI, 43-53) at 18 months, and 35% (95% CI, 27-42) vs 34% (95% CI, 28-39) at 24 months.
    • PFS across prespecified and high-risk subgroups was evaluated for LAZCLUZE vs osimertinib (Table: PFS Across Prespecified Subgroups and Table: PFS Across High-risk Subgroups, respectively).

PFS Across Prespecified Subgroups4,a
Prespecified Subgroup
Events/N
HR (95% CI)
LAZCLUZE
Osimertinib
All randomized patients
121/216
252/429
0.98 (0.79-1.22)
Age
   <65 years
67/119
153/237
0.83 (0.62-1.11)
   ≥65 years
54/97
99/192
1.20 (0.86-1.67)
   <75 years
113/198
220/376
0.99 (0.79-1.25)
   ≥75 years
8/18
32/53
0.83 (0.38-1.80)
Sex
   Female
68/136
140/251
0.88 (0.66-1.18)
   Male
53/80
112/178
1.18 (0.85-1.63)
Race
   Asian
72/128
144/251
1.02 (0.77–1.35)
   Non-Asian
49/87
108/177
0.93 (0.66–1.30)
Body weight
   <80 kg
107/197
209/368
0.99 (0.78–1.25)
   ≥80 kg
14/19
43/61
1.01 (0.55–1.85)
ECOG PS 0
42/76
76/149
1.19 (0.81–1.73)
ECOG PS 1
79/140
176/280
0.88 (0.68–1.15)
EGFR mutation
   Exon19del
73/131
142/257
1.03 (0.78-1.37)
   Exon 21 L858R
48/85
110/172
0.91 (0.65-1.28)
History of smoking
   Yes
42/73
79/134
0.95 (0.66–1.39)
   No
79/143
173/295
0.98 (0.75–1.27)
Abbreviations: BICR, blinded independent central review; CI, confidence interval; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; Exon19del, Exon 19 deletion; HR, hazard ratio; PFS, progression-free survival.
aPFS was assessed by BICR.

PFS Across High-risk Subgroups4,6
High-risk Subgroup
Number of Patients at Risk; Median PFS (95% CI), Months
HR (95% CI);
P-Value
LAZCLUZE
Osimertinib
History of brain metastases
   Yes
n=86;
16.4 (12.9-19.4)
n=172;
13 (12.2-16.4)
0.90 (0.65-1.25); P=0.54
   No
n=130
n=257
1.01 (0.75-1.35)
Detectable ctDNA at baseline
   Presenta
n=115;
18.4 (14.7-20.2)
n=274;
14.8 (12.9-16.6)
0.88 (0.66-1.17);
P=0.38
   Absent
n=31
n=42
1.32 (0.99-1.75)
TP53 mutation status at baseline
TP53 co-mutationsa
n=62;
14.6 (11-19.4)
n=144;
12.9 (11.1-14.7)
0.85 (0.58-1.23);
P=0.38
TP53 wild type
n=84
n=172
0.95 (0.71-1.26)
Abbreviations: CI, confidence interval; ctDNA, circulating tumor DNA; HR, hazard ratio; PFS, progression-free survival; TP53, tumor protein p53.
aPathogenic alterations were detected with the Guardant Health G360® panel.
  • The objective response rate (ORR), best response, and duration of response (DOR) by BICR for LAZCLUZE vs osimertinib are included in Table: ORR, Best Response, and DOR by BICR.

ORR, Best Response, and DOR by BICR4
BICR-Assessed Response
LAZCLUZE (n=216)
Osimertinib (n=429)
ORa (95% CI);
P-value
ORR,b % (95% CI)
   All responders
83 (77-88)
85 (81-88)
0.88 (0.56-1.37); 0.57
   Confirmed responders
75 (68-80)
76 (71-80)
-
Best response,c n (%)
   CR
9 (4)
15 (4)
-
   PR
168 (79)
335 (81)
-
   SD
23 (11)
42 (10)
-
   PD
9 (4)
11 (3)
-
   NE
5 (2)
11 (3)
-
Median DOR,b,d months (95% CI)
16.6 (14.8-20.2)
16.8 (14.8-18.5)
-
Ongoing responses, n/n (%)
77/160 (48)
 151/314 (48)
-
Abbreviations: BICR, blinded independent central review; CI, confidence interval; CR, complete response; DOR, duration of response; NE, not estimable; OR, odds ratio; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease.
aThe OR was from a logistic regression model stratified by EGFR mutation type, Asian race, and history of brain metastasis; 95% CI widths have not been adjusted for multiplicity and cannot be used to infer definitive treatment effects.
bNumber of patients with measurable disease at baseline was 214 for LAZCLUZE and 414 for osimertinib.
cConfirmation was not required for CR and PR.
dAmong confirmed responders.
  • Median time to symptomatic progression (TTSP) was not estimable for the LAZCLUZE arm and 29.3 months (95% CI, 25.3-NE) for the osimertinib arm (HR, 0.85; 95% CI, 0.65-1.13; P=0.27).4
  • Post-progression endpoints for LAZCLUZE vs osimertinib are summarized in Table: Post-progression Efficacy Endpoints.
  • Among patients who discontinued the study treatment, 77% in the LAZCLUZE arm and 73% in the osimertinib arm started a subsequent therapy. The most common first subsequent therapy class was chemotherapy alone in both arms.4
  • At the interim analysis, median overall survival (OS) for LAZCLUZE vs osimertinib was NE for both arms (HR, 1 [95% CI, 0.73-1.38]; P=1). Overall, 86% (95% CI, 81-90), 78% (95% CI, 71-83), and 71% (95% CI, 64-78) of patients in the LAZCLUZE arm and 88% (95% CI, 85-91), 79% (95% CI, 75-83), and 69% (95% CI, 64-74) of patients in the osimertinib arm were alive at 12 months, 18 months, and 24 months, respectively.4

Post-progression Efficacy Endpoints6
Endpoint, median months (95% CI)
LAZCLUZE (n=216)
Osimertinib (n=429)
HR (95%CI)
P-value
TTDa
22.5 (18.3-NE)
23 (20.3-25.3)
1.05 (0.83-1.32)
0.699
TTSTb
24 (19.45-NE)
24.1 (22-29)
1.06 (0.83-1.36)
0.617
PFS2c
28.9 (28.9-NE)
NE (29.3-NE)
0.94 (0.69-1.28)
0.701
Abbreviations: CI, confidence interval; HR, hazard ratio; NE, not estimable; PFS2, progression-free survival after first subsequent therapy; TTD, time to treatment discontinuation; TTSP, time to symptomatic progression; TTST, time to subsequent therapy.
aTime from randomization to discontinuation of treatment for any reason.
bTime from randomization to the start of the subsequent therapy following study treatment discontinuation or death.
cTime from randomization until the date of the second objective disease progression after initiation of subsequent anticancer therapy or death.
Safety
  • Most common AEs were grade 1-2 in severity for LAZCLUZE and osimertinib (Table: Safety Summary).4

Safety Summary4,6,a
AEs, n (%)
LAZCLUZE (n=213)
Osimertinib (n=428)
Any AE
213 (100)
425 (99)
Grade ≥3 AEs
97 (46)
183 (43)
Serious AEs
75 (35)
143 (33)
AEs leading to death
12 (6)
31 (7)
Any AE leading to:
   Interruption of any agentb,c
92 (43)
165 (39)
   Reduction of any agentd
27 (13)
23 (5)
   Discontinuation of any agente
28 (13)
58 (14)
Abbreviations: AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; COVID-19, coronavirus disease 2019; IRR, infusion-related reaction; ILD, interstitial lung disease.
aThe safety population included all the patients who had undergone randomization and received ≥1 dose of any study treatment.
bExcluding IRRs.
cThe most common AEs leading to interruption of any agent (≥3% in any group) included COVID-19, pneumonia, increased ALT, increased AST, and rash.
dThe most common AEs leading to dose reduction of any agent (≥1% in any group) included rash, peripheral neuropathy, and peripheral sensory neuropathy.
eThe most common AEs leading to discontinuation of any agent (≥1% in any group) included pneumonitis, ILD, and pneumonia.
  • The incidence of TEAEs is summarized in Table: Summary of TEAEs.
  • The combined incidence of interstitial lung disease and pneumonitis was 3% for both LAZCLUZE and osimertinib.4

Summary of TEAEs4,a
Most Common TEAEs (≥15%) by Preferred Term, n (%)
LAZCLUZE (n=213)
Osimertinib (n=428)
All Grade
Grade ≥3
All Grade
Grade ≥3
Rash
95 (45)
4 (2)
131 (31)
3 (1)
Diarrhea
68 (32)
4 (2)
190 (44)
3 (1)
Paronychia
61 (29)
2 (1)
121 (28)
2 (0.5)
ALT increased
50 (23)
6 (3)
57 (13)
8 (2)
Muscle spasms
50 (23)
1 (0.5)
32 (7)
0
AST increased
45 (21)
3 (1)
58 (14)
5 (1)
Dermatitis acneiform
45 (21)
0
55 (13)
0
COVID-19
42 (20)
3 (1)
103 (24)
9 (2)
Anemia
43 (20)
3 (1)
91 (21)
7 (2)
Stomatitis
38 (18)
1 (0.5)
90 (21)
1 (0.2)
Dry skin
38 (18)
0
60 (14)
1 (0.2)
Nausea
38 (18)
1 (0.5)
58 (14)
1 (0.2)
Headache
39 (18)
1 (0.5)
54 (13)
0
Cough
37 (17)
1 (0.5)
88 (21)
0
Pruritus
36 (17)
0
73 (17)
1 (0.2)
Constipation
37 (17)
1 (0.5)
55 (13)
0
Decreased appetite
31 (15)
1 (0.5)
76 (18)
6 (1)
Asthenia
31 (15)
4 (2)
46 (11)
4 (1)
Paresthesia
33 (15)
1 (0.5)
25 (6)
0
Dyspnea
26 (12)
1 (0.5)
68 (16)
17 (4)
Thrombocytopenia
20 (9)
1 (0.5)
84 (20)
5 (1)
Leukopenia
15 (7)
0
66 (15)
0
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; COVID-19, coronavirus disease 2019; TEAE, treatment-emergent adverse events.
aThe safety population included all the patients who had undergone randomization and received ≥1 dose of any study treatment.

Summary of TRAEs6,a
TRAEs, n (%)
LAZCLUZE (n=213)
Osimertinib (n=428)
Any AE
201 (94)
378 (88)
Grade ≥3 AEs
43 (20)
59 (14)
Any serious AE
23 (11)
24 (6)
AEs leading to death
1 (0.5)
2 (0.5)
Any AE leading to:
   Interruption of any agent
54 (25)
81 (19)
   Reduction of any agent
24 (11)
16 (4)
   Discontinuation of any agent
11 (5)
14 (3)
Abbreviations: AE, adverse event; TRAE, treatment-related AEs.
aThe safety population included all the patients who had undergone randomization and received ≥1 dose of any study treatment.

Most Common TRAEs6,a
Most Common (≥15% in Either Arm) TRAEs, n (%)
LAZCLUZE (n=213)
Osimertinib (n=428)
All Grade
Grade ≥3
All Grade
Grade ≥3
Rash
89 (42)
4 (2)
121 (28)
3 (1)
Diarrhea
60 (28)
4 (2)
149 (35)
2 (0.5)
Paronychia
60 (28)
2 (1)
115 (27)
2 (0.5)
Dermatitis acneiform
44 (21)
0
54 (13)
0
ALT increased
39 (18)
4 (2)
38 (9)
4 (1)
Stomatitis
36 (17)
1 (0.5)
77 (18)
1 (0.2)
Dry skin
35 (16)
0
54 (13)
1 (0.2)
AST increased
35 (16)
2 (1)
34 (8)
1 (0.2)
Muscle spasms
35 (16)
0
17 (4)
0
Pruritus
31 (15)
0
63 (15)
1 (0.2)
Thrombocytopenia
17 (8)
0
75 (18)
3 (1)
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; TRAE, treatment-related adverse events.
aThe safety population included all the patients who had undergone randomization and received ≥1 dose of any study treatment.

Incidence, Severity, and Time to Onset of VTEs4,6,a
VTEs, n (%)
LAZCLUZE (n=213)
Osimertinib (n=428)
Any VTE
30 (14)
39 (9)
   Grade 1
1 (0.5)
0
   Grade 2
17 (8)
24 (6)
   Grade 3
9 (4)
12 (3)
   Grade 4
1 (0.5)
1 (0.2)
   Grade 5
2 (1)
2 (0.5)
Serious VTEs
11 (5)
15 (4)
Days to first onset, median (range)
240 (32-774)
194 (10-675)
Onset within first 4 months, n/N (%)
9/30 (30)
13/39 (33)
Abbreviation: VTE, venous thromboembolism.
aIncluded the following preferred terms: pulmonary embolism, deep vein thrombosis, venous thrombosis limb, thrombosis, venous thrombosis, superficial vein thrombosis, thrombophlebitis, embolism, embolism venous, jugular vein thrombosis, pulmonary infarction, axillary vein thrombosis, portal vein thrombosis, post thrombotic syndrome, sigmoid sinus thrombosis, superior sagittal sinus thrombosis, vena cava thrombosis, pelvic venous thrombosis, and pulmonary thrombosis.

Cardiac Safety Profile of LAZCLUZE vs Osimertinib4
Patients, %
LAZCLUZE
Osimertinib
LVEFa
1
4
QT interval prolongationb
   >450 msec
9
17
   >500 msec
0
0.7
Abbreviations: LLN, lower limit of normal; LVEF, left ventricular ejection fraction.
aPatients with LVEF <LLN and >10% absolute decrease from baseline. LLN of LVEF was 45%.
bPatients with maximum postbaseline values.

Literature Search

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 06 November 2025.

References

Show
1 Cho BC, Felip E, Hayashi H, et al. MARIPOSA: phase 3 study of first-line amivantamab + lazertinib versus osimertinib in EGFR-mutant non-small-cell lung cancer. Future Oncol. 2022;18(6):639-647.  
2 Janssen Research & Development, LLC. 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. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 November 6]. Available from: https://clinicaltrials.gov/study/NCT04487080 NLM Identifier: NCT04487080.  
3 Cho BC, Lu S, Felip E, et al. Amivantamab plus lazertinib in previously untreated EGFR-mutated advanced NSCLC. N Engl J Med. 2024;391(16):1486-1498.  
4 Lee SH, Lu S, Hayashi H, et al. Lazertinib versus osimertinib in previously untreated EGFR-mutant advanced NSCLC: a randomized, double-blind, exploratory analysis from MARIPOSA. J Thorac Oncol. 2025;20(11):1655-1668.  
5 Jeon HL, Kwak M, Kim S, et al. Comparative effectiveness of lazertinib in patients with EGFR T790M-positive non-small-cell lung cancer using a real-world external control. Sci Rep. 2024;14(1):14659.  
6 Lee SH, Lu S, Hayashi H, et al. Supplement to: Lazertinib versus osimertinib in previously untreated EGFR-mutant advanced NSCLC: a randomized, double-blind, exploratory analysis from MARIPOSA. J Thorac Oncol. 2025;20(11):1655-1668.