| Primary | Part D: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs were defined as AEs that started on or after the first dose of study medication and prior to 28-day follow-up period. All TEAEs including serious and non-serious events are reported in this outcome measure. | The safety analysis population included all participants who received at least 1 dose of investigational product (IP). | Posted | | Count of Participants | | Participants | | From Day 1 up to 14 months | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Primary | Part D: Number of Participants With Clinically Significant Abnormalities in Vital Signs | Number of participants with clinically significant abnormalities in vital signs were reported. Vital signs included pulse rate, systolic blood pressure, diastolic blood pressure, body temperature, height, weight, and body mass index (BMI). Baseline was defined as last non-missing measurement taken prior to reference start date. | The safety analysis population included all participants who received at least 1 dose of IP. | Posted | | Count of Participants | | Participants | | From Day 1 up to 14 months | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Primary | Part D: Number of Participants With Clinically Significant Abnormalities in Physical Examination | Number of participants with clinically significant abnormalities in physical examination were reported. Physical examination included general appearance, skin, head and neck (including ears, eyes, nose and throat), respiratory, cardiovascular, abdomen, lymph nodes, thyroid, muscular-skeletal (including spine and extremities) and neurological systems. Baseline was defined as last non-missing measurement taken prior to reference start date. | The safety analysis population included all participants who received at least 1 dose of IP. | Posted | | Count of Participants | | Participants | | From Day 1 up to 14 months | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Primary | Part D: Number of Participants With Greater Than or Equal to (>=) Grade 4 Toxicity in Laboratory Tests Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03 | Safety laboratory assessments included clinical chemistry, hematology and urinalysis. Grading was done as per NCI CTCAE version 4.03: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death. Baseline was defined as last non-missing measurement taken prior to reference start date. | The safety analysis population included all participants who received at least 1 dose of IP. | Posted | | Count of Participants | | Participants | | From Day 1 up to 14 months | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Primary | Part D: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Tests | Number of participants with clinically significant abnormalities in electrocardiogram (ECG) tests were reported. ECG variables included heart rate, PR interval, RR interval, QRS interval, QT interval and Fridericia-corrected QT interval (QTcF). Baseline was defined as last non-missing measurement taken prior to reference start date. | The safety analysis population included all participants who received at least 1 dose of IP. | Posted | | Count of Participants | | Participants | | From Day 1 up to 14 months | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Primary | Part D: Area Under the Plasma Concentration Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-last]) for Single Dose of Lazertinib | AUC(0-last) was defined as area under the plasma concentration-time curve from time zero to time of last quantifiable concentration. AUC(0-last) for single dose of lazertinib was reported in this outcome measure. The concentrations of lazertinib were measured using a validated, specific, and sensitive liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) method. | Pharmacokinetic (PK) analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Hour*nanograms per milliliter (h*ng/mL) | | Pre-dose, 1, 2, 4, 10, 24 and 48 hours post-dose on Day 1 of Cycle 0 | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Primary | Part D: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC[0-Infinity]) for Single Dose of Lazertinib | AUC(0-infinity) was defined as area under the plasma concentration time curve from time zero to infinite time. AUC(0-infinity) for single dose of lazertinib was reported in this outcome measure. The concentrations of lazertinib were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose, 1, 2, 4, 10, 24 and 48 hours post-dose on Day 1 of Cycle 0 | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Primary | Part D: Area Under the Plasma Concentration Time Curve From Time Zero to 24 Hours (AUC[0-24]) for Single Dose of Lazertinib | AUC(0-24) was defined as area under the plasma concentration time curve from time zero to 24 hours. AUC(0-24) for single dose of lazertinib was reported in this outcome measure. The concentrations of lazertinib were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose, 1, 2, 4, 10 and 24 hours post-dose on Day 1 of Cycle 0 | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Primary | Part D: Maximum Observed Plasma Concentration (Cmax) for Single Dose of Lazertinib | Cmax was defined as maximum observed plasma concentration. Cmax for single dose of lazertinib was reported in this outcome measure. The concentrations of lazertinib were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Nanograms per milliliter (ng/mL) | | Pre-dose, 1, 2, 4, 10, 24 and 48 hours post-dose on Day 1 of Cycle 0 | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Primary | Part D: Time to Reach Maximum Observed Plasma Concentration (Tmax) for Single Dose of Lazertinib | Tmax was defined as time to reach the maximum observed plasma concentration. Tmax for single dose of lazertinib was reported in this outcome measure. The concentrations of lazertinib were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Median | Full Range | Hours | | Pre-dose, 1, 2, 4, 10, 24 and 48 hours post-dose on Day 1 of Cycle 0 | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Primary | Part D: Apparent Terminal Half-Life (t1/2) for Single Dose of Lazertinib | T1/2 was defined the time measured for the plasma concentration of a drug to decrease by half of its initial concentration. T1/2 for single dose of lazertinib was reported in this outcome measure. The concentrations of lazertinib were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Median | Full Range | Hours | | Pre-dose, 1, 2, 4, 10, 24 and 48 hours post-dose on Day 1 of Cycle 0 | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Primary | Part D: Apparent Terminal Elimination Rate Constant (Lambda[z]) for Single Dose of Lazertinib | Lambda(z) was defined as terminal elimination rate constant. Lambda(z) for single dose of lazertinib was reported in this outcome measure. The concentrations of lazertinib were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Per hour (1/h) | | Pre-dose, 1, 2, 4, 10, 24 and 48 hours post-dose on Day 1 of Cycle 0 | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Primary | Part D: Apparent Plasma Clearance (CL/F) for Single Dose of Lazertinib | CL/F was defined as apparent plasma clearance. CL/F for single dose of lazertinib was reported in this outcome measure. The concentrations of lazertinib were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Liters per hour (L/h) | | Pre-dose, 1, 2, 4, 10, 24 and 48 hours post-dose on Day 1 of Cycle 0 | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Primary | Part D: Apparent Volume of Distribution (Vd/F) for Single Dose of Lazertinib | Vd/F was defined as apparent volume of distribution. Vd/F for single dose of lazertinib was reported in this outcome measure. The concentrations of lazertinib were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Liters | | Pre-dose, 1, 2, 4, 10, 24 and 48 hours post-dose on Day 1 of Cycle 0 | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Primary | Part D: Area Under the Plasma Concentration Time Curve From Time Zero to the Time of the End of Dosing Interval at Steady State (AUCss[0-last]) for Multiple Dose of Lazertinib | AUCss(0-last) was defined as area under the plasma concentration time curve from time zero to end of dosing interval at steady state. AUCss(0-last) for multiple dose of lazertinib was reported in this outcome measure. The concentrations of lazertinib were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose up to 1, 2, 4, 10 and 24 hours post dose on Day 1 of Cycle 2 | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Primary | Part D: Maximum Observed Plasma Concentration at Steady State (Cmax,ss) for Multiple Dose of Lazertinib | Cmax,ss was defined as maximum observed plasma concentration at steady state. Cmax,ss for multiple dose of lazertinib was reported in this outcome measure. The concentrations of lazertinib were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose up to 1, 2, 4, 10 and 24 hours post dose on Day 1 of Cycle 2 | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Primary | Part D: Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss) for Multiple Dose of Lazertinib | Tmax,ss was defined as time to reach maximum observed plasma concentration at steady state. Tmax,ss for multiple dose of lazertinib was reported in this outcome measure. The concentrations of lazertinib were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Median | Full Range | Hours | | Pre-dose up to 1, 2, 4, 10 and 24 hours post dose on Day 1 of Cycle 2 | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Primary | Part D: Accumulation Ratio (Rac) for Multiple Dose of Lazertinib | Accumulation ratio was calculated as AUCss(0-last) divided by AUC(0-24), where AUCss(0-last) was defined as area under the plasma concentration time curve from time zero to end of dosing interval at steady state and AUC(0-24) was defined area under the plasma concentration time curve from time zero to 24 hours time. Rac for multiple dose of lazertinib was reported in this outcome measure. The concentrations of lazertinib were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Ratio | | Pre-dose up to 1, 2, 4, 10 and 24 hours post dose on Day 1 of Cycle 2 | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Primary | Part D: Apparent Plasma Clearance at Steady State (CLss/F) for Multiple Dose of Lazertinib | CLss/F was defined as apparent plasma clearance at steady state. CLss/F for multiple dose of lazertinib was reported in this outcome measure. The concentrations of lazertinib were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Liters per hour (L/h) | | Pre-dose up to 1, 2, 4, 10 and 24 hours post dose on Day 1 of Cycle 2 | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Primary | Part D: Trough Concentrations (Ctrough) for Multiple Dose of Lazertinib at Cycle 1 Day 1 | Ctrough was defined as pre-dose plasma concentration. Ctrough for multiple dose of lazertinib at Cycle 1 Day 1 was reported in this outcome measure. The concentrations of lazertinib were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 1 of Cycle 1 | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Primary | Part D: Trough Concentrations (Ctrough) for Multiple Dose of Lazertinib at Cycle 1 Day 8 | Ctrough was defined as pre-dose plasma concentration. Ctrough for multiple dose of lazertinib at Cycle 1 Day 8 was reported in this outcome measure. The concentrations of lazertinib were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 8 of Cycle 1 | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Primary | Part D: Trough Concentrations (Ctrough) for Multiple Dose of Lazertinib at Cycle 1 Day 15 | Ctrough was defined as pre-dose plasma concentration. Ctrough for multiple dose of lazertinib at Cycle 1 Day 15 was reported in this outcome measure. The concentrations of lazertinib were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 15 of Cycle 1 | | | | ID | Title | Description |
|---|
| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Secondary | Part D: Area Under the Plasma Concentration Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-last]) of Metabolite M7 After Single Dose of Lazertinib | AUC(0-last) was defined as area under the plasma concentration-time curve from time zero to time of last quantifiable concentration. AUC(0-last) of metabolite M7 after single dose of lazertinib was reported in this outcome measure. The concentrations of metabolite M7 were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose, 1, 2, 4, 10, 24 and 48 hours post-dose on Day 1 of Cycle 0 | | | | ID | Title | Description |
|---|
| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Secondary | Part D: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUC[0-Infinity]) of Metabolite M7 After Single Dose of Lazertinib | AUC(0-infinity) was defined as area under the plasma concentration time curve from time zero to infinite time. AUC(0-infinity) of metabolite M7 after single dose of lazertinib was reported in this outcome measure. The concentrations of metabolite M7 were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose, 1, 2, 4, 10, 24 and 48 hours post-dose on Day 1 of Cycle 0 | | | | ID | Title | Description |
|---|
| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Secondary | Part D: Area Under the Plasma Concentration Time Curve From Time Zero to 24 Hours (AUC[0-24]) of Metabolite M7 After Single Dose of Lazertinib | AUC(0-24) was defined as area under the plasma concentration time curve from time zero to 24 hours. AUC(0-24) of metabolite M7 after single dose of lazertinib was reported in this outcome measure. The concentrations of metabolite M7 were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose, 1, 2, 4, 10 and 24 hours post-dose on Day 1 of Cycle 0 | | | | ID | Title | Description |
|---|
| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Secondary | Part D: Maximum Observed Plasma Concentration (Cmax) of Metabolite M7 After Single Dose of Lazertinib | Cmax was defined as maximum observed plasma concentration. Cmax of metabolite M7 after single dose of lazertinib was reported in this outcome measure. The concentrations of metabolite M7 were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose, 1, 2, 4, 10, 24 and 48 hours post-dose on Day 1 of Cycle 0 | | | | ID | Title | Description |
|---|
| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Secondary | Part D: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Metabolite M7 After Single Dose of Lazertinib | Tmax was defined as time to reach the maximum observed plasma concentration. Tmax of metabolite M7 after single dose of lazertinib was reported in this outcome measure. The concentrations of metabolite M7 were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Median | Full Range | Hours | | Pre-dose, 1, 2, 4, 10, 24 and 48 hours post-dose on Day 1 of Cycle 0 | | | | ID | Title | Description |
|---|
| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Secondary | Part D: Apparent Terminal Half-Life (t1/2) of Metabolite M7 After Single Dose of Lazertinib | T1/2 was defined the time measured for the plasma concentration of a drug to decrease by half of its initial concentration. T1/2 of metabolite M7 after single dose of lazertinib was reported in this outcome measure. The concentrations of metabolite M7 were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Median | Full Range | Hours | | Pre-dose, 1, 2, 4, 10, 24 and 48 hours post-dose on Day 1 of Cycle 0 | | | | ID | Title | Description |
|---|
| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Secondary | Part D: Apparent Terminal Elimination Rate Constant (Lambda [z]) of Metabolite M7 After Single Dose of Lazertinib | Lambda(z) was defined as terminal elimination rate constant. Lambda(z) of metabolite M7 after single dose of lazertinib was reported in this outcome measure. The concentrations of metabolite M7 were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Per hour (1/h) | | Pre-dose, 1, 2, 4, 10, 24 and 48 hours post-dose on Day 1 of Cycle 0 | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Secondary | Part D: Metabolic Ratio (MR) of Metabolite M7 and Lazertinib After Single Dose of Lazertinib | MR was defined as ratio of the AUC(0-infinity) of metabolite M7 and AUC(0-infinity) of lazertinib, where AUC(0-infinity) was defined as area under the plasma concentration time curve from time zero to infinite time. The concentrations of metabolite M7 and lazertinib were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Ratio | | Pre-dose, 1, 2, 4, 10, 24 and 48 hours post-dose on Day 1 of Cycle 0 | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Secondary | Part D: Area Under the Plasma Concentration Time Curve From Time Zero to the Time of the End of Dosing Interval at Steady State (AUCss[0-last]) of Metabolite M7 After Multiple Dose of Lazertinib | AUCss(0-last) was defined as area under the plasma concentration-time curve from time zero to time of the end of dosing interval at steady state. AUCss(0-last) of metabolite M7 after multiple dose of lazertinib was reported in this outcome measure. The concentrations of metabolite M7 were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose up to 1, 2, 4, 10 and 24 hours post dose on Day 1 of Cycle 2 | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Secondary | Part D: Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of Metabolite M7 After Multiple Dose of Lazertinib | Cmax,ss was defined as maximum observed plasma concentration at steady state. Cmax,ss of metabolite M7 after multiple dose of lazertinib was reported in this outcome measure. The concentrations of metabolite M7 were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose up to 1, 2, 4, 10 and 24 hours post dose on Day 1 of Cycle 2 | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Secondary | Part D: Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss) of Metabolite M7 After Multiple Dose of Lazertinib | Tmax,ss was defined as time to reach the maximum observed plasma concentration at steady state. Tmax,ss of metabolite M7 after multiple dose of lazertinib was reported in this outcome measure. The concentrations of metabolite M7 were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Median | Full Range | Hours | | Pre-dose up to 1, 2, 4, 10 and 24 hours post dose on Day 1 of Cycle 2 | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Secondary | Part D: Accumulation Ratio (Rac) of Metabolite M7 After Multiple Dose of Lazertinib | Accumulation ratio was calculated as AUCss(0-last) divided by AUC(0-24), where AUCss(0-last) was defined as area under the plasma concentration time curve from time zero to end of dosing interval at steady state and AUC(0-24) was defined area under the plasma concentration time curve from time zero to 24 hours. Rac of metabolite M7 after multiple dose of lazertinib was reported in this outcome measure. The concentrations of metabolite M7 were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Ratio | | Pre-dose up to 1, 2, 4, 10 and 24 hours post dose on Day 1 of Cycle 2 | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Secondary | Part D: Trough Concentrations (Ctrough) of Metabolite M7 After Multiple Dose of Lazertinib at Days 1, 8 and 15 of Cycle 1 | Ctrough was defined as pre-dose plasma concentration. Ctrough of Metabolite M7 after multiple dose of lazertinib at Days 1, 8 and 15 of Cycle 1 was reported in this outcome measure. The concentrations of metabolite M7 were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. Here 'n' (number analyzed) refers to all participants evaluable at specified time points. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Days 1, 8 and 15 of Cycle 1 | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Secondary | Part D: Metabolic Ratio at Steady State (MRss) of Metabolite M7 and Lazertinib After Multiple Dose of Lazertinib | MRss was defined as ratio of the AUCss(0-last) of metabolite M7 and AUCss(0-last) of lazertinib, where AUCss(0-last) was defined as area under the plasma concentration time curve from time zero to time of end of dosing interval at steady state. The concentrations of metabolite M7 and lazertinib were measured using a validated, specific, and sensitive LC-MS/MS method. | PK analysis population included all participants who had at least 1 measurable concentration collected post dose. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Ratio | | Pre-dose up to 1, 2, 4, 10 and 24 hours post dose on Day 1 of Cycle 2 | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Secondary | Objective Response Rate (ORR) | ORR was defined as percentage of participants who had at least 1 confirmed partial or complete response (PR or CR) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 prior to disease progression or recurrence. CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<) 10 millimeter (mm). PR was defined as greater than or equal to (>=) 30 percent (%) decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-progressive disease (PD). PD was defined as >=20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative 20% increase, sum must also demonstrate an absolute increase of >=5 mm. Appearance of one or more new lesions was considered progression. | Evaluable for response population included all participants in safety analysis population who had a baseline RECIST version 1.1 assessment. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Up to 33.7 months | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Secondary | Duration of Response (DoR) | DOR was defined as time between date of first documented confirmed response (PR/CR) and date of first documented progression or death, whichever occurred first. CR was defined as disappearance of target and non-target lesions and normalization of tumour markers. Pathological lymph nodes short axis measures <10 mm. PR was defined as >=30% decrease in sum of measures (tumour lesions-longest diameter and nodes-short axis)of target lesions, taking as reference baseline sum of diameters. PD was defined as >=20% increase in sum of diameters of measured lesions taking as references smallest sum of diameters recorded on study(including baseline), absolute increase of >=5 mm/appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. | Evaluable for response population included all participants in safety analysis population who had a baseline RECIST version 1.1 assessment. Here 'N' (number of participants analyzed) refers to number of participants evaluable for this outcome measure. | Posted | | Median | 95% Confidence Interval | Months | | Up to 33.7 months | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 |
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| Secondary | Disease Control Rate (DCR) | DCR was defined as percentage of participants with a best overall response (BOR), extracranial and intracranial response of CR, PR or stable disease (SD). As per RECIST version 1.1 CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR was defined as >=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD was defined as >=20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative 20% increase, sum must also demonstrate >=5 mm absolute increase. Appearance of one or more new lesions was considered progression. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. | Evaluable for response population included all participants in safety analysis population who had a baseline RECIST version 1.1 assessment. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Up to 33.7 months | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Secondary | Percentage Change From Baseline in Tumor Size | Tumor size was defined as the sum lengths of the longest diameters of the target lesion. Percentage change in tumor size was determined for participants with measurable disease at baseline. Baseline for RECIST version 1.1 was defined as the last evaluable assessment prior to starting treatment. | Evaluable for response population included all participants in safety analysis population who had a baseline RECIST version 1.1 assessment. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Percentage change in tumor size | | Baseline up to 33.7 months | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Secondary | Progression Free Survival (PFS) | PFS was defined as the time from the date of first dose of study drug to the earliest date of disease progression per RECIST version 1.1, or death due to any cause, whichever occurs first. PD was defined as at least 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of >=5 mm or appearance of at least 1 new lesion. | The safety analysis population included all participants who received at least 1 dose of IP. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Median | Full Range | Months | | Up to 33.7 months | | | | ID | Title | Description |
|---|
| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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| Secondary | Overall Survival (OS) | OS was defined as the time from the date of first dose to date of death due to any cause. | The safety analysis population included all participants who received at least 1 dose of IP. Here 'N' (number of participants analyzed) refers to the number of participants evaluable for this outcome measure. | Posted | | Median | Full Range | Months | | Up to 33.7 months | | | | ID | Title | Description |
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| OG000 | Lazertinib 240 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 240 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 32.7 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. | | OG001 | Lazertinib 320 mg | Participants with EGFRm+ advanced NSCLC with or without asymptomatic brain metastasis received lazertinib tablet at a dose of 320 mg orally on Day 1 of Cycle 0, which spans 7 days, followed by a once daily dose in each subsequent 21-day treatment cycle, for a maximum duration of up to 8.3 months. Participants were then followed up for safety for 28 days after the last dose of study treatment. |
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