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This Phase III study will be conducted to evaluate the efficacy and safety of YH25448 as first-line treatment in locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) patients with EGFR mutations
YH25448 is an oral, highly potent, mutant-selective and irreversible EGFR Tyrosine-kinase inhibitors (TKIs) that targets both the T790M mutation and activating EGFR mutations while sparing wild type EGFR.
This is a Phase III, Randomized, Double-blind study evaluating the efficacy and safety of YH25448 (240 mg orally, once daily) versus Gefitinib (250 mg orally, once daily) in patients with locally advanced or metastatic NSCLC that is known to be EGFR sensitizing mutation (EGFRm) positive, treatment-naïve and eligible for first-line treatment with an EGFR-TKI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lazertinib + Gefitinib-matching placebo | Experimental | Lazertinib (240 mg or 160 mg orally, once daily) plus Gefitinib-matching placebo (250 mg orally, once daily) in accordance with the randomization schedule |
|
| Gefitinib + Lazertinib-matching placebo | Active Comparator | Gefitinib (250 mg orally, once daily) plus Lazertinib-matching placebo (240 mg or 160 mg orally, once daily) in accordance with the randomization schedule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lazertinib 240 mg/160 mg | Drug | The initial dose of lazertinib 240 mg (3 tablets of 80 mg lazertinib) once daily can be reduced to 160 mg once daily (2 tablets of 80 mg lazertinib) under specific circumstances |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) According to RECIST v1.1 by Investigator Assessment | PFS was defined as the time from randomization until the date of objective progression or death(by any cause whichever comes first based on investigator assessment using RECIST v1.1 and was used to assess the efficacy of lazertinib compared to the gefitinib). | At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression, assessed up to 29 months per participant. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) According to RECIST v1.1 by Investigator Assessments | ORR was defined as the percentage of participants with measurable disease with at least on visit response of complete response(CR) or Partial response(PR) and it was used to further assess the efficacy of lazertinib compared with gefitinib. | At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression, assessed up to 29 months per participant. |
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Inclusion Criteria:
Exclusion Criteria:
Symptomatic and unstable brain metastases
Leptomeningeal metastases
Symptomatic spinal cord compression
History of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
Any medical conditions requiring chronic continuous oxygen therapy
History of any malignancy other than the disease under study within 3 years before randomization
Any cardiovascular disease as follows:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia | ||
| Eugenideio Therapeutirio - Ongcology Department |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37865896 | Derived | Soo RA, Cho BC, Kim JH, Ahn MJ, Lee KH, Zimina A, Orlov S, Bondarenko I, Lee YG, Lim YN, Lee SS, Lee KH, Pang YK, Fong CH, Kang JH, Lim CS, Danchaivijitr P, Kilickap S, Yang JC, Arslan C, Lee H, Park SN, Cicin I. Central Nervous System Outcomes of Lazertinib Versus Gefitinib in EGFR-Mutated Advanced NSCLC: A LASER301 Subset Analysis. J Thorac Oncol. 2023 Dec;18(12):1756-1766. doi: 10.1016/j.jtho.2023.08.017. Epub 2023 Oct 22. | |
| 37379502 |
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De-identified individual participant data (including data dictionaries) that underline the results reported in study-related publications will be made available during the period beginning 1 year and ending 5 years after all trial primary and secondary endpoints were assessed. Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to hmbyun@yuhan.co.kr.
Other documents(i.e. a summary of the study results, study protocol, statistical analysis plan) will be posted in the publicly accessible database (i.e. clinicaltrials.gov) no later than 1 year after the study's primary completion date.
Beginning 1 year and ending 5 years after all trial primary and secondary endpoints were assessed.
Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to hmbyun@yuhan.co.kr.
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During the 28 day screening period, participants were enrolled based on the presence in their tumour of at least 1 of the 2 most frequent Epidermal growth factor receptor (EGFR) mutations. At the time of enrolment, all participants were required to provide biopsy tissue for central testing of the Exon 19 deletion (Ex19del) and L858R mutations.
A total of 393 participants were randomized to treatment at 96 study sites in 13 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lazertinib 240 mg | Randomized participants received Lazertinib 240 mg orally once daily (QD) |
| FG001 | Gefitnib 250 mg | Randomized participants received Gefitinib 250 mg orally once daily (QD) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 3, 2020 | Feb 15, 2024 |
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Approximately 380 patients will be randomized in a 1:1 ratio to either lazertinib (n=190) or gefitinib (n= 190).
Following objective disease progression according to RECIST v1.1, as per investigator assessment, patients who were randomized to gefitinib arm may have the option to receive open-label lazertinib
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|
| Gefitinib 250 mg | Drug | The initial dose for Gefitinib (250 mg once daily) cannot be reduced to a lower dose |
|
|
| Lazertinib-matching placebo 240 mg/160 mg | Drug | The initial dose of lazertinib-matching placebo 240 mg (3 tablets of 80 mg lazertinib-matching placebo) once daily can be reduced to 160 mg once daily (2 tablets of 80 mg lazertinib-matching placebo) under specific circumstances |
|
|
| Gefitinib-matching placebo 250 mg | Drug | The initial dose for Gefitinib-matching placebo (250 mg once daily) cannot be reduced to a lower dose |
|
|
| Duration of Response (DoR) According to RECIST v1.1 by Investigator Assessments | DoR was defined as the time from the date of first documented response(CR or PR) until the date of documented progression or death, whichever comes first and was used to further assess the efficacy of lazertinib compared with gefitinib. | At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression, assessed up to 29 months per participant. |
| Disease Control Rate (DCR) According to RECIST v1.1 by Investigator Assessments | DCR was defined as the percentage of participants who have a best overall response of CR or PR or SD(SD at >= 6weeks prior to any PD event) and was used to further assess the efficacy of lazertinib compared with gefitinib. | At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression, assessed up to 29 months per participant. |
| Depth of Response According to RECIST v1.1 by Investigator Assessments | The depth of response was defined as the best percent change in the sum of diameters of target lesions in the absense of new lesions or progression of non-target lesions compared to the baseline and was used to further assess the efficacy of lazertinib compared with gefitinib. | At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression. |
| Time to Response According to RECIST v1.1 by Investigator Assessments | Time to Response was defined as the time from the date of randomization until the date of first documented response and was used to further assess the efficacy of lazertinib compared with gefitinib. | At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression. |
| Overall Survival (OS) | OS was defined as the time from the date of randomization until the date of death due to any cause and was used to further assess the efficacy of lazertinib compared with gefitinib. | From the randomization to end of study or date of death from any cause, whichever comes first, assessed every 6 weeks. (Up to 29 months per participant.) |
| Plasma Concentrations of Lazertinib | To characterize the pharmacokinetics (PK) of lazertinib. | Blood samples collected from each participant at pre-dose, 1 to 3 hours, and 4 to 6 hours post-dose on Day 1 Cycle 1, Day 1 Cycle 2, Day 1 Cycle 5, Day 1 Cycle 9, and Day 1 Cycle 13. |
| Cerebrospinal Fluid (CSF) Concentrations of Lazertinib | To characterize the pharmacokinetics (PK) of lazertinib. | A cerebrospinal fluid (CSF) sample once collected from participants with brain metastases, at Cycle 5 Day 1 or afterward. |
| Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 Items (QLQ-C30) | The EORTC QLQ-C30 consists of 30 items and measures cancer participants' functioning (health related quality of life (HRQoL)) and symptoms for all cancer types. Questions can be grouped into 5 multi item functional scales (physical, role, emotional, cognitive, and social); 3 multi item symptom scales (fatigue, pain, nausea/vomiting); a 2 item global HRQoL scale; 5 single items assessing additional symptoms commonly reported by cancer participants (dyspnea, loss of appetite, insomnia, constipation, diarrhea) and 1 item on the financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
| Questionnaires completed at Cycle 1 Day1 , Cycle2 Day 1 and then every 6 weeks relative to the randomization date until 28d safety f/u or progression f/u visit(whichever is later). |
| Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Lung Cancer 13 Items (EORTC QLQ-LC13) | The EORTC QLQ-LC13 includes questions assessing cough, hemoptysis, dyspnea, site specific pain (symptoms), sore mouth, dysphagia, peripheral neuropathy, and alopecia (treatment related side effects), and pain medication. The items on both measures were scaled and scored using the recommended EORTC procedures. Raw scores were transformed to a linear scale ranging from 0 to 100, with a higher score representing a higher level of functioning or higher level of symptoms. Provided at least half of the items in the scale were completed, the scale score was calculated using only those items for which values existed. | Questionnaires completed at Cycle 1 Day1 , Cycle2 Day 1 and then every 6 weeks relative to the randomization date until 28d safety f/u or progression f/u visit(whichever is later). |
| Change From Baseline in Euro-Quality of Life-5 Dimension-5 Level (EQ-5D-5L) | The EQ-5D comprises the following two questionnaires:
| Questionnaires completed at Cycle 1 Day1 , Cycle2 Day 1 and then every 6 weeks relative to the randomization date until 28d safety f/u or progression f/u visit(whichever is later). |
| Athens |
| 11528 |
| Greece |
| Attikon Hospital | Athens | 12462 | Greece |
| Theageneio Anticancer Hospital of Thessaloniki | Thessaloniki | 54007 | Greece |
| Debreceni Egyetem | Debrecen | H-4012 | Hungary |
| Törökbálinti Tüdőgyógyintézet | Törökbálint | 2045 | Hungary |
| Hospital Sultan Ismail | Johor Bahru | Johor | 81100 | Malaysia |
| Hospital Raja Perempuan Zainab Ii | Kota Bharu | Kelantan | 15586 | Malaysia |
| Hospital Tengku Ampuan Afzan | Kuantan | Pahang | 25100 | Malaysia |
| Hospital Pulau Pinang | George Town | Pulau Pinang | 10400 | Malaysia |
| Hospital Umum Sarawak | Kuching | Sarawak | 10450 | Malaysia |
| University Malaya Medical Centre | Kuala Lumpur | Selangor | 59100 | Malaysia |
| Manila Doctors Hospital - Clinical Trial Office | Manila | Quezon | 1000 | Philippines |
| Perpetual Succour Hospital | Cebu | 6000 | Philippines |
| Philippine General Hospital | Manila | 1000 | Philippines |
| Arkhangelsk Regional Clinical Oncological Dispensary | Arkhangelsk | Arkhangelskaya oblast | 163045 | Russia |
| GBUZ of Nizhny Novgorod region Clinical diagnostic center | Nizhny Novgorod | Nizhny Novgorod Oblast | 603006 | Russia |
| GAUZ Republican clinical oncology dispensary of the Ministry | Kazan' | 420029 | Russia |
| Republic Clinical Oncology Despensary | Kazan' | 420029 | Russia |
| Medincentre (GLAVUPDK) | Moscow | 119034 | Russia |
| VitaMed LLC | Moscow | 121309 | Russia |
| MBUZ City Clinical Hospital #1 | Novosibirsk | Russia |
| Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary" | Omsk | 644013 | Russia |
| Private medical institution "Euromedservice" | Pushkin | 196603 | Russia |
| First St. Petersburg State Medical University n. a. Pavlov | Saint Petersburg | 197022 | Russia |
| LLC "Eurocityclinic" | Saint Petersburg | 197022 | Russia |
| Limited Liability Company "AV Medical Group" - Oncology | Saint Petersburg | 197082 | Russia |
| Saint-Petersburg City Clinical Oncology Dispensary | Saint Petersburg | 198255 | Russia |
| GBUZ "Regional clinical oncologic dispensary of Volgograd" | Volgograd | 400138 | Russia |
| Yaroslavl regional oncology hospital | Yaroslavl | 150054 | Russia |
| Clinical Hospital Center "Bezanijska Kosa" | Belgrade | Belgrade | 11080 | Serbia |
| Institute for Pulmonary Diseases of Vojvodina | Kamenitz | Vojvodina | 21204 | Serbia |
| Clinical Center Kragujevac | Kragujevac | 34000 | Serbia |
| National University Hospital | Singapore | 119074 | Singapore |
| The Catholic University of Korea, Bucheon St. Mary's Hospital | Bucheon-si | Gyeonggi-do | 14647 | South Korea |
| National Cancer Center | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| CHA Bundang Medical Center, CHA University | Seongnam-si | Gyeonggi-do | 13496 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| The Catholic University of Korea, St. Vincent's Hospital | Suwon | Gyeonggi-do | 16247 | South Korea |
| Ajou University Hospital | Suwon | Gyeonggi-do | 16499 | South Korea |
| Gyeongsang National University Hospital | Jinju | Gyeongsangnam-do | 52727 | South Korea |
| Chungbuk National University Hospital | Cheongju-si | North Chungcheong | 28644 | South Korea |
| Inje University Haeundae Paik Hospital | Busan | 48108 | South Korea |
| Yeungnam University Medical Center | Daegu | 42415 | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | 42601 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 03181 | South Korea |
| The Catholic University of Korea, Eunpyeong St.Mary's Hospital | Seoul | 03312 | South Korea |
| Severance Hospital | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | 06591 | South Korea |
| SMG-SNU Boramae Medical Center | Seoul | 07061 | South Korea |
| Ulsan University Hospital | Ulsan | 44033 | South Korea |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Ramathibodi Hospital, Mahidol University | Bangkok | 10400 | Thailand |
| Siriraj Hospital | Bangkok | 10700 | Thailand |
| Chiang Mai University - Faculty of Medicine | Chiang Mai | 50200 | Thailand |
| Prince of Songkla University | Hat Yai | 90110 | Thailand |
| Srinagarind Hospital, Khon Kaen University | Khon Kaen | 40002 | Thailand |
| Adana Baskent Practice and Research Hospital | Adana | 1120 | Turkey (Türkiye) |
| Cukurova University Medical Faculty | Adana | 1330 | Turkey (Türkiye) |
| Ankara Liv Hospital | Ankara | 06680 | Turkey (Türkiye) |
| Hacettepe University Medical Faculty - Medical Oncology | Ankara | 6230 | Turkey (Türkiye) |
| Trakya University Medical Faculty | Edirne | 22030 | Turkey (Türkiye) |
| Istanbul Medeniyet University Goztepe Training and Research Hospital - Medical Oncology | Istanbul | 34722 | Turkey (Türkiye) |
| Medical Point İzmir Hospital | Izmir | 35560 | Turkey (Türkiye) |
| Kocaeli University Medical Faculty | Kocaeli | 41380 | Turkey (Türkiye) |
| Inonu University Turgut Ozal Medical Center | Malatya | 44280 | Turkey (Türkiye) |
| Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady "Oblasnyi klinichnyi spetsializovanyi dyspanser radiatsiinoho zakhystu naselennia" - khirurhichne viddilennia | Kharkiv | Kharkiv Oblast | 61166 | Ukraine |
| Tsentralna miska klinichna likarnia | Uzhhorod | Zakarpattia Oblast | 88000 | Ukraine |
| Oblasne komunalne nekomertsiine pidpryiemstvo "Bukovynskyi klinichnyi onkolohichnyi tsentr", strukturnyi pidrozdil klinichnoi onkolohii, m.Chernivtsi | Chernivtsi | 58013 | Ukraine |
| Komunalne nekomertsiine pidpryiemstvo "Miska klinichna likarnia â„–4" Dniprvskoi miskoi rady", khimioterapevtychne viddilennia z dennym statsionarom, Derzhavnyi zaklad "Dnipropetrovskyi derzhavnyi medychnyi universitet", kafedra onkolohii i medychnoi radio | Dnipro | 49102 | Ukraine |
| Kyiv City Clinical Oncology Center - Department of Chemotherapy | Kyiv | 3115 | Ukraine |
| Komunalne nekomertsiine pidpryiemstvo Sumskoi oblasnoi rady "Sumskyi klinichnyi onkolohichnyi tsentr", onkotorakalne viddilennia, Sumskyi derzhavnyi universytet, kafedra onkolohii ta radiolohii, m. Sumy | Sumy | 40022 | Ukraine |
| Podilskyi rehionalnyi tsentr onkolohii, viddilennia khimioterapii | Vinnytsia | 21029 | Ukraine |
| Medychnyi tsentr Tovarystva z obmezhenoiu vidpovidalnistiu "Onkolaif" | Zaporizhzhia | 69059 | Ukraine |
| Derived |
| Cho BC, Ahn MJ, Kang JH, Soo RA, Reungwetwattana T, Yang JC, Cicin I, Kim DW, Wu YL, Lu S, Lee KH, Pang YK, Zimina A, Fong CH, Poddubskaya E, Sezer A, How SH, Danchaivijitr P, Kim Y, Lim Y, An T, Lee H, Byun HM, Zaric B. Lazertinib Versus Gefitinib as First-Line Treatment in Patients With EGFR-Mutated Advanced Non-Small-Cell Lung Cancer: Results From LASER301. J Clin Oncol. 2023 Sep 10;41(26):4208-4217. doi: 10.1200/JCO.23.00515. Epub 2023 Jun 28. |
| COMPLETED | Participants ongoing study treatment at data cut-off |
|
| NOT COMPLETED |
|
|
The full analysis set (FAS), FAS included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lazertinib 240 mg | Randomized participants received Lazertinib 240 mg orally once daily (QD) |
| BG001 | Gefitnib 250 mg | Randomized participants received Gefitinib 250 mg orally once daily (QD) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Smoking history | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS) According to RECIST v1.1 by Investigator Assessment | PFS was defined as the time from randomization until the date of objective progression or death(by any cause whichever comes first based on investigator assessment using RECIST v1.1 and was used to assess the efficacy of lazertinib compared to the gefitinib). | The full analysis set (FAS), FAS included all randomized participants. | Posted | Median | 95% Confidence Interval | Months | At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression, assessed up to 29 months per participant. |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) According to RECIST v1.1 by Investigator Assessments | ORR was defined as the percentage of participants with measurable disease with at least on visit response of complete response(CR) or Partial response(PR) and it was used to further assess the efficacy of lazertinib compared with gefitinib. | The full analysis set (FAS), FAS included all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression, assessed up to 29 months per participant. |
|
| |||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) According to RECIST v1.1 by Investigator Assessments | DoR was defined as the time from the date of first documented response(CR or PR) until the date of documented progression or death, whichever comes first and was used to further assess the efficacy of lazertinib compared with gefitinib. | The full analysis set (FAS), FAS included all randomized participants. | Posted | Median | 95% Confidence Interval | Months | At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression, assessed up to 29 months per participant. |
|
| |||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) According to RECIST v1.1 by Investigator Assessments | DCR was defined as the percentage of participants who have a best overall response of CR or PR or SD(SD at >= 6weeks prior to any PD event) and was used to further assess the efficacy of lazertinib compared with gefitinib. | The full analysis set (FAS), FAS included all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression, assessed up to 29 months per participant. |
|
| |||||||||||||||||||||||||||||
| Secondary | Depth of Response According to RECIST v1.1 by Investigator Assessments | The depth of response was defined as the best percent change in the sum of diameters of target lesions in the absense of new lesions or progression of non-target lesions compared to the baseline and was used to further assess the efficacy of lazertinib compared with gefitinib. | Not Posted | At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression. | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Time to Response According to RECIST v1.1 by Investigator Assessments | Time to Response was defined as the time from the date of randomization until the date of first documented response and was used to further assess the efficacy of lazertinib compared with gefitinib. | Not Posted | At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression. | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from the date of randomization until the date of death due to any cause and was used to further assess the efficacy of lazertinib compared with gefitinib. | The full analysis set (FAS), FAS included all randomized participants. | Posted | Count of Participants | Participants | From the randomization to end of study or date of death from any cause, whichever comes first, assessed every 6 weeks. (Up to 29 months per participant.) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of Lazertinib | To characterize the pharmacokinetics (PK) of lazertinib. | Not Posted | Blood samples collected from each participant at pre-dose, 1 to 3 hours, and 4 to 6 hours post-dose on Day 1 Cycle 1, Day 1 Cycle 2, Day 1 Cycle 5, Day 1 Cycle 9, and Day 1 Cycle 13. | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Cerebrospinal Fluid (CSF) Concentrations of Lazertinib | To characterize the pharmacokinetics (PK) of lazertinib. | Not Posted | A cerebrospinal fluid (CSF) sample once collected from participants with brain metastases, at Cycle 5 Day 1 or afterward. | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 Items (QLQ-C30) | The EORTC QLQ-C30 consists of 30 items and measures cancer participants' functioning (health related quality of life (HRQoL)) and symptoms for all cancer types. Questions can be grouped into 5 multi item functional scales (physical, role, emotional, cognitive, and social); 3 multi item symptom scales (fatigue, pain, nausea/vomiting); a 2 item global HRQoL scale; 5 single items assessing additional symptoms commonly reported by cancer participants (dyspnea, loss of appetite, insomnia, constipation, diarrhea) and 1 item on the financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
| Not Posted | Questionnaires completed at Cycle 1 Day1 , Cycle2 Day 1 and then every 6 weeks relative to the randomization date until 28d safety f/u or progression f/u visit(whichever is later). | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Lung Cancer 13 Items (EORTC QLQ-LC13) | The EORTC QLQ-LC13 includes questions assessing cough, hemoptysis, dyspnea, site specific pain (symptoms), sore mouth, dysphagia, peripheral neuropathy, and alopecia (treatment related side effects), and pain medication. The items on both measures were scaled and scored using the recommended EORTC procedures. Raw scores were transformed to a linear scale ranging from 0 to 100, with a higher score representing a higher level of functioning or higher level of symptoms. Provided at least half of the items in the scale were completed, the scale score was calculated using only those items for which values existed. | Not Posted | Questionnaires completed at Cycle 1 Day1 , Cycle2 Day 1 and then every 6 weeks relative to the randomization date until 28d safety f/u or progression f/u visit(whichever is later). | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Euro-Quality of Life-5 Dimension-5 Level (EQ-5D-5L) | The EQ-5D comprises the following two questionnaires:
| Not Posted | Questionnaires completed at Cycle 1 Day1 , Cycle2 Day 1 and then every 6 weeks relative to the randomization date until 28d safety f/u or progression f/u visit(whichever is later). | Participants |
All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued. (Up to 29 months per participant.)
An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lazertinib 240 mg | Randomized participants received Lazertinib 240 mg orally once daily (QD) | 49 | 196 | 51 | 196 | 189 | 196 |
| EG001 | Gefitnib 250 mg | Randomized participants received Gefitinib 250 mg orally once daily (QD) | 64 | 197 | 51 | 197 | 188 | 197 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Actinomycosis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Suspected COVID-19 | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
| |
| Malignant neoplasm of unknown primary site | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
| |
| Sinonasal papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Focal segmental glomerulosclerosis | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Thyroglossal cyst | Congenital, familial and genetic disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Paronychia | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 25.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dongmin Kim | Yuhan Corporation | +82-2-828-0523 | clinicaltrials@yuhan.co.kr |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 16, 2022 | Feb 15, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C000707992 | lazertinib |
| D000077156 | Gefitinib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Non-Asian |
|
| Former |
|
| Current |
|
|
|
|
|