Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301)

A Phase III, Randomized, Double-blind Study to Assess the Efficacy and Safety of Lazertinib Versus Gefitinib as the First-line Treatment in Patients With Epidermal Growth Factor Receptor Sensitizing Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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

Study Overview

• Status: Active, not recruiting
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Lazertinib 240 mg/160 mg; Drug: Gefitinib-matching placebo 250 mg; Drug: Gefitinib 250 mg; Drug: Lazertinib-matching placebo 240 mg/160 mg

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 393
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
• Greece
  • Athens, Greece, 11528
    • Eugenideio Therapeutirio - Ongcology Department
  • Athens, Greece, 12462
    • Attikon Hospital
  • Thessaloníki, Greece, 54007
    • Theageneio Anticancer Hospital of Thessaloniki
• Hungary
  • Debrecen, Hungary, H-4012
    • Debreceni Egyetem
  • Törökbálint, Hungary, 2045
    • Torokbalinti Tudogyogyintezet
• Korea, Republic of
  • Busan, Korea, Republic of, 48108
    • Inje University Haeundae Paik Hospital
  • Daegu, Korea, Republic of, 42415
    • Yeungnam University Medical Center
  • Daegu, Korea, Republic of, 42601
    • Keimyung University Dongsan Medical Center
  • Incheon, Korea, Republic of, 21565
    • Gachon University Gil Medical Center
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 03181
    • Kangbuk Samsung Hospital
  • Seoul, Korea, Republic of, 07061
    • SMG-SNU Boramae Medical Center
  • Seoul, Korea, Republic of, 03312
    • The Catholic University of Korea, Eunpyeong St.Mary's Hospital
  • Ulsan, Korea, Republic of, 44033
    • Ulsan University Hospital
  • Chungcheongbuk-do
    • Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 28644
      • Chungbuk National University Hospital
  • Gyeonggi-do
    • Bucheon-si, Gyeonggi-do, Korea, Republic of, 14647
      • The Catholic University of Korea, Bucheon St. Mary's Hospital
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
      • National Cancer Center
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
      • CHA Bundang Medical Center, CHA University
    • Suwon-si, Gyeonggi-do, Korea, Republic of, 16247
      • The Catholic University of Korea, St. Vincent'S Hospital
    • Suwon-si, Gyeonggi-do, Korea, Republic of, 16499
      • Ajou University Hospital
  • Gyeongsangnam-do
    • Jinju-si, Gyeongsangnam-do, Korea, Republic of, 52727
      • Gyeongsang National University Hospital
• Malaysia
  • Johor
    • Johor Bahru, Johor, Malaysia, 81100
      • Hospital Sultan Ismail
  • Kelantan
    • Kota Bahru, Kelantan, Malaysia, 15586
      • Hospital Raja Perempuan Zainab II
  • Pahang
    • Kuantan, Pahang, Malaysia, 25100
      • Hospital Tengku Ampuan Afzan
  • Pulau Pinang
    • George Town, Pulau Pinang, Malaysia, 10400
      • Hospital Pulau Pinang
  • Sarawak
    • Kuching, Sarawak, Malaysia, 10450
      • Hospital Umum Sarawak
  • Selangor
    • Kuala Lumpur, Selangor, Malaysia, 59100
      • University Malaya Medical Centre
• Philippines
  • Cebu, Philippines, 6000
    • Perpetual Succour Hospital
  • Manila, Philippines, 1000
    • Philippine General Hospital
  • Quezon
    • Manila, Quezon, Philippines, 1000
      • Manila Doctors Hospital - Clinical Trial Office
• Russian Federation
  • Kazan, Russian Federation, 420029
    • GAUZ Republican clinical oncology dispensary of the Ministry
  • Kazan, Russian Federation, 420029
    • Republic Clinical Oncology Despensary
  • Moscow, Russian Federation, 121309
    • VitaMed LLC
  • Moscow, Russian Federation, 119034
    • Medincentre (GLAVUPDK)
  • Novosibirsk, Russian Federation
    • MBUZ City Clinical Hospital #1
  • Omsk, Russian Federation, 644013
    • Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"
  • Pushkin, Russian Federation, 196603
    • Private medical institution "Euromedservice"
  • Saint Petersburg, Russian Federation, 198255
    • Saint-Petersburg City Clinical Oncology Dispensary
  • Saint Petersburg, Russian Federation, 197022
    • LLC "Eurocityclinic"
  • Saint Petersburg, Russian Federation, 197022
    • First St. Petersburg State Medical University n. a. Pavlov
  • Saint Petersburg, Russian Federation, 197082
    • Limited Liability Company "AV Medical Group" - Oncology
  • Volgograd, Russian Federation, 400138
    • GBUZ "Regional clinical oncologic dispensary of Volgograd"
  • Yaroslavl, Russian Federation, 150054
    • Yaroslavl regional oncology hospital
  • Arkhangel'skaya Oblast'
    • Arkhangel'sk, Arkhangel'skaya Oblast', Russian Federation, 163045
      • Arkhangelsk Regional Clinical Oncological Dispensary
  • Nizhegorodskaya Oblast'
    • Nizhny Novgorod, Nizhegorodskaya Oblast', Russian Federation, 603006
      • GBUZ of Nizhny Novgorod region Clinical diagnostic center
• Serbia
  • Belgrade, Serbia, 11080
    • Clinical Hospital Center "Bezanijska Kosa"
  • Kragujevac, Serbia, 34000
    • Clinical Center Kragujevac
  • Vojvodina
    • Sremska Kamenica, Vojvodina, Serbia, 21204
      • Institute For Pulmonary Diseases of Vojvodina
• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital
• Taiwan
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital, Mahidol University
  • Chiang Mai, Thailand, 50200
    • Chiang Mai University - Faculty of Medicine
  • Hat Yai, Thailand, 90110
    • Prince of Songkla University
  • Khon Kaen, Thailand, 40002
    • Srinagarind Hospital, Khon Kaen University
• Turkey
  • Adana, Turkey, 1120
    • Adana Baskent Practice and Research Hospital
  • Adana, Turkey, 1330
    • Cukurova University Medical Faculty
  • Ankara, Turkey, 06680
    • Ankara Liv Hospital
  • Ankara, Turkey, 6230
    • Hacettepe University Medical Faculty - Medical Oncology
  • Edirne, Turkey, 22030
    • Trakya University Medical Faculty
  • Istanbul, Turkey, 34722
    • Istanbul Medeniyet University Goztepe Training and Research Hospital - Medical Oncology
  • Kocaeli, Turkey, 41380
    • Kocaeli University Medical Faculty
  • Malatya, Turkey, 44280
    • Inonu University Turgut Ozal Medical Center
  • İzmir, Turkey, 35560
    • Medical Point Izmir Hospital
• Ukraine
  • Chernivtsi, Ukraine, 58013
    • Oblasne komunalne nekomertsiine pidpryiemstvo "Bukovynskyi klinichnyi onkolohichnyi tsentr", strukturnyi pidrozdil klinichnoi onkolohii, m.Chernivtsi
  • Dnipro, Ukraine, 49102
    • Komunalne nekomertsiine pidpryiemstvo "Miska klinichna likarnia №4" Dniprovskoi miskoi rady", khimioterapevtychne viddilennia z dennym statsionarom, Derzhavnyi zaklad "Dnipropetrovskyi derzhavnyi medychnyi universitet", kafedra onkolohii i medychnoi radio
  • Kyiv, Ukraine, 3115
    • Kyiv City Clinical Oncology Center - Department of Chemotherapy
  • Sumy, Ukraine, 40022
    • Komunalne nekomertsiine pidpryiemstvo Sumskoi oblasnoi rady "Sumskyi klinichnyi onkolohichnyi tsentr", onkotorakalne viddilennia, Sumskyi derzhavnyi universytet, kafedra onkolohii ta radiolohii, m. Sumy
  • Vinnytsia, Ukraine, 21029
    • Podilskyi rehionalnyi tsentr onkolohii, viddilennia khimioterapii
  • Zaporizhzhia, Ukraine, 69059
    • Medychnyi tsentr Tovarystva z obmezhenoiu vidpovidalnistiu "Onkolaif"
  • Kharkivs'ka Oblast'
    • Kharkiv, Kharkivs'ka Oblast', Ukraine, 61166
      • Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady "Oblasnyi klinichnyi spetsializovanyi dyspanser radiatsiinoho zakhystu naselennia" - khirurhichne viddilennia
  • Zakarpats'ka Oblast'
    • Úzhgorod, Zakarpats'ka Oblast', Ukraine, 88000
      • Tsentralna miska klinichna likarnia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pathologically confirmed adenocarcinoma of the lung
• Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy
• At least 1 of the 2 common EGFR mutations known to be associated with EGFR TKI sensitivity (Ex19del or L858R), either alone or in combination with other EGFR mutations
• Treatment-naïve for locally advanced or metastatic NSCLC
• WHO performance status score of 0 to 1 with no clinically significant deterioration over the previous 2 weeks before randomization
• At least 1 measurable lesion, not previously irradiated and not chosen for biopsy during the study Screening period

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:

  • History of symptomatic chronic heart failure or serious cardiac arrhythmia requiring active treatment
  • History of myocardial infarction or unstable angina within 24 weeks of randomization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lazertinib + Gefitinib-matching placebo; Lazertinib (240 mg or 160 mg orally, once daily) plus Gefitinib-matching placebo (250 mg orally, once daily) in accordance with the randomization schedule	Drug: Lazertinib 240 mg/160 mg; 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; Other Names: YH25448 240 mg/160 mg; Drug: Gefitinib-matching placebo 250 mg; The initial dose for Gefitinib-matching placebo (250 mg once daily) cannot be reduced to a lower dose; Other Names: Iressa-matching placebo 250 mg
Active Comparator: Gefitinib + Lazertinib-matching placebo; Gefitinib (250 mg orally, once daily) plus Lazertinib-matching placebo (240 mg or 160 mg orally, once daily) in accordance with the randomization schedule	Drug: Gefitinib 250 mg; The initial dose for Gefitinib (250 mg once daily) cannot be reduced to a lower dose; Other Names: Iressa 250 mg; Drug: Lazertinib-matching placebo 240 mg/160 mg; 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; Other Names: YH25448-matching placebo 240 mg/160 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.
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.; a high score for a functional scale represents a high / healthy level of functioning; a high score for the global health status / QoL represents a high QoL; but a high score for a symptom scale / item represents a high level of symptomatology / problems	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: The EQ-5D comprises 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension comprises five levels (no problems, slight problems, moderate problem, severe problem, unable/extreme problems).; The EQ VAS records the participants self-rated health status on a vertical graduated (0-100) visual analogue scale. The patient's self-rated health is assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) by the EQ-VAS.	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).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intracranial PFS according to RECIST v1.1 by Investigator assessment and blinded independent central review (BICR)	To assess the intracranial efficacy of lazertinib compared with gefitinib in only patients with brain metastases (BM) at baseline	Intracranial PFS based on Investigator assessment and BICR analysis will occur when PFS maturity is observed at approximately 27 months from the first patient being randomized
Intracranial ORR according to RECIST v1.1 by Investigator assessments and BICR	To assess the intracranial efficacy of lazertinib compared with gefitinib in only patients with BM at baseline	Intracranial ORR based on Investigator assessment and BICR analysis will occur when PFS maturity is observed at approximately 27 months from the first patient being randomized
Intracranial DoR according to RECIST v1.1 by Investigator assessment and BICR	To assess the intracranial efficacy of lazertinib compared with gefitinib in only patients with BM at baseline	Intracranial DoR based on Investigator assessment and BICR analysis will occur when PFS maturity is observed at approximately 27 months from the first patient being randomized
Intracranial DCR according to RECIST v1.1 by Investigator assessment and BICR	To assess the intracranial efficacy of lazertinib compared with gefitinib in only patients with BM at baseline	Intracranial DCR based on Investigator assessment and BICR analysis will occur when PFS maturity is observed at approximately 27 months from the first patient being randomized
Depth of intracranial response according to RECIST v1.1 by Investigator assessment and BICR	To assess the intracranial efficacy of lazertinib compared with gefitinib in only patients with BM at baseline	Depth of intracranial response based on Investigator assessment and BICR analysis will occur when PFS maturity is observed at approximately 27 months from the first patient being randomized
Time to intracranial response according to RECIST v1.1 by Investigator assessment and BICR	To assess the intracranial efficacy of lazertinib compared with gefitinib in only patients with BM at baseline	Time to intracranial response analysis based on Investigator assessment and BICR will occur when PFS maturity is observed at approximately 27 months from the first patient being randomized
PFS according to RECIST v1.1 by Investigator assessment	To assess the efficacy of lazertinib in the cross-over arm	PFS analysis will occur when OS maturity is observed at approximately 45 months from the first dosing date of lazertinib
ORR according to RECIST v1.1 by Investigator assessments	To assess the efficacy of lazertinib in the cross-over arm	ORR analysis will occur when OS maturity is observed at approximately 45 months from the first patient being randomized
DoR according to RECIST v1.1 by Investigator assessments	To assess the efficacy of lazertinib in the cross-over arm	DoR analysis will occur when OS maturity is observed at approximately 45 months from the first patient being randomized
DCR according to RECIST v1.1 by Investigator assessments	To assess the efficacy of lazertinib in the cross-over arm	DCR analysis will occur when OS maturity is observed at approximately 45 months from the first patient being randomized
Depth of Response according to RECIST v1.1 by Investigator assessments	To assess the efficacy of lazertinib in the cross-over arm	Depth of Response analysis will occur when OS maturity is observed at approximately 45 months from the first patient being randomized
Time to Response according to RECIST v1.1 by Investigator assessments	To assess the efficacy of lazertinib in the cross-over arm	Time to Response analysis will occur when OS maturity is observed at approximately 45 months from the first patient being randomized
Change from baseline for EGFR mutation status in plasma samples	To compare plasma-derived cfDNA EGFR mutation status at baseline and at progression	EGFR mutation status in plasma samples analysis will occur when OS maturity is observed at approximately 45 months from the first patient being randomized
Change from baseline for EGFR mutation status in tumor samples	To compare the tumor sample EGFR mutation status at baseline and from an optional tumor sample taken at progression	EGFR mutation status in tumor samples analysis will occur when OS maturity is observed at approximately 45 months from the first patient being randomized

Collaborators and Investigators

• Sponsor: Yuhan Corporation

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2020
• Primary Completion (Actual): July 29, 2022
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: January 14, 2020
• First Submitted That Met QC Criteria: January 28, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Phase III; First-line; EGFR TKI; Lazertinib; Advanced Non-Small Cell Lung Cancer; Locally Advanced EGFR Sensitizing Mutation; Metastatic EGFR Sensitizing Mutation; Ex19del; L858R; YH25448; Adenocarcinoma of lung; Non-squamous carcinoma of lung
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Tyrosine Kinase Inhibitors; Gefitinib; Lazertinib
• Other Study ID Numbers: YH25448-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: Beginning 1 year and ending 5 years after all trial primary and secondary endpoints were assessed.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes