search
Back to results

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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lazertinib 240 mg/160 mg
Gefitinib 250 mg
Lazertinib-matching placebo 240 mg/160 mg
Gefitinib-matching placebo 250 mg
Sponsored by
Yuhan Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Locally Advanced EGFR Sensitizing Mutation, Metastatic EGFR Sensitizing Mutation, EGFR TKI, Ex19del, L858R, First-line, YH25448, Advanced Non-Small Cell Lung Cancer, Adenocarcinoma of lung, Non-squamous carcinoma of lung, Phase III, Lazertinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Princess Alexandra Hospital
  • Eugenideio Therapeutirio - Ongcology Department
  • Attikon Hospital
  • Theageneio Anticancer Hospital of Thessaloniki
  • Debreceni Egyetem
  • Törökbálinti Tüdőgyógyintézet
  • Chungbuk National University Hospital
  • The Catholic University of Korea, Bucheon St. Mary's Hospital
  • National Cancer Center
  • CHA Bundang Medical Center, CHA University
  • Seoul National University Bundang Hospital
  • The Catholic University of Korea, St. Vincent's Hospital
  • Ajou University Hospital
  • Gyeongsang National University Hospital
  • Inje University Haeundae Paik Hospital
  • Yeungnam University Medical Center
  • Keimyung University Dongsan Medical Center
  • Gachon University Gil Medical Center
  • Korea University Anam Hospital
  • Seoul National University Hospital
  • Kangbuk Samsung Hospital
  • The Catholic University of Korea, Eunpyeong St.Mary's Hospital
  • Severance Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • SMG-SNU Boramae Medical Center
  • Ulsan University Hospital
  • Hospital Sultan Ismail
  • Hospital Raja Perempuan Zainab Ii
  • Hospital Tengku Ampuan Afzan
  • Hospital Pulau Pinang
  • Hospital Umum Sarawak
  • University Malaya Medical Centre
  • Manila Doctors Hospital - Clinical Trial Office
  • Perpetual Succour Hospital
  • Philippine General Hospital
  • Arkhangelsk Regional Clinical Oncological Dispensary
  • GBUZ of Nizhny Novgorod region Clinical diagnostic center
  • GAUZ Republican clinical oncology dispensary of the Ministry
  • Republic Clinical Oncology Despensary
  • Medincentre (GLAVUPDK)
  • VitaMed LLC
  • MBUZ City Clinical Hospital #1
  • Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"
  • Private medical institution "Euromedservice"
  • First St. Petersburg State Medical University n. a. Pavlov
  • LLC "Eurocityclinic"
  • Limited Liability Company "AV Medical Group" - Oncology
  • Saint-Petersburg City Clinical Oncology Dispensary
  • GBUZ "Regional clinical oncologic dispensary of Volgograd"
  • Yaroslavl regional oncology hospital
  • Institute for Pulmonary Diseases of Vojvodina
  • Clinical Hospital Center "Bezanijska Kosa"
  • National University Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Ramathibodi Hospital, Mahidol University
  • Siriraj Hospital
  • Chiang Mai University - Faculty of Medicine
  • Prince of Songkla University
  • Srinagarind Hospital, Khon Kaen University
  • Adana Baskent Practice and Research Hospital
  • Cukurova University Medical Faculty
  • Ankara Liv Hospital
  • Hacettepe University Medical Faculty - Medical Oncology
  • Trakya University Medical Faculty
  • Istanbul Medeniyet University Goztepe Training and Research Hospital - Medical Oncology
  • Medical Point İzmir Hospital
  • Kocaeli University Medical Faculty
  • Inonu University Turgut Ozal Medical Center
  • Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady "Oblasnyi klinichnyi spetsializovanyi dyspanser radiatsiinoho zakhystu naselennia" - khirurhichne viddilennia
  • Tsentralna miska klinichna likarnia
  • Oblasne komunalne nekomertsiine pidpryiemstvo "Bukovynskyi klinichnyi onkolohichnyi tsentr", strukturnyi pidrozdil klinichnoi onkolohii, m.Chernivtsi
  • 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 City Clinical Oncology Center - Department of Chemotherapy
  • Komunalne nekomertsiine pidpryiemstvo Sumskoi oblasnoi rady "Sumskyi klinichnyi onkolohichnyi tsentr", onkotorakalne viddilennia, Sumskyi derzhavnyi universytet, kafedra onkolohii ta radiolohii, m. Sumy
  • Podilskyi rehionalnyi tsentr onkolohii, viddilennia khimioterapii
  • Medychnyi tsentr Tovarystva z obmezhenoiu vidpovidalnistiu "Onkolaif"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lazertinib + Gefitinib-matching placebo

Gefitinib + Lazertinib-matching placebo

Arm Description

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 (250 mg orally, once daily) plus Lazertinib-matching placebo (240 mg or 160 mg orally, once daily) in accordance with the randomization schedule

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) according to RECIST v1.1 by Investigator assessment
To assess the efficacy of lazertinib compared with gefitinib as measured by PFS

Secondary Outcome Measures

Objective Response Rate (ORR) according to RECIST v1.1 by Investigator assessments
To further assess the efficacy of lazertinib compared with gefitinib
Duration of Response (DoR) according to RECIST v1.1 by Investigator assessments
To further assess the efficacy of lazertinib compared with gefitinib
Disease Control Rate (DCR) according to RECIST v1.1 by Investigator assessments
To further assess the efficacy of lazertinib compared with gefitinib
Depth of Response according to RECIST v1.1 by Investigator assessments
To further assess the efficacy of lazertinib compared with gefitinib
Time to Response according to RECIST v1.1 by Investigator assessments
To further assess the efficacy of lazertinib compared with gefitinib
Overall survival (OS)
To assess OS of lazertinib compared with gefitinib
Plasma concentrations of lazertinib
To characterize the pharmacokinetics (PK) of lazertinib
Cerebrospinal fluid (CSF) concentrations of lazertinib
To characterize the PK of lazertinib
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 patients' 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 patients (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
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.
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 patients 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.

Full Information

First Posted
January 14, 2020
Last Updated
September 5, 2023
Sponsor
Yuhan Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT04248829
Brief Title
Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 13, 2020 (Actual)
Primary Completion Date
July 29, 2022 (Actual)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Locally Advanced EGFR Sensitizing Mutation, Metastatic EGFR Sensitizing Mutation, EGFR TKI, Ex19del, L858R, First-line, YH25448, Advanced Non-Small Cell Lung Cancer, Adenocarcinoma of lung, Non-squamous carcinoma of lung, Phase III, Lazertinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
393 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lazertinib + Gefitinib-matching placebo
Arm Type
Experimental
Arm Description
Lazertinib (240 mg or 160 mg orally, once daily) plus Gefitinib-matching placebo (250 mg orally, once daily) in accordance with the randomization schedule
Arm Title
Gefitinib + Lazertinib-matching placebo
Arm Type
Active Comparator
Arm Description
Gefitinib (250 mg orally, once daily) plus Lazertinib-matching placebo (240 mg or 160 mg orally, once daily) in accordance with the randomization schedule
Intervention Type
Drug
Intervention Name(s)
Lazertinib 240 mg/160 mg
Other Intervention Name(s)
YH25448 240 mg/160 mg
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Gefitinib 250 mg
Other Intervention Name(s)
Iressa 250 mg
Intervention Description
The initial dose for Gefitinib (250 mg once daily) cannot be reduced to a lower dose
Intervention Type
Drug
Intervention Name(s)
Lazertinib-matching placebo 240 mg/160 mg
Other Intervention Name(s)
YH25448-matching placebo 240 mg/160 mg
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Gefitinib-matching placebo 250 mg
Other Intervention Name(s)
Iressa-matching placebo 250 mg
Intervention Description
The initial dose for Gefitinib-matching placebo (250 mg once daily) cannot be reduced to a lower dose
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) according to RECIST v1.1 by Investigator assessment
Description
To assess the efficacy of lazertinib compared with gefitinib as measured by PFS
Time Frame
The primary analysis of PFS based on investigator assessment will occur when PFS maturity is observed at approximately 27 months after the first patient is randomized
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR) according to RECIST v1.1 by Investigator assessments
Description
To further assess the efficacy of lazertinib compared with gefitinib
Time Frame
ORR analysis will occur when PFS maturity is observed at approximately 27 months from the first patient being randomized
Title
Duration of Response (DoR) according to RECIST v1.1 by Investigator assessments
Description
To further assess the efficacy of lazertinib compared with gefitinib
Time Frame
DoR analysis will occur when PFS maturity is observed at approximately 27 months from the first patient being randomized
Title
Disease Control Rate (DCR) according to RECIST v1.1 by Investigator assessments
Description
To further assess the efficacy of lazertinib compared with gefitinib
Time Frame
DCR analysis will occur when PFS maturity is observed at approximately 27 months from the first patient being randomized
Title
Depth of Response according to RECIST v1.1 by Investigator assessments
Description
To further assess the efficacy of lazertinib compared with gefitinib
Time Frame
Depth of Response analysis will occur when PFS maturity is observed at approximately 27 months from the first patient being randomized
Title
Time to Response according to RECIST v1.1 by Investigator assessments
Description
To further assess the efficacy of lazertinib compared with gefitinib
Time Frame
Time to Response analysis will occur when PFS maturity is observed at approximately 27 months from the first patient being randomized
Title
Overall survival (OS)
Description
To assess OS of lazertinib compared with gefitinib
Time Frame
OS will be analyzed at 2 time points: when PFS maturity is observed at approximately 27 months after the first patient is randomized, and when OS maturity is observed at approximately 45 months after the first patient is randomized
Title
Plasma concentrations of lazertinib
Description
To characterize the pharmacokinetics (PK) of lazertinib
Time Frame
Plasma concentration analysis will occur when PFS maturity is observed at approximately 27 months from the first patient being randomized
Title
Cerebrospinal fluid (CSF) concentrations of lazertinib
Description
To characterize the PK of lazertinib
Time Frame
CSF concentration analysis will occur when PFS maturity is observed at approximately 27 months from the first patient being randomized
Title
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 items (QLQ-C30)
Description
The EORTC QLQ-C30 consists of 30 items and measures cancer patients' 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 patients (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
Time Frame
EORTC-QLQ-C30 analysis will occur when OS maturity is observed at approximately 45 months from the first patient being randomized
Title
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Lung Cancer 13 items (EORTC QLQ-LC13)
Description
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.
Time Frame
EORTC QLQ-LC13 analysis will occur when OS maturity is observed at approximately 45 months from the first patient being randomized
Title
Change From Baseline in Euro-Quality of Life-5 Dimension-5 level (EQ-5D-5L)
Description
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 patients 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.
Time Frame
EQ-5D-5L analysis will occur when OS maturity is observed at approximately 45 months from the first patient being randomized
Other Pre-specified Outcome Measures:
Title
Intracranial PFS according to RECIST v1.1 by Investigator assessment and blinded independent central review (BICR)
Description
To assess the intracranial efficacy of lazertinib compared with gefitinib in only patients with brain metastases (BM) at baseline
Time Frame
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
Title
Intracranial ORR according to RECIST v1.1 by Investigator assessments and BICR
Description
To assess the intracranial efficacy of lazertinib compared with gefitinib in only patients with BM at baseline
Time Frame
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
Title
Intracranial DoR according to RECIST v1.1 by Investigator assessment and BICR
Description
To assess the intracranial efficacy of lazertinib compared with gefitinib in only patients with BM at baseline
Time Frame
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
Title
Intracranial DCR according to RECIST v1.1 by Investigator assessment and BICR
Description
To assess the intracranial efficacy of lazertinib compared with gefitinib in only patients with BM at baseline
Time Frame
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
Title
Depth of intracranial response according to RECIST v1.1 by Investigator assessment and BICR
Description
To assess the intracranial efficacy of lazertinib compared with gefitinib in only patients with BM at baseline
Time Frame
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
Title
Time to intracranial response according to RECIST v1.1 by Investigator assessment and BICR
Description
To assess the intracranial efficacy of lazertinib compared with gefitinib in only patients with BM at baseline
Time Frame
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
Title
PFS according to RECIST v1.1 by Investigator assessment
Description
To assess the efficacy of lazertinib in the cross-over arm
Time Frame
PFS analysis will occur when OS maturity is observed at approximately 45 months from the first dosing date of lazertinib
Title
ORR according to RECIST v1.1 by Investigator assessments
Description
To assess the efficacy of lazertinib in the cross-over arm
Time Frame
ORR analysis will occur when OS maturity is observed at approximately 45 months from the first patient being randomized
Title
DoR according to RECIST v1.1 by Investigator assessments
Description
To assess the efficacy of lazertinib in the cross-over arm
Time Frame
DoR analysis will occur when OS maturity is observed at approximately 45 months from the first patient being randomized
Title
DCR according to RECIST v1.1 by Investigator assessments
Description
To assess the efficacy of lazertinib in the cross-over arm
Time Frame
DCR analysis will occur when OS maturity is observed at approximately 45 months from the first patient being randomized
Title
Depth of Response according to RECIST v1.1 by Investigator assessments
Description
To assess the efficacy of lazertinib in the cross-over arm
Time Frame
Depth of Response analysis will occur when OS maturity is observed at approximately 45 months from the first patient being randomized
Title
Time to Response according to RECIST v1.1 by Investigator assessments
Description
To assess the efficacy of lazertinib in the cross-over arm
Time Frame
Time to Response analysis will occur when OS maturity is observed at approximately 45 months from the first patient being randomized
Title
Change from baseline for EGFR mutation status in plasma samples
Description
To compare plasma-derived cfDNA EGFR mutation status at baseline and at progression
Time Frame
EGFR mutation status in plasma samples analysis will occur when OS maturity is observed at approximately 45 months from the first patient being randomized
Title
Change from baseline for EGFR mutation status in tumor samples
Description
To compare the tumor sample EGFR mutation status at baseline and from an optional tumor sample taken at progression
Time Frame
EGFR mutation status in tumor samples analysis will occur when OS maturity is observed at approximately 45 months from the first patient being randomized

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

We'll reach out to this number within 24 hrs