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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04248829




Registration number
NCT04248829
Ethics application status
Date submitted
14/01/2020
Date registered
30/01/2020

Titles & IDs
Public title
Clinical Trial of YH25448(Lazertinib) as the First-line Treatment in Patients With EGFR Mutation Positive Locally Advanced or Metastatic NSCLC (LASER301)
Scientific 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
Secondary ID [1] 0 0
YH25448-301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lazertinib 240 mg/160 mg
Treatment: Drugs - Gefitinib 250 mg
Treatment: Drugs - Lazertinib-matching placebo 240 mg/160 mg
Treatment: Drugs - Gefitinib-matching placebo 250 mg

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

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


Treatment: Drugs: 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

Treatment: Drugs: Gefitinib 250 mg
The initial dose for Gefitinib (250 mg once daily) cannot be reduced to a lower dose

Treatment: Drugs: 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

Treatment: Drugs: Gefitinib-matching placebo 250 mg
The initial dose for Gefitinib-matching placebo (250 mg once daily) cannot be reduced to a lower dose
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) According to RECIST v1.1 by Investigator Assessment
Timepoint [1] 0 0
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 [1] 0 0
Objective Response Rate (ORR) According to RECIST v1.1 by Investigator Assessments
Timepoint [1] 0 0
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 [2] 0 0
Duration of Response (DoR) According to RECIST v1.1 by Investigator Assessments
Timepoint [2] 0 0
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 [3] 0 0
Disease Control Rate (DCR) According to RECIST v1.1 by Investigator Assessments
Timepoint [3] 0 0
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 [4] 0 0
Depth of Response According to RECIST v1.1 by Investigator Assessments
Timepoint [4] 0 0
At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression.
Secondary outcome [5] 0 0
Time to Response According to RECIST v1.1 by Investigator Assessments
Timepoint [5] 0 0
At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomization until progression.
Secondary outcome [6] 0 0
Overall Survival (OS)
Timepoint [6] 0 0
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 outcome [7] 0 0
Plasma Concentrations of Lazertinib
Timepoint [7] 0 0
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.
Secondary outcome [8] 0 0
Cerebrospinal Fluid (CSF) Concentrations of Lazertinib
Timepoint [8] 0 0
A cerebrospinal fluid (CSF) sample once collected from participants with brain metastases, at Cycle 5 Day 1 or afterward.
Secondary outcome [9] 0 0
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 Items (QLQ-C30)
Timepoint [9] 0 0
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).
Secondary outcome [10] 0 0
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Lung Cancer 13 Items (EORTC QLQ-LC13)
Timepoint [10] 0 0
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).
Secondary outcome [11] 0 0
Change From Baseline in Euro-Quality of Life-5 Dimension-5 Level (EQ-5D-5L)
Timepoint [11] 0 0
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).

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
Accrual to date
Final
393
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Greece
State/province [1] 0 0
Athens
Country [2] 0 0
Greece
State/province [2] 0 0
Thessaloníki
Country [3] 0 0
Hungary
State/province [3] 0 0
Debrecen
Country [4] 0 0
Hungary
State/province [4] 0 0
Törökbálint
Country [5] 0 0
Korea, Republic of
State/province [5] 0 0
Chungcheongbuk-do
Country [6] 0 0
Korea, Republic of
State/province [6] 0 0
Gyeonggi-do
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Gyeongsangnam-do
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Busan
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Daegu
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Incheon
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Seoul
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Ulsan
Country [13] 0 0
Malaysia
State/province [13] 0 0
Johor
Country [14] 0 0
Malaysia
State/province [14] 0 0
Kelantan
Country [15] 0 0
Malaysia
State/province [15] 0 0
Pahang
Country [16] 0 0
Malaysia
State/province [16] 0 0
Pulau Pinang
Country [17] 0 0
Malaysia
State/province [17] 0 0
Sarawak
Country [18] 0 0
Malaysia
State/province [18] 0 0
Selangor
Country [19] 0 0
Philippines
State/province [19] 0 0
Quezon
Country [20] 0 0
Philippines
State/province [20] 0 0
Cebu
Country [21] 0 0
Philippines
State/province [21] 0 0
Manila
Country [22] 0 0
Russian Federation
State/province [22] 0 0
Arkhangel'skaya Oblast'
Country [23] 0 0
Russian Federation
State/province [23] 0 0
Nizhegorodskaya Oblast'
Country [24] 0 0
Russian Federation
State/province [24] 0 0
Kazan
Country [25] 0 0
Russian Federation
State/province [25] 0 0
Moscow
Country [26] 0 0
Russian Federation
State/province [26] 0 0
Novosibirsk
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Omsk
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Pushkin
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Saint Petersburg
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Volgograd
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Yaroslavl
Country [32] 0 0
Serbia
State/province [32] 0 0
Vojvodina
Country [33] 0 0
Serbia
State/province [33] 0 0
Belgrade
Country [34] 0 0
Serbia
State/province [34] 0 0
Kragujevac
Country [35] 0 0
Singapore
State/province [35] 0 0
Singapore
Country [36] 0 0
Taiwan
State/province [36] 0 0
Taipei
Country [37] 0 0
Thailand
State/province [37] 0 0
Bangkok
Country [38] 0 0
Thailand
State/province [38] 0 0
Chiang Mai
Country [39] 0 0
Thailand
State/province [39] 0 0
Hat Yai
Country [40] 0 0
Thailand
State/province [40] 0 0
Khon Kaen
Country [41] 0 0
Turkey
State/province [41] 0 0
Adana
Country [42] 0 0
Turkey
State/province [42] 0 0
Ankara
Country [43] 0 0
Turkey
State/province [43] 0 0
Edirne
Country [44] 0 0
Turkey
State/province [44] 0 0
Istanbul
Country [45] 0 0
Turkey
State/province [45] 0 0
Izmir
Country [46] 0 0
Turkey
State/province [46] 0 0
Kocaeli
Country [47] 0 0
Turkey
State/province [47] 0 0
Malatya
Country [48] 0 0
Ukraine
State/province [48] 0 0
Kharkivs'ka Oblast'
Country [49] 0 0
Ukraine
State/province [49] 0 0
Zakarpats'ka Oblast'
Country [50] 0 0
Ukraine
State/province [50] 0 0
Chernivtsi
Country [51] 0 0
Ukraine
State/province [51] 0 0
Dnipro
Country [52] 0 0
Ukraine
State/province [52] 0 0
Kyiv
Country [53] 0 0
Ukraine
State/province [53] 0 0
Sumy
Country [54] 0 0
Ukraine
State/province [54] 0 0
Vinnytsia
Country [55] 0 0
Ukraine
State/province [55] 0 0
Zaporizhzhia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Yuhan Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 [email protected].

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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Beginning 1 year and ending 5 years after all trial primary and secondary endpoints were assessed.
Available to whom?
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 [email protected].
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04248829