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Clinical Trials List

Protocol NumberYH25448-301
NCT Number(ClinicalTrials.gov Identfier)NCT04248829

2020-09-15 - 2024-03-29

Phase III

Recruiting6

Terminated1

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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

  • Trial Applicant

    PAREXEL INTERNATIONAL CO., LTD.

  • Sponsor

    Yuhan Corporation

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator 林孟志 Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Ta Yang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yuh-Min Chen Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Chung Lin Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Gee-chen Chang Division of Thoracic Medicine
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Te-Chun Hsia Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Epidermal Growth Factor Receptor Sensitizing Mutation Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Objectives

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.

Test Drug

Lazertinib

Active Ingredient

Lazertinib Mesylate

Dosage Form

oral tablet

Dosage

93.86 mg (e.q. to lazertinib 80 mg)

Endpoints

Primary Outcome Measures :
Progression-Free Survival (PFS) according to RECIST v1.1 by Investigator assessment [ 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 ]
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 [ Time Frame: ORR analysis will occur when PFS maturity is observed at approximately 27 months from the first patient being randomized ]
To further assess the efficacy of lazertinib compared with gefitinib

Duration of Response (DoR) according to RECIST v1.1 by Investigator assessments [ Time Frame: DoR analysis will occur when PFS maturity is observed at approximately 27 months from the first patient being randomized ]
To further assess the efficacy of lazertinib compared with gefitinib

Disease Control Rate (DCR) according to RECIST v1.1 by Investigator assessments [ Time Frame: DCR analysis will occur when PFS maturity is observed at approximately 27 months from the first patient being randomized ]
To further assess the efficacy of lazertinib compared with gefitinib

Depth of Response according to RECIST v1.1 by Investigator assessments [ Time Frame: Depth of Response analysis will occur when PFS maturity is observed at approximately 27 months from the first patient being randomized ]
To further assess the efficacy of lazertinib compared with gefitinib

Time to Response according to RECIST v1.1 by Investigator assessments [ Time Frame: Time to Response analysis will occur when PFS maturity is observed at approximately 27 months from the first patient being randomized ]
To further assess the efficacy of lazertinib compared with gefitinib

Overall survival (OS) [ 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 ]
To assess OS of lazertinib compared with gefitinib

Plasma concentrations of lazertinib [ Time Frame: Plasma concentration analysis will occur when PFS maturity is observed at approximately 27 months from the first patient being randomized ]
To characterize the pharmacokinetics (PK) of lazertinib

Plasma concentrations of Metabolite YH26334 [ Time Frame: Plasma concentration analysis will occur when PFS maturity is observed at approximately 27 months from the first patient being randomized ]
To characterize the PK of lazertinib metabolite YH26334

Ratio of YH26334 to lazertinib plasma concentration [ Time Frame: Ratio of YH26334 to lazertinib plasma concentration analysis will occur when PFS maturity is observed at approximately 27 months from the first patient being randomized ]
To characterize the PK of lazertinib and YH26334

Cerebrospinal fluid (CSF) concentrations of lazertinib [ Time Frame: CSF concentration analysis will occur when PFS maturity is observed at approximately 27 months from the first patient being randomized ]
To characterize the PK of lazertinib

CSF concentrations of Metabolite YH26334 [ Time Frame: CSF concentration analysis will occur when PFS maturity is observed at approximately 27 months from the first patient being randomized ]
To characterize the PK of lazertinib metabolite YH26334

Ratio of CSF to plasma concentration of lazertinib and YH26334 [ Time Frame: Ratio of CSF to plasma concentration analysis will occur when PFS maturity is observed at approximately 27 months from the first patient being randomized ]
To characterize the PK of lazertinib and YH26334

Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 items (QLQ-C30) [ Time Frame: EORTC-QLQ-C30 analysis will occur when OS maturity is observed at approximately 45 months from the first patient being randomized ]
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) [ Time Frame: EORTC QLQ-LC13 analysis will occur when OS maturity is observed at approximately 45 months from the first patient being randomized ]
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) [ Time Frame: EQ-5D-5L analysis will occur when OS maturity is observed at approximately 45 months from the first patient being randomized ]
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.


Other Outcome Measures:
Intracranial PFS according to RECIST v1.1 by Investigator assessment and blinded independent central review (BICR) [ 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 ]
To assess the intracranial efficacy of lazertinib compared with gefitinib in only patients with brain metastases (BM) at baseline

Intracranial ORR according to RECIST v1.1 by Investigator assessments and BICR [ 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 ]
To assess the intracranial efficacy of lazertinib compared with gefitinib in only patients with BM at baseline

Intracranial DoR according to RECIST v1.1 by Investigator assessment and BICR [ 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 ]
To assess the intracranial efficacy of lazertinib compared with gefitinib in only patients with BM at baseline

Intracranial DCR according to RECIST v1.1 by Investigator assessment and BICR [ 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 ]
To assess the intracranial efficacy of lazertinib compared with gefitinib in only patients with BM at baseline

Depth of intracranial response according to RECIST v1.1 by Investigator assessment and BICR [ 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 ]
To assess the intracranial efficacy of lazertinib compared with gefitinib in only patients with BM at baseline

Time to intracranial response according to RECIST v1.1 by Investigator assessment and BICR [ 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 ]
To assess the intracranial efficacy of lazertinib compared with gefitinib in only patients with BM at baseline

PFS according to RECIST v1.1 by Investigator assessment [ Time Frame: PFS analysis will occur when OS maturity is observed at approximately 45 months from the first dosing date of lazertinib ]
To assess the efficacy of lazertinib in the cross-over arm

ORR according to RECIST v1.1 by Investigator assessments [ Time Frame: ORR analysis will occur when OS maturity is observed at approximately 45 months from the first patient being randomized ]
To assess the efficacy of lazertinib in the cross-over arm

DoR according to RECIST v1.1 by Investigator assessments [ Time Frame: DoR analysis will occur when OS maturity is observed at approximately 45 months from the first patient being randomized ]
To assess the efficacy of lazertinib in the cross-over arm

DCR according to RECIST v1.1 by Investigator assessments [ Time Frame: DCR analysis will occur when OS maturity is observed at approximately 45 months from the first patient being randomized ]
To assess the efficacy of lazertinib in the cross-over arm

Depth of Response according to RECIST v1.1 by Investigator assessments [ Time Frame: Depth of Response analysis will occur when OS maturity is observed at approximately 45 months from the first patient being randomized ]
To assess the efficacy of lazertinib in the cross-over arm

Time to Response according to RECIST v1.1 by Investigator assessments [ Time Frame: Time to Response analysis will occur when OS maturity is observed at approximately 45 months from the first patient being randomized ]
To assess the efficacy of lazertinib in the cross-over arm

Change from baseline for EGFR mutation status in plasma samples [ 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 ]
To compare plasma-derived cfDNA EGFR mutation status at baseline and at progression

Change from baseline for EGFR mutation status in tumor samples [ 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 ]
To compare the tumor sample EGFR mutation status at baseline and from an optional tumor sample taken at progression

Inclution 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

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

The Estimated Number of Participants

  • Taiwan

    25 participants

  • Global

    380 participants

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