NCT05338619

Brief Summary

The "PACIFIC" trial confirmed that the consolidation therapy with durvalumab in patients with stage III, locally advanced, unresectable NSCLC that had not progressed after definitive platinum-based chemoradiation therapy improved the progression-free survival (PFS) by about 17 months. However, in PACIFIC, no significant differences between durvalumab and placebo were observed in PFS. Unmet need remains in development of successful consolidation therapy following chemoradiation therapy in patients with EGFR-mutant stage III unresectable NSCLC. A recent "ADAURA" study showed that Osimertinib as an adjuvant therapy after surgery significantly prolonged disease-free survival in EGFR mutation-positive patients. Lazertinib, like Osimertinib, is a third-generation EGFR TKI agent and has shown excellent anticancer effects in preclinical studies and in early clinical settings. Based on these results of the 3rd generation EGFR TKI, Lazertinib, it is expected that there is a clinical benefit Lazertinib as consolidation therapy. This study aims to investigate the clinical benefits of Lazertinib (Trade name: LECLAZA Tab) consolidation therapy for patients with EGFR mutation-positive, unresectable stage III NSCLC after definitive platinum-based chemoradiation therapy.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
77

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2022

Typical duration for phase_2

Geographic Reach
1 country

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 30, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2026

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

3.7 years

First QC Date

April 14, 2022

Last Update Submit

August 31, 2023

Conditions

Non-small Cell Lung Cancer Stage IIIEGFR Positive Non-small Cell Lung CancerNon-squamous Non-small-cell Lung Cancer

Keywords

NSCLCNon-squamous cell carcinomaEGFREGFR-TKILazertinib

Outcome Measures

Primary Outcomes (1)

  • Progression free survival (PFS)

    The time from the date of enrollment until the date of disease progression or death (by any cause in the absence of progression) Per RECIST 1.1 as assessed by Investigator.

    Tumor scan will be performed at baseline the every 8 weeks until confirmed disease progression (up to 4 years)

Secondary Outcomes (5)

  • Overall survival (OS)

    Until death (up to maximum of approximately 4 years)

  • Objective response rate (ORR)

    Tumor scan will be performed at baseline the every 8 weeks until confirmed disease progression (up to 4 years)

  • Duration of response (DoR) Duration of response (DoR)

    Tumor scan will be performed at baseline the every 8 weeks until confirmed disease progression (up to 4 years)

  • Time to death or distant metastasis (TTDM)

    Until death or distant metastasis (up to maximum of approximately 4 years)

  • Safety profile : Adverse Events according to CTCAE V5.0

    every visit (up to maximum of approximately 4 years)

Other Outcomes (1)

  • Changes form baseline in different biomarkers

    Pre-dose(within 6 week of completion of CCRT), after 8-week dosing, and confirmed disease progression (approximately 15 months)

Study Arms (1)

Lazertinib

EXPERIMENTAL

Lazertinib 240mg, oral, QD

Drug: Lazertinib

Interventions

LazertinibDRUG

Lazertinib 240mg (3 Tabs as Laclaza Tab 80mg) once daily in oral can continue until disease progression, unacceptable toxicity or other discontinuation criteria are met.

Also known as: LECLAZA
Lazertinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older
  • Histologically and cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) non-squamous cell carcinoma who present with locally advanced, unresectable, Stage III disease
  • ECOG PS 0,1
  • Expected life expectancy of 6 months and more
  • Patients who have received at least 2 cycles of definitive platinum-based concurrent chemoradiation therapy (CCRT) and who must be within 1 to 42 days after completion of radiation therapy
  • Patients must not have had disease progression during or following CCRT
  • Patients with adequate organ and bone marrow function
  • Patients who give in written consent voluntarily to participate in this study

You may not qualify if:

  • History of interstitial lung disease, drug-induced interstitial lung disease, or radiation interstitial pneumonia
  • History of other primary malignancy
  • Mixed small cell and NSCLC histology
  • Prior treatment with EGFR-TKI Therapy
  • Unresolved toxicity of CTCAE grade 2 or higher following chemoradiation
  • Current history of CTCAE grade 2 or higher pneumonia prior to chemoradiation therapy
  • Patients with severe hypersensitivity to active ingredient or excipient of the investigational medicinal product
  • Pregnant or breastfeeding patients
  • Patients who do not agree to contraception with medically acceptable method for at least 6 months after the end of study intervention treatment
  • Patients who participated in clinical trials within 4 weeks before participating in this study
  • Judgment by the investigator that the patient is unsuitable to participate in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Kosin University Gospel Hospital

Busan, South Korea

RECRUITING

Keimyung University Dongsan Hospital

Daegu, South Korea

RECRUITING

Kyungpook National University Medical Center

Daegu, South Korea

RECRUITING

Chungnam National University Hospital

Daejeon, South Korea

RECRUITING

Chonnam National University Hospital Hwasun Hospital

Gwangju, South Korea

RECRUITING

Inha University Hospital

Incheon, South Korea

RECRUITING

Pusan National University Yangsan Hospital

Pusan, South Korea

RECRUITING

Asan Medical Center

Seoul, South Korea

RECRUITING

Hanyang University Seoul Hospital

Seoul, South Korea

RECRUITING

Koera University Guro Hospital

Seoul, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, South Korea

RECRUITING

Kyung Hee University Hospital

Seoul, South Korea

RECRUITING

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

Related Publications (2)

  • Choi J, Lee JE, Choi CM, Oh IJ, Lee KY, Jang TW, Lee SH, Kim EY, Park DW, Park SH, Lee SY. A phase II, multicenter study of lazertinib as consolidation therapy in patients with locally advanced, unresectable, EGFR mutation-positive non-small cell lung cancer (stage III) who have not progressed following definitive, platinum-based, chemoradiation therapy (PLATINUM trial). Thorac Cancer. 2022 Dec;13(23):3431-3435. doi: 10.1111/1759-7714.14663. Epub 2022 Oct 19.

    PMID: 36259253BACKGROUND

  • Wang W, Wang Q, Xu C, Li Z, Song Z, Zhang Y, Cai X, Zhang S, Lian B, Li W, Liu A, Zhan P, Liu H, Lv T, Miao L, Min L, Chen Y, Yuan J, Wang F, Jiang Z, Lin G, Pu X, Rao C, Lv D, Yu Z, Li X, Tang C, Zhou C, Xie C, Zhang J, Guo H, Chu Q, Meng R, Wu J, Zhang R, Wang L, Zhu Y, Hu X, Xie Y, Lin X, Cai J, Lan F, Feng H, Wang L, Yao W, Shi X, Huang J, Chen H, Zhang Y, Sun P, Wan B, Pang F, Xu Z, Wang K, Xia Y, Ye M, Wang D, Wei Q, Feng S, Zhou J, Zhang J, Lv D, Gao W, Kang J, Yu G, Liang X, Yu C, Shi L, Yang N, Wu L, Hong Z, Hong W, Fang M, Zhang Y, Lu Y, Wang G, Ma S, Si L, Fang W, Song Y. Chinese expert consensus on the multidisciplinary management of pneumonitis associated with immune checkpoint inhibitor. Thorac Cancer. 2022 Dec;13(23):3420-3430. doi: 10.1111/1759-7714.14693. Epub 2022 Oct 21.

    PMID: 36268845DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

lazertinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Sung Yong Lee, MD, PhD

    Korea University Guro Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung Yong Lee

CONTACT

82 2 2626 1914syl0801@korea.ac.kr

Youngsun Cho

CONTACT

82 70 4820 0249choyoungsun@procuratio.kr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Lazertinib treatment group (open-label)
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 14, 2022

First Posted

April 21, 2022

Study Start

June 30, 2022

Primary Completion

March 2, 2026

Study Completion

March 2, 2026

Last Updated

September 1, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(13)