search
Back to results

A Study of Lazertinib as Consolidation Therapy in Patients With Locally Advanced, Unresectable, EGFR-Mutant Non-Small Cell Lung Cancer (Stage III) Following Chemoradiation Therapy (PLATINUM)

Primary Purpose

Non-small Cell Lung Cancer Stage III, EGFR Positive Non-small Cell Lung Cancer, Non-squamous Non-small-cell Lung Cancer

Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lazertinib
Sponsored by
Sung Yong Lee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer Stage III focused on measuring NSCLC, Non-squamous cell carcinoma, EGFR, EGFR-TKI, Lazertinib

Eligibility Criteria

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

Inclusion Criteria:

  1. 18 years and older
  2. 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
  3. ECOG PS 0,1
  4. Expected life expectancy of 6 months and more
  5. 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
  6. Patients must not have had disease progression during or following CCRT
  7. Patients with adequate organ and bone marrow function
  8. Patients who give in written consent voluntarily to participate in this study

Exclusion Criteria:

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

Sites / Locations

  • Kosin University Gospel HospitalRecruiting
  • Keimyung University Dongsan HospitalRecruiting
  • Kyungpook National University Medical CenterRecruiting
  • Chungnam National University HospitalRecruiting
  • Chonnam National University Hospital Hwasun HospitalRecruiting
  • Inha University HospitalRecruiting
  • Pusan National University Yangsan HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Hanyang University Seoul HospitalRecruiting
  • Koera University Guro HospitalRecruiting
  • Korea University Anam HospitalRecruiting
  • Kyung Hee University HospitalRecruiting
  • Yonsei University Health System, Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lazertinib

Arm Description

Lazertinib 240mg, oral, QD

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall survival (OS)
The time from the date of enrollment until the date of death
Objective response rate (ORR)
The number (%) of patient at least 1 visit response of Complete response (CR) or Partial response (PR). Per RECIST 1.1 as assessed by Investigator.
Duration of response (DoR) Duration of response (DoR)
The time from the date of first documented response until the first date of documented progression (or death in the absence of disease progression) Per RECIST 1.1 as assessed by Investigator.
Time to death or distant metastasis (TTDM)
The time from the date of enrollment until the first date of distant metastasis or death in the absence of distant metastasis. Per RECIST 1.1 as assessed by Investigator.
Safety profile : Adverse Events according to CTCAE V5.0
Adverse events, Serious adverse events or other significant safety findings

Full Information

First Posted
April 14, 2022
Last Updated
August 31, 2023
Sponsor
Sung Yong Lee
Collaborators
Yuhan Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT05338619
Brief Title
A Study of Lazertinib as Consolidation Therapy in Patients With Locally Advanced, Unresectable, EGFR-Mutant Non-Small Cell Lung Cancer (Stage III) Following Chemoradiation Therapy
Acronym
PLATINUM
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2022 (Actual)
Primary Completion Date
March 2, 2026 (Anticipated)
Study Completion Date
March 2, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sung Yong Lee
Collaborators
Yuhan Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This study is designed as a prospective, open-label, single-arm, multicenter, phase II, investigator-initiated trial. A total of 77 patients will participate in the study who have undergone definitive platinum-based concurrent chemoradiation therapy and have no disease progression. Patients are to be enrolled within 1 to 42 days after concurrent chemoradiation therapy and to be administrated with lazertinib 240mg oral once daily until disease progression, or unacceptable toxicity. Patients will visit every 8 weeks and perform CT/MRI tumor evaluation by investigator, and will be followed up for survival every 3 months by phone thereafter. Patients will be followed up till maximum of appropriately 4 years of which 3 years since the last patient enrollment must be.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer Stage III, EGFR Positive Non-small Cell Lung Cancer, Non-squamous Non-small-cell Lung Cancer
Keywords
NSCLC, Non-squamous cell carcinoma, EGFR, EGFR-TKI, Lazertinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Lazertinib treatment group (open-label)
Masking
None (Open Label)
Allocation
N/A
Enrollment
77 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lazertinib
Arm Type
Experimental
Arm Description
Lazertinib 240mg, oral, QD
Intervention Type
Drug
Intervention Name(s)
Lazertinib
Other Intervention Name(s)
LECLAZA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
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.
Time Frame
Tumor scan will be performed at baseline the every 8 weeks until confirmed disease progression (up to 4 years)
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
The time from the date of enrollment until the date of death
Time Frame
Until death (up to maximum of approximately 4 years)
Title
Objective response rate (ORR)
Description
The number (%) of patient at least 1 visit response of Complete response (CR) or Partial response (PR). Per RECIST 1.1 as assessed by Investigator.
Time Frame
Tumor scan will be performed at baseline the every 8 weeks until confirmed disease progression (up to 4 years)
Title
Duration of response (DoR) Duration of response (DoR)
Description
The time from the date of first documented response until the first date of documented progression (or death in the absence of disease progression) Per RECIST 1.1 as assessed by Investigator.
Time Frame
Tumor scan will be performed at baseline the every 8 weeks until confirmed disease progression (up to 4 years)
Title
Time to death or distant metastasis (TTDM)
Description
The time from the date of enrollment until the first date of distant metastasis or death in the absence of distant metastasis. Per RECIST 1.1 as assessed by Investigator.
Time Frame
Until death or distant metastasis (up to maximum of approximately 4 years)
Title
Safety profile : Adverse Events according to CTCAE V5.0
Description
Adverse events, Serious adverse events or other significant safety findings
Time Frame
every visit (up to maximum of approximately 4 years)
Other Pre-specified Outcome Measures:
Title
Changes form baseline in different biomarkers
Description
Biomarker evaluations include tumor-educated platelets (TFP), circulating tumor DNA(ctDNA), and peripheral blood mononuclear cells (PMBCs). It will be investigated to understand the better and long-term survival, drug-resistant mechanism and hematology in occurrence of pneumonitis.
Time Frame
Pre-dose(within 6 week of completion of CCRT), after 8-week dosing, and confirmed disease progression (approximately 15 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sung Yong Lee
Phone
82 2 2626 1914
Email
syl0801@korea.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Youngsun Cho
Phone
82 70 4820 0249
Email
choyoungsun@procuratio.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung Yong Lee, MD, PhD
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kosin University Gospel Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jang
Phone
82 51 990 6637
First Name & Middle Initial & Last Name & Degree
Tae Won Jang, MD, PhD
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Park
Phone
82 53 258 4519
First Name & Middle Initial & Last Name & Degree
Sun Hyo Park, MD, PhD
Facility Name
Kyungpook National University Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shin Yup Lee, MD, PhD
Phone
82 53 200 3091
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee
Phone
82 42 280 6135
First Name & Middle Initial & Last Name & Degree
Jeong Eun Lee, MD, PhD
Facility Name
Chonnam National University Hospital Hwasun Hospital
City
Gwangju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oh
Phone
82 61 379 7869
First Name & Middle Initial & Last Name & Degree
In-Jae Oh, MD, PhD
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lim
Phone
82 32 890 3894
First Name & Middle Initial & Last Name & Degree
Jun Hyeok Lim, MD, MS
Facility Name
Pusan National University Yangsan Hospital
City
Pusan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seong Hoon Yoon, MD, PhD
Phone
82 55 360 1415
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Choi
Phone
82 2 3010 8358
First Name & Middle Initial & Last Name & Degree
Chang-Min Choi, MD, PhD
Facility Name
Hanyang University Seoul Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Park
Phone
82 2 2290 9065
First Name & Middle Initial & Last Name & Degree
Dong Won Park, MD, PhD
Facility Name
Koera University Guro Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee
Phone
82 2 2626 1914
First Name & Middle Initial & Last Name & Degree
Sung Yong Lee, MD, PhD
First Name & Middle Initial & Last Name & Degree
Juwhan Choi, MD, PhD
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Su In Choi, MD, PhD
Phone
82 2 920 5439
Facility Name
Kyung Hee University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee
Phone
82 2 958 8511
First Name & Middle Initial & Last Name & Degree
Seung Hyeun Lee, MD, PhD
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim
Phone
82 2228 2268
First Name & Middle Initial & Last Name & Degree
Eunyoung Kim, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36259253
Citation
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.
Results Reference
background

Learn more about this trial

A Study of Lazertinib as Consolidation Therapy in Patients With Locally Advanced, Unresectable, EGFR-Mutant Non-Small Cell Lung Cancer (Stage III) Following Chemoradiation Therapy

We'll reach out to this number within 24 hrs