PLATINUM: 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

Sponsor

Sung Yong Lee (Other)

Overall Status

Recruiting

CT.gov ID

NCT05338619

Collaborator

Yuhan Corporation (Industry)

Enrollment

Locations

Arm

44.1

Anticipated Duration (Months)

7.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer Stage III EGFR Positive Non-small Cell Lung Cancer Non-squamous Non-small-cell Lung Cancer	Drug: Lazertinib	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

77 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Lazertinib treatment group (open-label)Lazertinib treatment group (open-label)

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Jun 30, 2022

Anticipated Primary Completion Date :

Mar 2, 2026

Anticipated Study Completion Date :

Mar 2, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lazertinib Lazertinib 240mg, oral, QD	Drug: Lazertinib 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. Other Names: LECLAZA

Arm

Intervention/Treatment

Experimental: Lazertinib

Lazertinib 240mg, oral, QD

Drug: Lazertinib

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.

Other Names:

LECLAZA

Outcome Measures

Primary Outcome Measures

Progression free survival (PFS) [Tumor scan will be performed at baseline the every 8 weeks until confirmed disease progression (up to 4 years)]
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) [Until death (up to maximum of approximately 4 years)]
The time from the date of enrollment until the date of death
Objective response rate (ORR) [Tumor scan will be performed at baseline the every 8 weeks until confirmed disease progression (up to 4 years)]
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) [Tumor scan will be performed at baseline the every 8 weeks until confirmed disease progression (up to 4 years)]
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) [Until death or distant metastasis (up to maximum of approximately 4 years)]
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 [every visit (up to maximum of approximately 4 years)]
Adverse events, Serious adverse events or other significant safety findings

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	Kosin University Gospel Hospital	Busan	Korea, Republic of
2	Keimyung University Dongsan Hospital	Daegu	Korea, Republic of
3	Chungnam National University Hospital	Daejeon	Korea, Republic of
4	Chonnam National University Hospital Hwasun Hospital	Gwangju	Korea, Republic of
5	Asan Medical Center	Seoul	Korea, Republic of
6	Hanyang University Seoul Hospital	Seoul	Korea, Republic of
7	Koera University Guro Hospital	Seoul	Korea, Republic of
8	Konkuk University Medical Center	Seoul	Korea, Republic of
9	Kyung Hee University Hospital	Seoul	Korea, Republic of
10	Yonsei University Health System, Severance Hospital	Seoul	Korea, Republic of