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| ID | Type | Description | Link |
|---|---|---|---|
| LASER IIT-010 | Other Grant/Funding Number | YUHAN Coorporation |
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| Name | Class |
|---|---|
| Yuhan Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lazertinib | Experimental | Lazertinib 240mg, oral, QD |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lazertinib | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | The time from the date of enrollment until the date of death | Until death (up to maximum of approximately 4 years) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes form baseline in different biomarkers | 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. | Pre-dose(within 6 week of completion of CCRT), after 8-week dosing, and confirmed disease progression (approximately 15 months) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sung Yong Lee | Contact | 82 2 2626 1914 | syl0801@korea.ac.kr | |
| Youngsun Cho | Contact | 82 70 4820 0249 | choyoungsun@procuratio.kr |
| Name | Affiliation | Role |
|---|---|---|
| Sung Yong Lee, MD, PhD | Korea University Guro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kosin University Gospel Hospital | Recruiting | Busan | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36259253 | Background | 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. | |
| 36268845 |
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Lazertinib treatment group (open-label)
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|
| 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) | 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. | 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) | 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. | Until death or distant metastasis (up to maximum of approximately 4 years) |
| Safety profile : Adverse Events according to CTCAE V5.0 | Adverse events, Serious adverse events or other significant safety findings | every visit (up to maximum of approximately 4 years) |
| Keimyung University Dongsan Hospital | Recruiting | Daegu | South Korea |
|
| Kyungpook National University Medical Center | Recruiting | Daegu | South Korea |
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| Chungnam National University Hospital | Recruiting | Daejeon | South Korea |
|
| Chonnam National University Hospital Hwasun Hospital | Recruiting | Gwangju | South Korea |
|
| Inha University Hospital | Recruiting | Incheon | South Korea |
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| Pusan National University Yangsan Hospital | Recruiting | Pusan | South Korea |
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| Asan Medical Center | Recruiting | Seoul | South Korea |
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| Hanyang University Seoul Hospital | Recruiting | Seoul | South Korea |
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| Koera University Guro Hospital | Recruiting | Seoul | South Korea |
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| Korea University Anam Hospital | Recruiting | Seoul | South Korea |
|
| Kyung Hee University Hospital | Recruiting | Seoul | South Korea |
|
| Yonsei University Health System, Severance Hospital | Recruiting | Seoul | South Korea |
|
| Derived |
| 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. |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000707992 | lazertinib |
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