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| ID | Type | Description | Link |
|---|---|---|---|
| LASER IIT-018 | Other Grant/Funding Number | Yuhan Corporation |
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| Name | Class |
|---|---|
| Yuhan Corporation | INDUSTRY |
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The primary objective is to evaluate Progression Free Survival (PFS) of the group (160 mg group) in which dose reduction was performed for 12 weeks after the first administration of Lazertinib.
The Secondary objectives of this study are as follows.
This study is a prospective multi-center observational study, and 11 institutions will participate to enroll 200 subjects competitively. We will evaluate the efficacy and safety of Lazertinib according to maintenance of the 240mg dose and reduction of the 160mg dose for 12 weeks after the first administration of Lazertinib in non-small cell lung cancer patients confirmed to be T790M mutation-positive after treatment failure with first- or second-generation EGFR-TKIs. The study period is up to 3 years from the date of IRB approval. Follow-up is 2 years from the last subject enrollment, and data will be collected through periodic medical record review during Lazertinib administration for enrolled subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 240mg group | Maintenance of the 240mg dose for 12 weeks after the first administration of Lazertinib |
| |
| 160mg group | Reduction of the 160mg dose for 12 weeks after the first administration of Lazertinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lazertinib | Drug | Lazertinib 240mg(3tablets, 80mg/1tablet), once a day(QD), oral(PO), until disease progression or unacceptable toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival(PFS) | Progression-free survival is defined as the period from the start of Lazertinib administration to the time when objective disease progression is confirmed or death from any cause during treatment, whichever occurs first. | Up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time-to-Treatment Discontinuation (TTD) | Time-to-Treatment Discontinuation (TTD) is defined as the time from the start of Lazertinib administration to the point at which Lazertinib administration was discontinued for any reason. | Up to approximately 3 years |
| Objective Response Rate(ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who agreed to participate in this study among patients scheduled to receive Lazertinib after T790M mutation was confirmed positive after treatment with 1st or 2nd generation EGFR-TKIs
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Ki Lee, MD, PhD | Contact | +82-51-240-7216 | leemk@pusan.ac.kr | |
| Jung Seop Eom, MD, PhD | Contact | +82-51-240-7889 | ejspulm@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Min Ki Lee, MD, PhD | Pusan National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Busan Paik Hospital | Busan | 47392 | South Korea |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000707992 | lazertinib |
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Objective Response Rate (ORR) is defined as the proportion of subjects whose best overall response was complete response(CR) or partial response(PR) during the period of Lazertinib administration. |
| Up to approximately 3 years |
| Disease Control Rate (DCR) | Disease Control Rate (DCR) is defined as the proportion of subjects whose best overall response was complete response(CR), partial response(PR), or stable disease(SD) during the period of Lazertinib administration. | Up to approximately 3 years |
| Tumor shrinkage | Tumor shrinkage is defined as the ratio of the size of the primary lesion at the time of baseline before the first administration of Lazertinib and the size of the primary lesion at the time of maximum overall response during Lazertinib administration. | Up to approximately 3 years |
| Overall Survival (OS) | Overall Survival (OS) is defined as the period from the start of Lazertinib administration to death from any cause. | Up to approximately 3 years |
| Inje University Haeundae Paik Hospital | Busan | 48108 | South Korea |
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| Dong-A University Hospital | Busan | 49201 | South Korea |
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| Pusan National University Hospital | Busan | 49241 | South Korea |
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| Kosin University Gospel Hospital | Busan | 49267 | South Korea |
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| Kyungpook National University Chilgok Hospital | Daegu | 41404 | South Korea |
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| Kyungpook National University Hospital | Daegu | 41944 | South Korea |
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| Yeungnam University Medical Center | Daegu | 42415 | South Korea |
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| Daegu Catholic University Medical Center | Daegu | 42472 | South Korea |
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| Keimyung University Dongsan Medical Center | Daegu | 42601 | South Korea |
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| Pusan National University Yangsan Hospital | Yangsan | 50612 | South Korea |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |