None listed
Conditions
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To participate in this program, the patient must meet all of the following criteria. 1) As a patient who participated in the Razertinib clinical trial and was receiving Razertinib treatment, he completed the Razertinib clinical trial and continued in this program a person who has consented to treatment 2) If the tester determines that the benefit of continuing the treatment with laser-tinib will exceed the risk 3) For female patients, they can participate if they are not lactating and fall under at least one of the following conditions: - Not the WOCBP defined in Appendix 1 Or - WOCBP, which agreed to follow the contraceptive guidelines in Appendix 1 (including the prohibition of ovary/ oocyte donation) from the time of written consent to 3 months after the last administration of lasertinib, and in this case, a human chorionic gonadotropin [ß-hCG] serum test or pregnancy urine test prior to the first administration of lasertinib should be negative. 4) For male patients who did not undergo vasectomy, the contraceptive guidelines in Appendix 1 should be followed up to 3 months after discontinuation of laser tinib administration, and it should be agreed that sperm donation is prohibited during this period. 5) The patient must sign a written consent form indicating that he/she understands the purpose and procedure of this program and intends to participate in the program.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following exclusion criteria are not eligible for this program 1) Patients who are currently receiving or need treatment with prohibited drugs according to permission 2) If, in the tester's view, the patient is at significant risk, or if the program determines that there are any conditions or circumstances that could seriously interfere with the subject's continued laser-tinib administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This program is designed to provide continuous laser tinib to completed laser tinib clinical trial subjects. There is no formal hypothesis planned for this program. | — |
Countries
Korea, Republic of
Contacts
Public ContactJIN HYOUNG KANG
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed