An observational study in Non-small Cell Lung Cancer, sponsored by Pusan National University Hospital. Not yet recruiting at 11 sites in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Pusan National University Hospital · Observational
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.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 200 is above the median of 160 across 1,148 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Pusan National University Hospital is the lead sponsor of 80 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Maintenance of the 240mg dose for 12 weeks after the first administration of Lazertinib
Drug: Lazertinib
Reduction of the 160mg dose for 12 weeks after the first administration of Lazertinib
Drug: Lazertinib
Lazertinib 240mg(3tablets, 80mg/1tablet), once a day(QD), oral(PO), until disease progression or unacceptable toxicity
Also known as: LECLAZA
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.
Time frame: Up to approximately 3 years
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.
Time frame: Up to approximately 3 years
Objective Response Rate(ORR)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 3 years
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2023; primary completion for Dec 2025, 34 months later.
Of 355 non-industry observational studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 126. This study's planned 34 months is below that.
Counting every sponsor, half of 497 studies reached it within 55 months; a quarter within 35 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung →
Pusan National University Hospital