Clinical trial · Observational
Impact of Lazertinib Dose Modification on Effectiveness and Safety
Impact of Lazertinib Dose Modification on Effectiveness and Safety in EGFR T790M-Positive Advanced Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. 1. To evaluate Progression-free survival (PFS) of the group maintaining the same dose (240mg group) and the group in which dose reduction was performed (160mg group) for 12 weeks after the first administration of Lazertinib 2. In the group maintaining the same dose (240mg group) and the group in which dose reduction was performed (160mg group) for 12 weeks after the first administration of Lazertinib, Time-to-Treatment Discontinuation(TTD), Objective Response Rate(ORR), Disease Control Rate(DCR), Tumor shrinkage and Overall Survival(OS) is evaluated. 3. In the group maintaining the same dose (240mg group) and the group in which dose reduction was performed (160mg group) for 12 weeks after the first administration of Lazertinib, specific reasons (adverse event name, grade, etc.) according to Lazertinib dose adjustment is evaluated. 4. To evaluate the treatment profile of Lazertinib including duration of treatment, dose adjustment, and reason for discontinuation of treatment. 5. To evaluate the safety of Lazertinib in the 240 mg and 160 mg groups
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lazertinib | Drug | Lazertinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- 240mg group
- description
- Maintenance of the 240mg dose for 12 weeks after the first administration of Lazertinib
- interventionNames
- Drug: Lazertinib
- label
- 160mg group
- description
- Reduction of the 160mg dose for 12 weeks after the first administration of Lazertinib
- interventionNames
- Drug: Lazertinib
Primary outcomes (1)
- measure
- Progression Free Survival(PFS)
- timeFrame
- Up to approximately 3 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who agreed in writing to participate in this study 2. Adult men and women over 20 years of age 3. Patients with locally advanced or metastatic, recurrent non-small cell lung cancer with EGFR mutation (based on AJCC 8th edition) 4. Patients with confirmed disease progression after 1st or 2nd generation EGFR-TKI treatment 5. Patients scheduled to receive Lazertinib after T790M mutation was confirmed positive in tissue or plasma Exclusion Criteria: 1. Patients who are receiving or have already completed Lazertinib 2. Patients whose life expectancy is less than 12 weeks
References
Publications (0)
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