Clinical trial · Interventional
Lazertinib 160mg in EGFR T790M NSCLC
A Phase II Study for the Evaluation of the Feasibility of Lazertinib 160mg Per Day in Patients With EGFR T790M Mutant Non-small Cell Lung Cancer
NCT05701384CI-TRIAL-00063497unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 lazertinib is currently approved as 2nd line T790M mutation-positive NSCLC that failed from either 1st or 2nd generation EGFR TKI. The current recommended dosage is 240mg. Based on the promising clinical efficacy of the dose escalation study, this study is designed to evaluatee the clinical efficacy and safety of 160mg lazertinib.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EGFR T790M | — | UNRESOLVED | — |
| Lung Cancer Stage IV | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lazertinib | Drug | Lazertinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lazertinib 160mg arm
- interventionNames
- Drug: Lazertinib
Primary outcomes (1)
- measure
- The dose reduction or treatment discontinuation rate
- timeFrame
- Total 24 months of study period
- description
- Dose who received dosage below 160mg or discontinued due to the adverse event
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed non-small cell lung cancer * Patients in a palliative setting who is not applicable for the curative treatment * EGFR mutation positive patients who received previous 1st or 2nd generation EGFR TKI * Confirmed EGFR T790M mutation after the previous EGFR TKI * Available to receive lazertinib either as po or vis levine tube * Willing to participate clinical trial * Age over or equal to 19 * ECOG PS 0 to 2 Exclusion Criteria: * Previously received 3rd generation EGFR TKI * No clinical benefit is expected based on the investigator's decision * Uncontrolled symptomatic CNS metastases * Uncontrolled systemic disease
References
Publications (0)
Data not yet available
No reference posted for this study.