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Clinical Trials/NCT05701384
NCT05701384Not yet recruitingPhase 2

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

Samsung Medical Center1 site in 1 country117 target enrollmentStarted: February 1, 2023Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Enrollment
117
Locations
1
Primary Endpoint
The dose reduction or treatment discontinuation rate

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Lazertinib 160mg arm

Experimental

Intervention: Lazertinib (Drug)

Outcomes

Primary Outcomes

The dose reduction or treatment discontinuation rate

Time Frame: Total 24 months of study period

Dose who received dosage below 160mg or discontinued due to the adverse event

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jong-Mu Sun

Professor

Samsung Medical Center

Study Sites (1)

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