Lazertinib 160mg in EGFR T790M NSCLC

Samsung Medical Center

Status and phase: Not yet enrolling; Phase 2

Conditions: Lung Cancer Stage IV; EGFR T790M

Treatments: Drug: Lazertinib

Study type: Interventional

Funder types: Other

Identifiers

NCT05701384

SMC 2023-01-17

Details and patient eligibility

About

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.

Enrollment: 117 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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117 participants in 1 patient group

Lazertinib 160mg arm

Experimental group

Treatment:

Drug: Lazertinib