Lazertinib for NSCLC Harboring Activating EGFR Mutations in TKI naïve Patients

NCT05463224 | Active Not Recruiting Phase 2

• 1 other identifier: 2022-09-029
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to evaluate the efficacy/safety of lazertinib and to explore the resistance mechanism of lazertinib as first-line in patients with NSCLC harboring activating EGFR mutations.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (2)

• progression-free survival

  C1D1 until the date of objective disease progression or death

  through study completion, an average of 18.0 month

• Resistance mechanism analysis

  The mutation profile of baseline and at the timepoint of resistance will be evaluated using tissue and cfDNA

  Screening, Discontiunuation Visit

Secondary Outcomes (7)

• Objective response rate (ORR)

  through study completion, an average of 18.0 month

• Duration of Response (DoR)

  through study completion, an average of 18.0 month

• Disease control rate (DCR)

  through study completion, an average of 18.0 month

• Overall survival (OS)

  through study completion, an average of 18.0 month

• intracranial PFS (iPFS)

  through study completion, an average of 18.0 month

Study Arms (1)

Lazertinib group

EXPERIMENTAL

Lazertinib 240mg daily (1 cycle of 21 days)

Drug: Lazertinib group

Interventions

Lazertinib group DRUG

Lazertinib 240mg, Once, po, daily (1 cycle of 21 days)

Also known as: Leclaza

Lazertinib group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer which is not amenable to treatment with a curative aim (e.g. surgery or radiation). Patients who underwent curative intent surgery or definitive CRT and experience recurrence after 6 months are eligible.
• Stage IIIC or IV by AJCC 8th edition
• Confirmed EGFR mutations (exon 19 deletion, L858R)(The result from both cell-free DNA or tissue-based DNA from the local test is allowed.)
• Age of 19 or more.
• Performance status of Eastern Cooperative Oncology Group 0 to 2.
• Expected minimum life expectancy of 12 weeks
• Adequate organ function.
• Available to provide the adequate tissue and blood for the genomic tests- At least 15 unstained slide and 20 cc of blood at baseline (mandatory) and disease progression.
• Agreed to perform re-biopsy at the timepoint of disease progression.
• At least two weeks after the chemotherapy
• Female subjects must either be of non-reproductive potential
• Subject willing and able to comply with the protocol
• Signed written informed consent

You may not qualify if:

• Previously treatment with any kind of EGFR TKI (Previously chemotherapy treated patients is allowed)
• Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug. (allowed for participation if investigator decided that previous malignancy is cured and not need for any additional treatment)
• Uncontrolled central nervous system metastases- patient with asymptomatic brain metastases or CNS symptom manageable with TKI and evaluated by investigator can be enrolled.
• Spinal cord compression, leptomeningeal carcinomatosis
• Uncontrolled systemic illness, including uncontrolled hypertension, active bleeding, or active infection
• Radiotherapy with a wide field of radiation within 2 weeks or radiotherapy with a limited field of radiation (localized radiotherapy or gamma knife surgery) for palliation within 1 week
• Any unresolved toxicities from prior therapy, greater than CTCAE grade 1
• Mean QT interval corrected for heart rate (QTc) ≥ 470 ms
• No measurable lesion
• Unable to swallow the product due to refractory nausea, vomiting or chornic gastrointestinal disease.

Sponsors & Collaborators

• Se-Hoon Lee: lead

Study Sites (1)

Samsung Medical Center

Seoul, Gangnamgu, 06351, South Korea

Location

MeSH Terms

Interventions

lazertinib

Study Officials

• Se-Hoon Lee, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D, Ph.D. Principal Investigator, Clinical Professor

Model Details: A single-arm, phase II single-center trial

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 18, 2022
• Study Start: January 4, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)