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Lazertinib for NSCLC Harboring Activating EGFR Mutations in TKI naïve Patients

Primary Purpose

NSCLC

Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lazertinib group
Sponsored by
Myung-Ju Ahn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NSCLC

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lazertinib group

Arm Description

Lazertinib 240mg daily (1 cycle of 21 days)

Outcomes

Primary Outcome Measures

progression-free survival
C1D1 until the date of objective disease progression or death
Resistance mechanism analysis
The mutation profile of baseline and at the timepoint of resistance will be evaluated using tissue and cfDNA

Secondary Outcome Measures

Objective response rate (ORR)
as the percentage of patients with measurable disease with at least one visit response of complete response (CR) or partial response (PR)
Duration of Response (DoR)
as the time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first
Disease control rate (DCR)
as the percentage of patients who have a best overall response of CR or PR or stable disease (SD at ≥ 6 weeks, prior to any PD event)
Overall survival (OS)
s the time from the date of C1D1 until the date of death due to any cause
intracranial PFS (iPFS)
as the time from C1D1 until the date of objective intracranial disease progression or death whichever comes first in patients for the iFAS
intracranial ORR (iORR)
as the percentage of patients who have at least 1 CR or PR in intracranial lesion, according to RECIST v1.1 prior to disease progression in patients who have at least one measurable intracranial lesion at baseline
intracranial DCR (iDCR)
as the percentage of patients who have a best intracranial overall response of CR or PR or SD in patients who have at least one measurable intracranial lesion at baseline

Full Information

First Posted
July 8, 2022
Last Updated
March 29, 2023
Sponsor
Myung-Ju Ahn
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1. Study Identification

Unique Protocol Identification Number
NCT05463224
Brief Title
Lazertinib for NSCLC Harboring Activating EGFR Mutations in TKI naïve Patients
Official Title
Lazertinib for NSCLC Harboring Activating EGFR Mutations in TKI naïve Patients: A Single-arm, Phase II Single-center Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2023 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Myung-Ju Ahn

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
As the 3rd generation EGFR TKI become a standard treatment option for the 1st line therapy in EGFR mutated patients, necessity for evaluating resistant mechanism to determine the matched subsequent therapeutic option has been highlighted. The idea of understanding the exact resistance mechanism to 1st line 3rd generation EGFR TKI treatment is emphasized based on the observation that resistance mechanism is different based on osimertinib used as 1st line or 2nd line treatment.6,7 Although resistance mechanisms to lazertinib in patients with prior EGFR TKI treatment have been studied, there are no current data available regarding the resistance mechanism after first-line lazertinib treatment. Based on this observation, PI designed this study to elucidate the efficacy/safety of Lazertinib and to explore resistance mechanisms of 1st line lazertinib treatment in NSCLC patients with activating EGFR mutation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
A single-arm, phase II single-center trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lazertinib group
Arm Type
Experimental
Arm Description
Lazertinib 240mg daily (1 cycle of 21 days)
Intervention Type
Drug
Intervention Name(s)
Lazertinib group
Intervention Description
Lazertinib 240mg, Once, po, daily (1 cycle of 21 days)
Primary Outcome Measure Information:
Title
progression-free survival
Description
C1D1 until the date of objective disease progression or death
Time Frame
through study completion, an average of 18.0 month
Title
Resistance mechanism analysis
Description
The mutation profile of baseline and at the timepoint of resistance will be evaluated using tissue and cfDNA
Time Frame
Screening, Discontiunuation Visit
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
as the percentage of patients with measurable disease with at least one visit response of complete response (CR) or partial response (PR)
Time Frame
through study completion, an average of 18.0 month
Title
Duration of Response (DoR)
Description
as the time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first
Time Frame
through study completion, an average of 18.0 month
Title
Disease control rate (DCR)
Description
as the percentage of patients who have a best overall response of CR or PR or stable disease (SD at ≥ 6 weeks, prior to any PD event)
Time Frame
through study completion, an average of 18.0 month
Title
Overall survival (OS)
Description
s the time from the date of C1D1 until the date of death due to any cause
Time Frame
through study completion, an average of 18.0 month
Title
intracranial PFS (iPFS)
Description
as the time from C1D1 until the date of objective intracranial disease progression or death whichever comes first in patients for the iFAS
Time Frame
through study completion, an average of 18.0 month
Title
intracranial ORR (iORR)
Description
as the percentage of patients who have at least 1 CR or PR in intracranial lesion, according to RECIST v1.1 prior to disease progression in patients who have at least one measurable intracranial lesion at baseline
Time Frame
through study completion, an average of 18.0 month
Title
intracranial DCR (iDCR)
Description
as the percentage of patients who have a best intracranial overall response of CR or PR or SD in patients who have at least one measurable intracranial lesion at baseline
Time Frame
through study completion, an average of 18.0 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Myung-Ju Ahn, MD
Phone
82-2-3410-3488
Email
silk.ahn@samsung.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gangnamgu
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myung-Ju Ahn

12. IPD Sharing Statement

Plan to Share IPD
No

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Lazertinib for NSCLC Harboring Activating EGFR Mutations in TKI naïve Patients

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