search
Back to results

Feasibility of Intratumoral Washing Fluid for Detecting EGFR Mutations in Lung Cancer

Primary Purpose

Non Small Cell Lung Cancer, EGFR Gene Mutation

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ultarthin bronchoscopy with intratumoral washing
Sponsored by
Pusan National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non Small Cell Lung Cancer focused on measuring Carcinoma, Non-Small-Cell Lung, EGFR Genes, Bronchoscopy, Liquid biopsy, T790M

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥ 20 years
  • Obtained written informed consent
  • Patients diagnosed with NSCLC by histology or cytology and inoperable stage IV at the time of study enrollment
  • Patients with the following EGFR gene mutations: E19Del, L858R alone or concurrent rare EGFR gene mutations (T790M, G719X, exon 20 insertion, S768I)
  • Patients previously treated with EGFR-TKIs such as gefitinib, erlotinib, afatinib, dacomitinib as first line therapy
  • Patients who had shown clinical benefits (CR, PR, SD) from EGFR-TKIs and had been confirmed PD on those therapy according to RECIST v 1.1.
  • Patients who underwent liquid biopsy (plasma) for EGFR mutation at the time of PD on EGFR-TKIs
  • Patients who plan to undergo tissue biopsy for EGFR mutation at the time of PD on EGFR-TKIs

Exclusion Criteria:

  • Patients who withdraw informed consent
  • Patients who are unable to undergo liquid biopsy (plasma) and tissue biopsy for EGFR mutation based on the investigator's judgement

Sites / Locations

  • Pusan National University hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ultrathin bronchoscopy with intratumoral washing

Arm Description

Each subject with NSCLC will undergo bronchooscopic procedure for EGFR mutation (including T790M positivity) evaluation.

Outcomes

Primary Outcome Measures

The DNA and EGFR mutation (including T790M positivity) detection rate in intratumoral washing fluid
Defined as the number of DNA and EGFR mutation (including T790M positivity) detection divided by the total attempts of intratumoral washing by ultrathin bronchoscopy.

Secondary Outcome Measures

The concordance rate of EGFR mutation (including T790M positivity) detection rate among intratumoral washing fluid, plasma, and tissue
The concordance rate of EGFR mutation (including T790M positivity) detection rate in intratumoral washing fluid, compared with plasma and tissue (gold standard).
The EGFR mutation (including T790M positivity) sensitivity and specificity in intratumoral washing fluid
The sensitivity and specificity of EGFR mutation (including T790M positivity) in intratumoral washing fluid compared with tissue (gold standard).
Objective response rate
Objective response rate (ORR) including rate of complete response (CR) and partial response (PR) based on RECIST 1.1.
Disease control rate
Disease control rate (DCR) including rate of CR, PR and stable disease (SD) based on RECIST 1.1.
Progression-free survival
Progression-free survival (PFS) the time from first dose of the study drug until the date of progressive disease (PD) based on RECIST 1.1 or death by any cause.

Full Information

First Posted
July 30, 2022
Last Updated
October 16, 2023
Sponsor
Pusan National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05517083
Brief Title
Feasibility of Intratumoral Washing Fluid for Detecting EGFR Mutations in Lung Cancer
Official Title
Feasibility of Intratumoral Washing Fluid for Detecting EGFR Mutations in Advanced Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pusan National University Hospital

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to evaluate the relevance of intratumoral washing for detection of EGFR mutation (including T790M positivity).
Detailed Description
This is a prospective, single-arm, open-label study to assess evaluate the relevance of intratumoral washing by ultrathin bronchoscopy (outer diameter; 3mm) for detection of EGFR mutation (including T790M positivity) using cobas real-time PCR and droplet digital PCR (DDPCR) in patients with NSCLC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer, EGFR Gene Mutation
Keywords
Carcinoma, Non-Small-Cell Lung, EGFR Genes, Bronchoscopy, Liquid biopsy, T790M

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrathin bronchoscopy with intratumoral washing
Arm Type
Experimental
Arm Description
Each subject with NSCLC will undergo bronchooscopic procedure for EGFR mutation (including T790M positivity) evaluation.
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultarthin bronchoscopy with intratumoral washing
Intervention Description
Each subject with NSCLC will undergo bronchooscopic procedure. First, ultrathin bronchoscope is inserted and placed within tumor under radial EBUS, virtual bronchoscopic navigation, and fluoroscopy guidance. Then, intratumoral washing is performed. Subsequently, transbronchial lung biopsy is performed under radial EBUS, virtual bronchoscopic navigation, and fluoroscopy guidance.
Primary Outcome Measure Information:
Title
The DNA and EGFR mutation (including T790M positivity) detection rate in intratumoral washing fluid
Description
Defined as the number of DNA and EGFR mutation (including T790M positivity) detection divided by the total attempts of intratumoral washing by ultrathin bronchoscopy.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
The concordance rate of EGFR mutation (including T790M positivity) detection rate among intratumoral washing fluid, plasma, and tissue
Description
The concordance rate of EGFR mutation (including T790M positivity) detection rate in intratumoral washing fluid, compared with plasma and tissue (gold standard).
Time Frame
through study completion, an average of 1 year
Title
The EGFR mutation (including T790M positivity) sensitivity and specificity in intratumoral washing fluid
Description
The sensitivity and specificity of EGFR mutation (including T790M positivity) in intratumoral washing fluid compared with tissue (gold standard).
Time Frame
through study completion, an average of 1 year
Title
Objective response rate
Description
Objective response rate (ORR) including rate of complete response (CR) and partial response (PR) based on RECIST 1.1.
Time Frame
through study completion, an average of 1 year
Title
Disease control rate
Description
Disease control rate (DCR) including rate of CR, PR and stable disease (SD) based on RECIST 1.1.
Time Frame
through study completion, an average of 1 year
Title
Progression-free survival
Description
Progression-free survival (PFS) the time from first dose of the study drug until the date of progressive disease (PD) based on RECIST 1.1 or death by any cause.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 20 years Obtained written informed consent Patients diagnosed with NSCLC by histology or cytology and inoperable stage IV at the time of study enrollment Patients with the following EGFR gene mutations: E19Del, L858R alone or concurrent rare EGFR gene mutations (T790M, G719X, exon 20 insertion, S768I) Patients previously treated with EGFR-TKIs such as gefitinib, erlotinib, afatinib, dacomitinib as first line therapy Patients who had shown clinical benefits (CR, PR, SD) from EGFR-TKIs and had been confirmed PD on those therapy according to RECIST v 1.1. Patients who underwent liquid biopsy (plasma) for EGFR mutation at the time of PD on EGFR-TKIs Patients who plan to undergo tissue biopsy for EGFR mutation at the time of PD on EGFR-TKIs Exclusion Criteria: Patients who withdraw informed consent Patients who are unable to undergo liquid biopsy (plasma) and tissue biopsy for EGFR mutation based on the investigator's judgement
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mi-Hyun Kim, MD, PhD
Phone
82 51 240 7889
Email
mihyunkim@pusan.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Soo Han Kim, MD, PhD
Phone
82-51-240-7889
Email
kshyjt1004@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mi-Hyun Kim, PhD
Organizational Affiliation
Pusan National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mi-Hyun Kim, MD, PhD
Phone
82 51 240 7889
Email
mihyunkim@pusan.ac.kr
First Name & Middle Initial & Last Name & Degree
Soo Han Kim, MD, PhD
Phone
82 51 240 7889
Email
kshyjt1004@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Feasibility of Intratumoral Washing Fluid for Detecting EGFR Mutations in Lung Cancer

We'll reach out to this number within 24 hrs