Impact of Concomitant Genetic Alterations in EGFR Mutated Adenocarcinoma by NGS Analysis: A Multicenter Study

August 16, 2022 updated by: Kye Young Lee, Konkuk University Medical Center

A Next-generation Sequencing Analysis to Investigate the Clinical Impact of Concomitant Genetic Alterations in the Patients With Advanced EGFR-mutated Lung Adenocarcinoma: A Multicenter Study.

The concomitant co-mutation with epidermal growth factor receptor (EGFR) mutation might influence the clinical outcomes. The investigators will identify the impact of concommitant mutation on clinical outcome in patients with advanced -EGFR mutated adenocarcinoma.

The investigators will compare the genetic alterations between tumors of pre and post Tyrosin Kinase Inhibitor(TKI) treatments and predict the resistance mechanism for EGFR-TKIs by next-generation sequencing(NGS) analysis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The current standard therapies in the treatment of advanced EGFR-mutated lung cancer patients are the 1st or 2nd EGFR-TKIs. Although 70-80% of patients treated by EGFR-TKIS show good responses, they have progression after around 12 months. The concomitant co-mutation with EGFR mutation might influence the drug response of EGFR TKI. The investigators will compare the progression-free survival (PFS) of EGFR-TKI according to co-occuring mutations.

The patients experience the change of molecular profiles after using the TKI. Therefore, the investigators will investigate the molecular profiles through NGS panel with foundation medicine in the tissue of pre/post EGFR-TKI, compare the change of the molecular profiles and tumor mutation burden(TMB), and identify novel mechanisms of drug resistance.

The investigators will collect the tumor tissues and blood of around 80 patients in multi-centers prospectively. Then, They will be sent to FoundationOne in the US and perform NGS analysis. The type of EGFR-TKIs would be selected according to physicians' preference. NGS will be performed twice before the EGFR-TKIs treatment and after the progression.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center
        • Contact:
          • Jae Chul Lee, Ph.D
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Catholic university medical center, Seoul St. Mary's Hospital
        • Contact:
          • Seung Joon Kim, MD.Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

EGFR-mutated stage IV lung adenocarcinoma patients

Description

Inclusion Criteria:

  1. Signed Informed Consent Form
  2. Age ≥19 years
  3. EGFR-mutated stage IV lung adenocarcinoma patients
  4. Archival biopsy tissues which are from core needle biopsies, endobronchial ultrasound (EBUS) guided- lymph node biopsy or lymph node excisional biopsy at baseline and at radiologic progression
  5. Availability of the 10 unstained slides and 1 H&E slides at pre/ post TKI treatment
  6. Samples should contain a minimum of 20% viable tumor cells that preserve

Exclusion Criteria:

Tumor tissue from bone metastases that have been decalcified are not acceptable.

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of mutation profiles between pre/post TKI treatment
Time Frame: through study completion, an average of 1 year
Comparison of the kinds of the mutation between pre- and post TKI treatment
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS according to the co-occurring mutations with pre-TKI treatment
Time Frame: through study completion, an average of 1 year
The investigators will compared the PFS according to the kinds of co-occuring genetic alteration in patient with EGFR -mutated adenocarcinoma before the EGFR TKI treatment
through study completion, an average of 1 year
The number and the kinds of co-occurring mutations on tumors before and after TKI treatment
Time Frame: through study completion, an average of 1 year
The investigators will collect the information about the number and the kinds of co-occurring mutations on tumors before and after TKI treatment in Foundation medicine NGS
through study completion, an average of 1 year
The correlation between the change of variant allele frequency(VAF) and drug response in matched tumors tissues before and after TKI treatment
Time Frame: through study completion, an average of 1 year
The investigators will analyze the correlation with the change of the VAF and PFS in matched tumors tissues before and after TKI treatment
through study completion, an average of 1 year
Tumor mutation burden in tumors tissues before and after TKI treatment
Time Frame: through study completion, an average of 1 year
The investigators will compare the TMB in tumors tissues before and after TKI
through study completion, an average of 1 year
The concordance the the mutation profiles in the NGS results of tissue and blood in the same patients
Time Frame: through study completion, an average of 1 year
The investigators will compare the concordance of the mutation profile in tumors and blood before TKI treatment
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konkuk University Medical Center

Collaborators

Foundation Medicine
Roche Diagnostics

Investigators

  • Study Director: In Ae Kim, MD. Ph.D, Kunkuk University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2019

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

October 3, 2019

First Submitted That Met QC Criteria

October 9, 2019

First Posted (Actual)

October 10, 2019

Study Record Updates

Last Update Posted (Actual)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML41560

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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