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

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Brief Title

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

Official Title

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.

Brief Summary

      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.
    

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


Primary Outcome

Change of mutation profiles between pre/post TKI treatment

Secondary Outcome

 PFS according to the co-occurring mutations with pre-TKI treatment

Condition

Adenocarcinoma of Lung

Intervention

Next generation sequencing


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

80

Start Date

September 30, 2019

Completion Date

December 31, 2021

Primary Completion Date

September 30, 2020

Eligibility Criteria

        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.

        -
      

Gender

All

Ages

19 Years - N/A


Contacts

In Ae Kim, MD. Ph.D, 01035438353, [email protected]

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT04122833

Organization ID

ML41560


Responsible Party

Principal Investigator

Study Sponsor

Konkuk University Medical Center

Collaborators

 Roche Diagnostics

Study Sponsor

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


Verification Date

October 2019