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

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ClinicalTrials.gov Identifier: NCT04122833
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Collaborators:
Roche Diagnostics
Foundation Medicine
Information provided by (Responsible Party):
Kye Young Lee, Konkuk University Medical Center

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.


Condition or disease Intervention/treatment
Adenocarcinoma of Lung EGFR Activating Mutation Other: Next generation sequencing

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.


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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
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.
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Next generation sequencing
    observational study


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
EGFR-mutated stage IV lung adenocarcinoma patients
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.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122833


Contacts
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Contact: In Ae Kim, MD. Ph.D 01035438353 20180618@kuh.ac.kr
Contact: Kye Young Lee, MD. Ph.D 01088963916 kykeemd@kuh.ac.kr

Locations
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Korea, Republic of
Asan medical center Recruiting
Seoul, Korea, Republic of, 05505
Contact: Jae Chul Lee, Ph.D         
Catholic university medical center, Seoul St. Mary's Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Seung Joon Kim, MD.Ph.D.         
Sponsors and Collaborators
Konkuk University Medical Center
Roche Diagnostics
Foundation Medicine
Investigators
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Study Director: In Ae Kim, MD. Ph.D Kunkuk University Medical Center

Publications:

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Responsible Party: Kye Young Lee, Professor, Konkuk University Medical Center
ClinicalTrials.gov Identifier: NCT04122833     History of Changes
Other Study ID Numbers: ML41560
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kye Young Lee, Konkuk University Medical Center:
next generation sequencing
Additional relevant MeSH terms:
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Adenocarcinoma
Adenocarcinoma of Lung
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site