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