Impact of Concomitant Genetic Alterations in EGFR Mutated Adenocarcinoma by NGS Analysis: A Multicenter Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04122833|
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
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|
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|
|Estimated Enrollment :||80 participants|
|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|
- Other: Next generation sequencing
- 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
- 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
- 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
- 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
- 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
- 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
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
|Contact: In Ae Kim, MD. Ph.Demail@example.com|
|Contact: Kye Young Lee, MD. Ph.Dfirstname.lastname@example.org|
|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.|
|Study Director:||In Ae Kim, MD. Ph.D||Kunkuk University Medical Center|