Ignite Creation Date:
2024-07-17 @ 10:53 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486142
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-05-07
Brief Title:
EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study
Sponsor:
Region Skane
Organization:
Region Skane
Study Overview
Official Title:
EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ERIS
Brief Summary:
The purpose of this study is to evaluate the optimal sequence of EGFR-inhibitors in lung cancer patients with EGFR-positive tumors not amenable for curative treatment Life quality adverse effects and tumor response will be evaluated and analyses of obtained blood and tumor samples will be performed to identify molecular profiles and biomarkers that can be used for treatment decisions
Detailed Description:
ERIS is an investigator-initiated randomized phase III trial Non-small cell lung cancer NSCLC patients with advanced disease not amenable for curative treatment are considered for targeted therapy For first-line treatment in patients with EGFR-positive tumors there are now several options of which osimertinib a third generation EGFR-TKI and dacomitinibafatinib second generation EGFR-TKIs are considered first-hand choices Dacomitinibafatinib treatment might be switched to osimertinib in the event of treatment failure provided that an EGFR T790M mutation is detected However in about half of patients with second generation EGFR- TKI treatment failure the resistance mechanism is different from T790M Thus there is a need to identify which patients that benefit from osimertinib in first line and which patients that rather benefit from a second-generation EGFR-TKI in first line respectively Early treatment prediction and monitoring through biomarkers in blood and tumor could be one step forward in individualized treatment
After being informed about the study patients with EGFR-positive NSCLC considered for first-line treatment will sign a consent and undergo a screening period to determine eligibility for study entry When screening is completed and inclusion criteria are met study participants will be randomized in a 11 ratio to osimertinib or afatinibdacomitinib
Patients randomized to afatinibdacomitinib will be able to cross-over to osimertinib in the event of progression and confirmed T790M-mutation In the event of progression on osimertinib or on afatinibdacomitinib without T790M the study participants will be treated as chosen by the investigator and in accordance with applicable national guidelines
Longitudinal blood samples and when appropriate tumor tissuecytology or other fluids pleural effusion etc will be assembled and used for comprehensive analysis to study potential biomarkers
After being informed about the study patients with EGFR-positive NSCLC considered for first-line treatment will sign a consent and undergo a screening period to determine eligibility for study entry When screening is completed and inclusion criteria are met study participants will be randomized in a 11 ratio to osimertinib or afatinibdacomitinib
Patients randomized to afatinibdacomitinib will be able to cross-over to osimertinib in the event of progression and confirmed T790M-mutation In the event of progression on osimertinib or on afatinibdacomitinib without T790M the study participants will be treated as chosen by the investigator and in accordance with applicable national guidelines
Longitudinal blood samples and when appropriate tumor tissuecytology or other fluids pleural effusion etc will be assembled and used for comprehensive analysis to study potential biomarkers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None