NCT06486142

EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 dacomitinib/afatinib (second generation EGFR-TKIs) are considered first-hand choices. Dacomitinib/afatinib 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 1:1 ratio to osimertinib or afatinib/dacomitinib. Patients randomized to afatinib/dacomitinib 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 afatinib/dacomitinib 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 tissue/cytology or other fluids (pleural effusion etc.) will be assembled and used for comprehensive analysis to study potential biomarkers.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Afatinib/Dacomitinib	Second-generation EGFR-inhibitors
DRUG	Osimertinib	Third-generation EGFR-inhibitor

Timeline

• Start date: 2022-09-21
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2024-07-03
• Last updated: 2024-07-03

Locations

1 site across 1 country: Sweden