2024 World Conference on Lung Cancer (WCLC) - Posters-P2.10A.07 Trofuse-009: Phase 3 Study of Sac-TMT vs Platinum-Doublet Chemotherapy for Previously Treated EGFR-Mutated Advanced NSCLC

P2.10A.07 Trofuse-009: Phase 3 Study of Sac-TMT vs Platinum-Doublet Chemotherapy for Previously Treated EGFR-Mutated Advanced NSCLC

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Pdf Summary

The TroFuse-009 study is a Phase 3 clinical trial comparing sacituzumab tirumotecan (sac-TMT) against platinum-doublet chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC) possessing certain epidermal growth factor receptor (EGFR) mutations and who have shown disease progression post-EGFR tyrosine kinase inhibitor (TKI) therapy. Sac-TMT is an antibody-drug conjugate targeting the TROP2 antigen, which is associated with tumor growth and invasion. This study aims to provide evidence on the efficacy and safety of sac-TMT, leveraging its promising antitumor activity and manageable toxicity reported in earlier phase studies.<br /><br />Key study objectives are to evaluate progression-free survival (PFS) and overall survival (OS) as primary endpoints, along with secondary outcomes including overall response rate (ORR), duration of response (DOR), and assessing patient safety and quality of life through patient-reported outcomes (PROs). The study aims to enroll 520 patients, who are randomized into two arms: one receiving sac-TMT and the other undergoing standard chemotherapy. <br /><br />In order to participate, patients must have advanced or metastatic NSCLC with specific EGFR mutations and prior EGFR TKI treatment without brain metastases requiring recent corticosteroids use. Exclusions include individuals with squamous cell histology, significant peripheral neuropathy, previous TROP2 or topoisomerase I-targeted therapies, and active CNS metastases or interstitial lung disease.<br /><br />This study, currently enrolling, was initiated on June 11, 2024, and spans 36 international sites. The trial's progression will be monitored via tumor imaging and patient assessments, with statistical analyses focused on efficacy and safety outcomes. The trial is sponsored by Merck & Co., with contact details of Dr. Natasha B. Leighl provided for further inquiries.

Asset Subtitle

Natasha Leighl

Meta Tag

Speaker Natasha Leighl

Topic Metastatic NSCLC – Cytotoxic Therapy

Keywords

TroFuse-009

sacituzumab tirumotecan

NSCLC

EGFR mutations

antibody-drug conjugate

progression-free survival

overall survival

patient-reported outcomes

Merck & Co.

clinical trial