2024 World Conference on Lung Cancer (WCLC) - Posters-P2.10A.06 Phase 3 TroFuse-004 Study: Sac-TMT vs Chemotherapy for Previously Treated Advanced NSCLC with EGFR/Other Genomic Alterations

P2.10A.06 Phase 3 TroFuse-004 Study: Sac-TMT vs Chemotherapy for Previously Treated Advanced NSCLC with EGFR/Other Genomic Alterations

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The document outlines the TroFuse-004 study, a phase 3 clinical trial comparing the efficacy and safety of Sac-TMT (MK-2870/SKB264) against standard chemotherapy for patients with advanced non-small-cell lung cancer (NSCLC) who have presented with epidermal growth factor receptor (EGFR) mutations or other genomic alterations such as ALK, ROS1, and BRAF V600E. These patients had previously undergone treatment with tyrosine kinase inhibitors (TKIs) and experienced progression. Sac-TMT, an antibody-drug conjugate, targets the TROP2 antigen, and aims to enhance tumor suppression through a cytotoxic component, KL610023, which arrests cell growth and induces apoptosis.<br /><br />The study measures outcomes using primary endpoints such as progression-free survival (PFS) and overall survival (OS) in patients with EGFR-mutant NSCLC. Secondary measures across all NSCLC patients include objective response rates, duration of response, patient-reported outcomes, and safety evaluations.<br /><br />The study enrolls 556 patients, randomized in a 1:1 ratio to receive either Sac-TMT or standard chemotherapy (docetaxel or pemetrexed). Eligibility requires age above 18, documented NSCLC with exon 19del or exon 21 L858R EGFR mutations, and progression post-TKIs and chemotherapy treatments. Notably, patients with untreated active central nervous system metastases or those previously treated with a TROP2-targeted therapy are excluded. <br /><br />Initiated in November 2023, the trial is being conducted at 29 sites with a planned expansion to 193 sites. The statistical analysis will use intention-to-treat methodology, assessing PFS and OS via Kaplan-Meier and stratified log-rank tests. This ongoing trial aims to provide evidence for the potential advantages of Sac-TMT over traditional chemotherapy in specific NSCLC patient populations.

Asset Subtitle

Edward Garon

Meta Tag

Speaker Edward Garon

Topic Metastatic NSCLC – Cytotoxic Therapy

Keywords

TroFuse-004 study

phase 3 clinical trial

Sac-TMT

NSCLC

EGFR mutations

tyrosine kinase inhibitors

TROP2 antigen

progression-free survival

overall survival

intention-to-treat