2024 World Conference on Lung Cancer (WCLC) - Posters-P4.07D.04 Trofuse-019: A Phase 3 Study of Adjuvant Pembrolizumab with or without Sac-TMTfor Resectable Stage II-IIIB (N2) NSCLC

P4.07D.04 Trofuse-019: A Phase 3 Study of Adjuvant Pembrolizumab with or without Sac-TMTfor Resectable Stage II-IIIB (N2) NSCLC

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The document details TroFuse-019, a Phase 3 clinical study evaluating the efficacy of pembrolizumab, with or without sacituzumab tirumotecan (sac-TMT), in patients with resectable stage II–IIIB (N2) non-small-cell lung cancer (NSCLC) who have not achieved pathologic complete response (pCR) after neoadjuvant pembrolizumab and chemotherapy followed by surgery. The study is sponsored by Merck & Co.<br /><br />Sacituzumab tirumotecan is an antibody-drug conjugate targeting TROP2, a protein linked to cancer cell growth and poor prognosis in high TROP2-expressing NSCLC. Pembrolizumab is already used in combination with chemotherapy for NSCLC treatment. The study aims to assess whether the addition of sac-TMT could improve outcomes such as disease-free survival, overall survival, and distant metastasis-free survival compared to pembrolizumab alone. <br /><br />The trial enrolled patients meeting specific criteria, including those with histologically confirmed stage II–IIIB disease, specified performance status, and prior surgery without achieving pCR. Participants are stratified based on tumor histology, PD-L1 expression, and TROP2 levels. Patients are randomized to receive either pembrolizumab with sac-TMT or pembrolizumab alone. <br /><br />Key assessments include radiological imaging and safety evaluations, while quality of life measures are gathered using questionnaires. Statistical analyses will utilize stratified log-rank tests and the Kaplan-Meier method to estimate efficacy endpoints. Enrollment began in April 2024 and involves 260 sites. <br /><br />The study seeks to determine the potential benefits of additional adjuvant therapy in this patient population, providing insights into effective management strategies for NSCLC. For further information, contact Dr. Jay M. Lee or consult referenced materials.

Asset Subtitle

JAY LEE

Meta Tag

Speaker JAY LEE

Topic Early-Stage NSCLC

Keywords

TroFuse-019

pembrolizumab

sacituzumab tirumotecan

non-small-cell lung cancer

NSCLC

TROP2

disease-free survival

clinical study

Merck & Co.

adjuvant therapy