A phase III placebo-controlled study of eftilagimod alfa plus pembrolizumab and chemotherapy in metastatic non-small cell lung cancer
Year: 2025
Type: article
Study design: Study Protocol
Abstract: BACKGROUND: Although immune checkpoint inhibitors (ICIs) form the cornerstone of first-line treatment for non-small cell lung cancer (NSCLC), the challenge remains to improve patients' long-term outcomes. Eftilagimod alfa (efti) activates antigen-presenting cells, triggering T cell activation and a sustained immune response. Prior studies combining efti with an ICI, pembrolizumab, have shown encouraging efficacy, especially in PD-L1 low (tumor proportion score [TPS] 1-49%) and negative (<1%) tumors. TACTI-004 is a global double-blinded, randomized, placebo-controlled phase III study investigating efti plus standard-of-care (SoC: pembrolizumab plus chemotherapy) in first-line NSCLC, regardless of PD-L1 expression (TPS 0-100%). PATIENTS AND METHODS: About 756 participants with squamous or non-squamous first-line NSCLC, not amenable to EGFR/ROS1/ALK-targeted therapy, will be randomized to receive either efti plus SoC or placebo plus SoC. The dual primary endpoint is progression-free survival and overall survival. Key secondary endpoints include objective response rate, duration of response and safety. Participants will receive 30 mg efti subcutaneously every 2 weeks (q2w) for 24 weeks, then q3w and pembrolizumab 200 mg intravenously q3w, both for up to 2 years. Chemotherapy choice will be histology-dependent. CONCLUSIONS: TACTI-004 will evaluate whether efti can mitigate resistance to ICIs when added to SoC in NSCLC, irrespective of PD-L1 tumor status. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov identifier is NCT06726265.
Source: Future Oncology
Institutions: Queensland University of Technology, Greenslopes Private Hospital, Gallipoli Medical Research Foundation, Hospital Universitario Central de Asturias, Riga East University Hospital, Grigore T. Popa University of Medicine and Pharmacy, Fondazione IRCCS Istituto Nazionale dei Tumori, National and Kapodistrian University of Athens, Laiko General Hospital of Athens, Krankenhaus Nordwest, University Hospital Frankfurt, Frankfurt Cancer Institute, Hospital de Sant Pau
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W4417266524