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NCT06726265 · ClinicalTrials.gov record · last posted 2026-03-18

Study of Eftilagimod Alfa (Efti) in Combination With Pembrolizumab and Chemotherapy Versus Placebo in Combination With Pembrolizumab and Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) (TACTI-004)

StatusActive, Not Recruiting
PhasePhase 3
Started2025-03-21
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
The purpose of this study is to compare eftilagimod alfa (efti) in combination with pembrolizumab and chemotherapy versus placebo in combination with pembrolizumab and chemotherapy with respect to overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) among adults with metastatic non-small cell lung cancer (NSCLC). Participants will receive either efti plus standard treatment (pembrolizumab and platinum doublet chemotherapy) or placebo plus standard treatment and will be treated for up to 2 years.

Amendment record 12 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 12 times since 2024-12-05; most recent amendment 2026-03-17. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2026-03-17
Status change Recruiting→Active, Not Recruitingv12
2025-03-27
Status change Not Yet Recruiting→Recruitingv1
Trial Details
NCT Number NCT06726265
Lead Sponsor Immutep S.A.S.
Collaborators: Merck Sharp & Dohme LLC
Conditions Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
Enrollment 756 participants
Start Date 2025-03-21
Primary Completion 2027-06 (estimated)
Study Completion 2029-09 (estimated)
Updated on ClinicalTrials.gov 2026-03-18