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ACTIVE NOT RECRUITING Phase 3

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)

NCT06726265 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • OTHER Placebo
  • BIOLOGICAL eftilagimod alfa
  • DRUG carboplatin plus paclitaxel
  • DRUG cisplatin or carboplatin + pemetrexed
  • BIOLOGICAL pembrolizumab (KEYTRUDA®)

Study Locations (20)

Other

  • Centro de Endocrinologia y Diabetes Dr. Raul A. Gutman SRL — Buenos Aires
  • Fundacion Respirar — Buenos Aires
  • Hospital Británico de Buenos Aires — Buenos Aires
  • Sanatorio Parque - Rosario — Rosario
  • Clinica Viedma — Viedma
  • Lyell McEwin Hospital — Elizabeth Vale
  • Greenslopes Private Hospital — Greenslopes
  • The Alfred Hospital — Melbourne
  • Tasman Oncology Research Ltd — Southport
  • St John of God Subiaco Hospital — Subiaco
  • Royal Darwin Hospital — Tiwi
  • Calvary Mater Newcastle — Waratah
  • Cancer Care Wollongong Pty Limited — Wollongong
  • Landeskrankenhaus-Universitätsklinikum Graz, KLinische Abteilung für Pulmonologie — Graz
  • Vienna General Hospital — Vienna
  • Antwerp University Hospital — Antwerp
  • Algemeen Ziekenhuis Maria Middelares — Ghent

Kentucky

  • Norton Cancer Institute - Audubon — Louisville

New Mexico

  • New Mexico Oncology Hematology Consultants, Ltd. — Albuquerque

Texas

  • Ascension Seton Infusion Center — Austin

Trial Details

FieldValue
Enrollment Target 756 participants
Start Date 2025-03-21
Est. Completion 2029-09
Phase Phase 3

Sponsor

Immutep S.A.S.

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06726265

The ClinicalTrials.gov registry entry for NCT06726265 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 756 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Immutep S.A.S., which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) appearing as the primary indexed condition, and to 5 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06726265 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Other, Kentucky, New Mexico. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06726265 about?

NCT06726265 is a clinical study titled "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)". 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 Tum...

What is the current status of trial NCT06726265?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 756 participants. The study started on 2025-03-21. Estimated completion is 2029-09.

What conditions does trial NCT06726265 study?

This clinical trial studies the following conditions: Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06726265?

The interventions under investigation include: Placebo (OTHER), eftilagimod alfa (BIOLOGICAL), carboplatin plus paclitaxel (DRUG), cisplatin or carboplatin + pemetrexed (DRUG), pembrolizumab (KEYTRUDA®) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06726265?

This trial is sponsored by Immutep S.A.S., which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06726265 being conducted?

This trial has 20 study locations across Kentucky, New Mexico, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial