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)

Phase 3

Recruiting

• Conditions: Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
• Interventions: Drug: carboplatin plus paclitaxel; Biological: eftilagimod alfa; Drug: cisplatin or carboplatin + pemetrexed; Biological: Pembrolizumab (KEYTRUDA®); Other: Placebo

• Registration Number: NCT06726265
• Lead Sponsor: Immutep S.A.S.

Brief 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.

Detailed Description

TACTI-004 is a double-blinded, randomized phase 3 trial in patients with advanced/metastatic non-small cell lung cancer (NSCLC) receiving eftilagimod alfa (major histocompatibility complex (MHC) class II agonist) in combination with pembrolizumab (programmed cell death protein 1 (PD-1) antagonist) and chemotherapy.

The proposed clinical trial aims to compare the efficacy and to demonstrate the superiority of efti combined with standard of care (SoC, pembrolizumab and histology-based chemotherapy) compared to placebo combined with SoC in programmed death-ligand 1 (PD-L1) unselected population as assessed by:

* Overall survival \[OS\]

* Progression-free survival \[PFS\] per RECIST 1.1

The trial is planned to be conducted in countries in Asia, Australia, Europe and North and South America in approximately 175 experienced clinical sites.

Study Timeline

• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-05
• Study First Posted: 2024-12-10
• Study Start: 2025-03-21
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-01
• Last Update Posted: 2025-08-06
• Primary Completion: 2027-06
• Study Completion: 2029-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 756

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
efti + Standard of Care arm	cisplatin or carboplatin + pemetrexed	Combination of efti, pembrolizumab (KEYTRUDA®) and histology-based platinum doublet chemotherapy
Placebo + Standard of Care arm	carboplatin plus paclitaxel	Combination of efti-matching placebo, pembrolizumab (KEYTRUDA®) and histology-based platinum doublet chemotherapy
Placebo + Standard of Care arm	cisplatin or carboplatin + pemetrexed	Combination of efti-matching placebo, pembrolizumab (KEYTRUDA®) and histology-based platinum doublet chemotherapy
efti + Standard of Care arm	eftilagimod alfa	Combination of efti, pembrolizumab (KEYTRUDA®) and histology-based platinum doublet chemotherapy
efti + Standard of Care arm	carboplatin plus paclitaxel	Combination of efti, pembrolizumab (KEYTRUDA®) and histology-based platinum doublet chemotherapy
efti + Standard of Care arm	Pembrolizumab (KEYTRUDA®)	Combination of efti, pembrolizumab (KEYTRUDA®) and histology-based platinum doublet chemotherapy
Placebo + Standard of Care arm	Pembrolizumab (KEYTRUDA®)	Combination of efti-matching placebo, pembrolizumab (KEYTRUDA®) and histology-based platinum doublet chemotherapy
Placebo + Standard of Care arm	Placebo	Combination of efti-matching placebo, pembrolizumab (KEYTRUDA®) and histology-based platinum doublet chemotherapy

Primary Outcome Measures

Name	Time	Method
Determination of Overall survival (OS)	Up to approximately 54 months
Determination of Progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	Up to approximately 54 months

Secondary Outcome Measures

Name	Time	Method
Determination of Objective response rate (ORR) per RECIST 1.1	Up to approximately 54 months
Frequency of adverse events (AEs)	Up to approximately 27 months
Severity of adverse events (AEs) according to the United States National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v5.0	Up to approximately 27 months
Determination of Time to Response (TTR) by RECIST 1.1.	Up to approximately 54 months
Determination of Duration of Response (DOR) by RECIST 1.1.	Up to approximately 54 months
Determination of PFS on next line therapy (PFS2)	Up to approximately 54 months

Trial Locations

Locations (79)

Antwerp University Hospital; 🇧🇪 Antwerp, Belgium

McGill University - Jewish General Hospital (JGH) - Lady Davis Institute for Medical Research; 🇨🇦 Montréal, Canada

High-tech Hospital Med Center; 🇬🇪 Batumi, Georgia

High Technology Medical Center, University Clinic; 🇬🇪 Tbilisi, Georgia

Institute of Clinical Oncology; 🇬🇪 Tbilisi, Georgia

Mardaleishvili Medical Centre; 🇬🇪 Tbilisi, Georgia

Chittaranjan National Cancer Institute; 🇮🇳 Kolkata, India

Regional Cancer Centre Thiruvananthapuram; 🇮🇳 Thiruvananthapuram, India

Hospital Tengku Ampuan Afzan; 🇲🇾 Kuantan, Malaysia

Hospital Umum Sarawak - Clinical Research Centre; 🇲🇾 Kuching, Malaysia

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