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: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2027-06
• Study Completion: 2029-09

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
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
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

Trial Locations

Locations (20)

Algemeen Ziekenhuis Maria Middelares; 🇧🇪 Gent, Belgium

Clinique et Maternité Sainte-Elisabeth; 🇧🇪 Namur, Belgium

Multiprofile Hospital for Active Treatment - Dobrich AD; 🇧🇬 Dobrich, Bulgaria

Complex Oncology Center Ruse; 🇧🇬 Ruse, Bulgaria

Multiprofile Hospital for Active Treatment Serdika EOOD; 🇧🇬 Sofia, Bulgaria

Sunact Cancer Institute Pvt. Ltd.; 🇮🇳 Thane, India

Latvian Oncology Center; 🇱🇻 Riga, Latvia

Paula Stradiņa Klīniskā Universitātes Slimnīca; 🇱🇻 Riga, Latvia

Instytut Medyczny Santa Familia Sp. z o. o. w Łodzi; 🇵🇱 Lodz, Poland

IP Clinic Sp. z o.o.; 🇵🇱 Lodz, Poland

Centrul Medical Medicover Victoria; 🇷🇴 Bucharest, Romania

Spitalul Memorial Healthcare International; 🇷🇴 Bucharest, Romania

Onco Clinic Consult SA; 🇷🇴 Craiova, Romania

Victoria Hospital - Centrul de Oncologie Euroclinic SRL; 🇷🇴 Iasi, Romania

Parc Tauli Hospital Universitari; 🇪🇸 Sabadell, Spain

Lyell McEwin Hospital; 🇦🇺 Elizabeth Vale, Australia

Greenslopes Private Hospital; 🇦🇺 Greenslopes, Australia

Tasman Oncology Research Ltd; 🇦🇺 Southport, Australia

Calvary Mater Newcastle; 🇦🇺 Waratah, Australia

Cancer Care Wollongong Pty Limited; 🇦🇺 Wollongong, Australia