NCT06726265
TACTI-004, a double-blinded, randomized phase 3 trial in patients with advanced/metastatic non-small cell lung cancer (NSCLC) receiving eftilagimod alfa (MHC class II agonist) in combination with KEYTRUDA® (PD-1 antagonist) and chemotherapy.
Recruiting
Trial Overview
TACTI-004 (Two ACTive Immunotherapies-004) is a double-blinded, randomized phase 3 trial in patients with non-small cell lung cancer (NSCLC). The purpose of this study is to compare eftilagimod alfa (efti) in combination with pembrolizumab (KEYTRUDA®) and chemotherapy versus placebo in combination with pembrolizumab (KEYTRUDA®) and chemotherapy as first line treatment in adults with metastatic or advanced NSCLC.
The proposed clinical trial aims to compare the efficacy and to demonstrate the superiority of efti combined with standard of care (pembrolizumab [KEYTRUDA®] and chemotherapy) compared to placebo combined with standard of care regardless of PD-L1 expression (TPS 0-100%) in non-squamous or squamous tumours as assessed by:
- Overall survival [OS]
- Progression-free survival [PFS]
The trial is planned to be conducted in approximately 175 experienced clinical sites across countries in Asia, Australia, Europe, and North and South America.
Eligibility Information
Condition
Advanced/Metastatic Non-Small Cell Lung Carcinoma (NSCLC)
Age
18 years and older
Sex
All
Treatment Arms
| Study Arms | Assigned Intervention |
|---|---|
| Treatment Arm | Efti, pembrolizumab (KEYTRUDA®), Chemotherapy |
| Control Arm | Placebo, pembrolizumab (KEYTRUDA®), Chemotherapy |
Locations for this study
Enter a location and the closest results will be shown below. Note: the current list of 61 sites is incomplete and additional sites across multiple countries will continually be added, eventually reaching over 150 sites in over 25 countries globally.
Tasman Oncology Research Ltd
Pacific Private Cl, Ste 301 123 Nerang Street, Southport QLD 4215
Australia
Multiprofile Hospital for Active Treatment – Dobrich AD
Ulitsa Panayot Hitov 24, Dobrich, 9300
Bulgaria
Multiprofile Hospital For Active Treatment „Dr. Tota Venkova“ AD
Iliev Detskiya Str 1 Dr, Gabrovo, 5300
Bulgaria
Multiprofile Hospital for Active Treatment Serdika EOOD
Център, Damyan Gruev St 6, 1303 Sofia
Bulgaria
Unite de recherche clinique du CISSS des Laurentides
290 Rue de Montigny, Saint-Jérôme, QC J7Z 5T3
Canada
Klinicka Bolnica Centar – Sestre Milosrdnice – Klinika Za Tumore (University Hospital for Tumors)
Ilica 197, 10000, Zagreb,
Croatia
Klinički Bolnički Centar Zagreb – Klinika Za Plućne Bolesti Jordanovac
Jordanovac 104, 10000, Zagreb
Croatia
HCG Cancer Centre – Double Road (Bangalore Institute of Oncology (BIO))
No 44-45/2, 2 Cross, Rajaram Mohan Roy Extension (Off Lalbagh Double Road), Bengaluru, Karnataka – 560027
India
Geri Care Hospital T.Nagar
8, Dr Nair Rd, behind Vani Mahal, T. Nagar, Chennai, Tamil Nadu 600017
India
Sunact Cancer Institute Pvt. Ltd.
Ghodbunder Rd, Kasarvadavali, Thane West, Thane, Maharashtra 400615
India
Tata Memorial Centre – Mahamana Pandit Madan Mohan Malaviya Cancer Centre
Dr. E Borges Road, Parel, Mumbai
India
Istituto per la Ricerca e la Cura del Cancro (IRCC) – Istituto di Candiolo
SP142, km 3,95, 10060 Candiolo TO
Italy
Istituto Nazionale Tumori (INT) “Fondazione G. Pascale” di Napoli
Via Mariano Semmola, 52, 80131 Napoli NA
Italy
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Eivenių g. 2, Kaunas, 50161 Kauno m. sav.
Lithuania
Paula Stradiņa Klīniskā Universitātes Slimnīca
Pilsoņu iela 13, Zemgales priekšpilsēta, Rīga, LV-1002
Latvia
Unidade Local de Saude de Santa Maria, EPE – Hospital Pulido Valente
Alameda das Linhas de Torres 117, 1769-001 Lisboa
Portugal
Spitalul Memorial Healthcare International
Șoseaua Gheorghe Ionescu Sisești 8A, București 013812
Romania
Victoria Hospital – Centrul de Oncologie Euroclinic SRL
Strada Vasile Conta nr. 2, Iași 700110
Romania
Hospital Universitari Germans Trias i Pujol
Carretera de Canyet, s/n, 08916 Badalona, Barcelona
Spain
Hospital de la Santa Creu i Sant Pau
Carrer de Sant Quintí, 89, Horta-Guinardó, 08025 Barcelona
Spain
Hospital Regional Universitario de Málaga – Hospital General
Av. de Carlos Haya, 84, Bailén-Miraflores, 29010 Málaga
Spain
National Trial Reference Number
NCT06726265
EU CT Number
2024-513621-23-00