TACTI-004

About this trial

Background:
Eftilagimod Alfa (Efti) is a major histocompatibility compex (MHC) class II agonist. MHC Class II agonist molecules bind to Antigen Presenting Cells (APCs) and activate the immune system leading to the presentation of tumour antigens to T Cells and promoting and anti-tumour response. Pembrolizumab is a monoclonal antibody that targets the PD-1 protein on T cells. By blocking PD-1, pembrolizumab releases the brakes on the immune system, allowing T cells to better recognize and attack cancer cell.
Efti is being investigated in combination with pembrolizumab for Non-Small Cell Lung Cancer (NSCLC). The rationale for their combined use is that Efti can boost the overall immune response potentially enchancing the effectiveness of pembrolizumab in NSCLC.
Purpose:
In this trial patients will either recieve Efti with Standard of Care Treatment (Pembrolizumab and platinum doublet chemotherapy) or a Placebo with Standard of Care Treatment. The Clinical Trial will compare the efficacy of Efti with Standard of Care compared to placebo and standard of care in Adults with advanced/metastatic NSCLC.

Patients who are eligible to participate on this study will be assigned by chance (one chance in two) to one of two treatment groups via a process called randomization. Patients assigned to treatment group one will receive Efti with Standard of Care Treatment. Patients assigned to treatment group two will receive placebo with Standard of Care Treatment. Patients will be asked to visit the study doctor for study treatment for just over 2 years, as long as their cancer is not getting worse or they do not have serious side effects. About 756 people will be in the study in total.

Patient Profile

Advanced/Metastatic Non Small Cell Lung Cancer

Where’s this trial being run?

Beaumont Hospital, Cork University Hospital, Tallaght University Hospital, and Mater Misericordiae University Hospital

Can I join this study / trial?

The first step we recommend is to talk to your doctor or the cancer trials team at your hospital. You can find contact details for cancer trials research units in Ireland here.

It’s also a good idea to print this page and bring it with you to your appointment. It can help guide the conversation and remind you of what to ask. You may also want to talk to your family or friends about your options, as they can offer support as you make decisions.

For more detailed information

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Questions?

Here’s a list of questions you may have for your doctor or local cancer research team.

Questions

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Summary Data

Name:	TACTI-004
Number:	24-20
Full Title:	TACTI-004: A Double Blinded, Randomised, Phase 3 Trials in Patients with  Advanced/Metastatic Non Small Cell Lung Cancer receiving Eftilagimod Alfa  (MHC Class II Agonist) in Combination with Pembrolizumab and Chemotherapy

Principal Investigator:	Prof Jarushka Naidoo
Type:	Industry Sponsored
Sponsor:	IMMUTEP S.A.S.
Recruitment Started:	Global: Ireland: March 2025

Global Recruitment Target:	756
Ireland Recruitment Target:	13