TACTI-004
Research type
Research Study
Full title
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 pembrolizumab (PD-1 antagonist) and chemotherapy.
IRAS ID
1010938
Contact name
Regulatory Affairs Department
Contact email
Sponsor organisation
Immutep S.A.S.
Research summary
Advanced or metastatic non-small cell lung cancer refers to a type of lung cancer that has spread to other parts of the body or returned after successful treatment. Even with best current treatments advanced lung cancer remains a deadly disease.
Eftilagimod alfa (efti) is a new drug that boosts the immune system to kill cancer cells.
Pembrolizumab plus chemotherapy is today’s standard treatment for late-stage lung cancer. Pembrolizumab helps the immune system to see and attack cancer cells. Chemotherapy stops cancer cells from multiplying. This helps stop tumours from growing and kills the cancer cells. The remains of the dying cancer cells then trigger the body’s immune system.
When all 3 drugs (efti, pembrolizumab & chemotherapy) are given together, their combined effects may help immune cells to find and kill remaining cancer cells that are resistant to chemotherapy.
Study TACTI-004 aims to show that adding the test drug efti to standard treatment will be better for patients compared to adding placebo (looks like efti but without active substance) by comparing how long patients live and how long it takes for the cancer to grow or spread after receiving treatment.
Patients will be put into 2 groups by chance (randomised) to receive either efti plus standard treatment or placebo plus standard treatment. This trial will be “double-blinded”. This means that neither patients nor doctors will know who receives efti or placebo. Patients will be treated for up to 2 years. After stopping treatment, patients will be monitored on the study to see how they are doing.
The assessments include evaluation of medical history, documenting of side effects, physical examinations, vital signs, ECGs, blood and urine tests, pregnancy tests, questionnaires, tumour biopsy if archival sample is not available, CT/MRI and bone scans.
756 patients will participate in the study at 170 sites worldwide with 4 sites in the UK.REC name
North of Scotland Research Ethics Committee 1
REC reference
24/NS/0127
Date of REC Opinion
2 Dec 2024
REC opinion
Further Information Favourable Opinion