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Study of Eftilagimod Alfa with Pembrolizumab and Chemotherapy for Patients with Advanced Non-Small Cell Lung Cancer

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of lung cancer known as advanced/metastatic non-small cell lung cancer (NSCLC). The study is testing a new drug called eftilagimod alfa, also known as efti, in combination with other treatments that are already available, such as pembrolizumab and chemotherapy. Pembrolizumab is a medication that helps the immune system fight cancer, and chemotherapy is a common treatment that uses drugs to kill cancer cells.

The purpose of this study is to compare the effectiveness of the combination of efti, pembrolizumab, and chemotherapy against the standard treatments currently used for this type of lung cancer. Participants in the study will receive either the new combination of treatments or the standard treatments. Some participants may receive a placebo, which looks like the treatment but does not contain any active medication. The study will be conducted over a period of time, and participants will be monitored regularly to assess their response to the treatment and any side effects they may experience.

Throughout the study, participants will undergo various assessments to track their health and the progress of their cancer. These assessments will help researchers understand how well the new treatment combination works compared to the standard treatments. The study aims to provide valuable information that could lead to improved treatment options for patients with advanced/metastatic non-small cell lung cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The trial begins with the administration of the new drug eftilagimod alfa (also known as efti) in combination with pembrolizumab and chemotherapy. Eftilagimod alfa is given as a solution for injection under the skin (subcutaneous use).

    Pembrolizumab, a medication that helps the immune system fight cancer, is administered as an intravenous infusion. This means it is given directly into a vein through a drip.

    Chemotherapy drugs such as carboplatin, pemetrexed, cisplatin, and paclitaxel are also administered as intravenous infusions. These drugs are used to kill or stop the growth of cancer cells.

  2. Step 2

    Treatment schedule

    The treatment is given in cycles. Each cycle lasts for a specific period, during which the medications are administered according to a set schedule.

    The exact dosage and frequency of each medication depend on the specific protocol of the trial and the patient's response to the treatment.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, regular monitoring and assessments are conducted to evaluate the patient's response to the treatment.

    This includes physical examinations, blood tests, and imaging studies to check the size and spread of the cancer.

    The patient's overall health and any side effects experienced are also closely monitored.

  4. Step 4

    Continuation or adjustment of treatment

    Based on the results of the assessments, the treatment plan may be continued, adjusted, or stopped.

    If the cancer responds well to the treatment, the same regimen may be continued. If there are significant side effects or if the cancer does not respond, adjustments may be made.

  5. Step 5

    End of trial participation

    The trial is expected to continue until 2029, but individual participation may end earlier depending on the patient's response and health status.

    At the end of participation, a final assessment is conducted to evaluate the overall outcome of the treatment.

Who can join the trial?

16 criteria

  • Willing to give written informed consent and follow the study rules.
  • Have a disease that can be measured, as determined by the study site.
  • Recovered from side effects of previous cancer treatments to a mild level or back to normal. Some exceptions apply, like mild nerve damage, hair loss, or liver issues due to cancer spread.
  • If you had major surgery before the study, you must have recovered well from it.
  • If you have hepatitis B, you must have been on antiviral treatment for at least 4 weeks and have no detectable virus in your blood before starting the study.
  • If you had hepatitis C, the virus must not be detectable in your blood at the start of the study, and you must have finished treatment at least 4 weeks before.
  • If you have HIV, you must be on treatment, have a well-controlled infection, and meet specific health criteria, like a certain level of immune cells and no recent serious infections.
  • Your organs must be working well, as defined in the study rules, with tests done within 10 days before starting the study.
  • Have a confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) that cannot be cured or treated with specific first-line therapies. You should not have had systemic treatment for advanced cancer, but previous radiation for advanced cancer is allowed.
  • Provide a sample of tumor tissue, either from a previous biopsy or a new one, that has not been treated with radiation.
  • Have a test result for a specific marker (PD-L1) from a central lab using an approved test.
  • Be at least 18 years old on the day you sign the consent form.
  • If you can produce sperm, agree to use contraception during the study and for a specified time after the last dose of study drugs, or abstain from sexual intercourse.
  • If you can become pregnant, you must not be pregnant, have a negative pregnancy test before starting the study, and use effective contraception or abstain from sexual intercourse during the study and for a specified time after the last dose of study drugs. You must also agree not to donate eggs during this time.
  • Have a good level of daily functioning, assessed within 7 days before starting the study.
  • Have an expected survival of more than 3 months.

Who cannot join the trial?

15 criteria

  • Patients who have a different type of cancer than the one being studied, which is called advanced/metastatic non-small cell lung cancer (NSCLC).
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specific group being studied.
  • Patients who are not able to give informed consent or understand the study requirements.
  • Patients who have other medical conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who are taking medications that might interfere with the study treatment.
  • Patients who have allergies to the study medications.
  • Patients who have had a recent major surgery.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have a mental health condition that might interfere with the study.
  • Patients who have a history of heart problems that might interfere with the study.
  • Patients who have a history of lung problems that might interfere with the study.
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Investigated drugs

  • Eftilagimod alfa

    is an experimental medication being studied for its potential to help the immune system fight cancer. It works by activating certain immune cells, which may enhance the body's ability to attack cancer cells. In this trial, it is being tested in combination with other treatments to see if it can improve outcomes for patients with advanced lung cancer.

  • Pembrolizumab

    is a medication that helps the immune system recognize and attack cancer cells. It is known as a PD-1 antagonist, which means it blocks a specific protein on immune cells that can prevent them from attacking cancer. By blocking this protein, pembrolizumab can help the immune system better target and destroy cancer cells.

  • Chemotherapy

    refers to a group of medications used to kill or slow the growth of cancer cells. In this trial, chemotherapy is used alongside other treatments to see if the combination can be more effective in treating advanced lung cancer. Chemotherapy works by targeting rapidly dividing cells, which include cancer cells, to reduce the size of tumors and slow the progression of the disease.

What is already known about the treatment

  • Eftilagimod alfa

    This medication is administered through injection and is currently being studied in clinical trials for its potential use in treating advanced or metastatic non-small cell lung cancer (NSCLC). It is not yet widely used in standard medical practice but is gaining attention in medical literature. Eftilagimod alfa works by activating the immune system, specifically targeting MHC class II molecules to enhance the body's immune response against cancer cells. It is classified as an MHC class II agonist.

  • Pembrolizumab

    This medication is given by intravenous infusion and is already approved for use in various cancers, including advanced or metastatic non-small cell lung cancer (NSCLC). It is well-documented in medical literature and is used to help the immune system recognize and attack cancer cells. Pembrolizumab works by blocking the PD-1 pathway, which cancer cells use to hide from the immune system. It is classified as a PD-1 antagonist.

Investigated diseases

Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that begins in the cells lining the lungs and is characterized by its ability to spread to other parts of the body. It is termed "non-small cell" because the cancer cells are larger than those found in small cell lung cancer. In its advanced or metastatic stage, the cancer has spread beyond the lungs to other organs. The progression of the disease can vary, but it often involves the growth of tumors in the lungs and potentially in other areas such as the bones, brain, or liver. Symptoms may include persistent cough, chest pain, and difficulty breathing. The disease is typically diagnosed through imaging tests and biopsy, and its progression is monitored through regular medical evaluations.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513621-23-00Protocol codeTACTI-004Estimated enrolment756 patientsSponsorImmutep

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).