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Study on Tedopi and Nivolumab for Patients with Advanced Non-Small Cell Lung Cancer After Initial Treatment

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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 treatments for metastatic non-small-cell lung cancer, a type of lung cancer that has spread to other parts of the body. The study is testing the effectiveness of a combination of treatments to see how well they work as a second-line therapy, which means they are used after the first treatment has not been successful. The treatments being studied include Tedopi, a cancer vaccine, combined with either docetaxel, a chemotherapy drug, or nivolumab, an immunotherapy drug also known by its code name BMS936558. There is also a group receiving only docetaxel.

The purpose of the study is to evaluate the 1-year survival rate of patients receiving these treatments. Participants will be randomly assigned to one of the treatment groups. The study will monitor patients over time to see how the cancer responds to the treatments and to check for any side effects. The study will also look at overall survival rates, how long patients live without the cancer getting worse, and the response of the cancer to the treatments. Additionally, the study will explore the relationship between these outcomes and specific markers found in the tumors.

The trial is expected to continue until 2026, with patients being monitored for their health and response to the treatments. The study aims to provide valuable information on the effectiveness of these treatment combinations for patients with advanced lung cancer who have not responded to initial treatments.

The research process

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

Step 1
Randomization
Upon joining the study, participants are randomly assigned to one of three groups. Each group receives a different treatment combination for metastatic non-small-cell lung cancer.
Step 2
Treatment administration
Participants in arm A receive Tedopi plus docetaxel. Docetaxel is administered intravenously, typically once every three weeks.
Participants in arm B receive Tedopi plus nivolumab. Nivolumab is administered intravenously, usually every two weeks.
Participants in arm C receive docetaxel as a single agent, administered intravenously once every three weeks.
Step 3
Treatment duration
The treatment continues until there is evidence of disease progression, unacceptable side effects, or the participant decides to withdraw from the study.
Step 4
Follow-up assessments
Regular assessments are conducted to monitor the participant's health and the effectiveness of the treatment. These assessments include imaging tests and laboratory evaluations.
Step 5
End of study
The study aims to assess the 1-year survival rate and other outcomes such as overall survival, progression-free survival, and response rate. The study is estimated to conclude by May 17, 2026.

Who can join the trial?

13 criteria

Male and female patients must be willing and able to give written informed consent.
Patients must have a normal level of creatinine, which is a waste product in the blood that comes from muscle activity.
Female patients must not be able to have children due to surgery, radiation, menopause, or must use highly effective birth control methods during treatment. Male patients must practice complete abstinence or use highly effective birth control methods if sexually active with women who can have children, and they should not donate semen.
If patients had palliative radiotherapy (a type of radiation treatment to relieve symptoms) to areas outside the brain, it must have been completed at least 2 weeks before treatment. If they have brain metastases, these must be treated and the patient should be back to their normal state for at least 2 weeks before starting the trial.
Patients must either not be taking corticosteroids (a type of medication) or be on a stable or decreasing dose of 10 mg or less of prednisone (or equivalent) daily for at least 2 weeks before starting the trial.
Patients must have a confirmed diagnosis of a specific type of lung cancer called HLA-A2+ NSCLC, with no evidence of certain genetic mutations or rearrangements.
Patients must show disease progression after at least 4 cycles of chemoimmunotherapy or a specific regimen and be eligible for treatment with a drug called docetaxel.
Patients must have experienced disease progression during or within 3 months of stopping treatment with anti-PD-(L)1-based therapy, after previously benefiting from it or having stable disease.
Patients must have a performance status of 0-1, which means they are fully active or have some restrictions but can still carry out light work.
Patients must be able to comply with trial procedures.
Patients must be at least 18 years old.
Patients must have adequate bone marrow function, which means having enough healthy blood cells.
Patients must have adequate liver function, meaning their liver is working well enough, with specific levels of bilirubin and liver enzymes.

Who cannot join the trial?

4 criteria

Patients who have a different type of cancer than metastatic non-small-cell lung cancer. This means the cancer has spread from the lungs to other parts of the body.
Patients who have not received first-line chemoimmunotherapy. This is the initial treatment combining chemotherapy and immunotherapy.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Azienda Ospedaliera Universitaria Senese
Siena, Italy
Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Istituto Oncologico Veneto
Padua, Italy

Trial locations

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Investigated drugs

Tedopi
is a therapeutic vaccine designed to help the immune system recognize and fight cancer cells. It is used in this trial to treat patients with advanced non-small-cell lung cancer (NSCLC) who have not responded to initial treatments.
Docetaxel
is a type of chemotherapy drug that works by stopping cancer cells from growing and dividing. It is used in this trial as a treatment option for patients with advanced NSCLC.
Nivolumab
is an immunotherapy drug that helps the immune system attack cancer cells. It is used in this trial in combination with Tedopi to treat patients with advanced NSCLC.

What is already known about the treatment

Tedopi
Tedopi is administered as an injection and is currently being evaluated in clinical trials for its effectiveness in treating metastatic non-small-cell lung cancer. It is not yet widely used in standard medical practice but is being studied for its potential benefits. The main therapeutic indication for Tedopi is as a second-line treatment for patients whose cancer has progressed after initial chemo-immunotherapy. Tedopi works by stimulating the immune system to recognize and attack cancer cells, enhancing the body's natural defenses. It is classified as an immunotherapy agent.
Docetaxel
Docetaxel is administered intravenously and is a well-established chemotherapy drug used in the treatment of various cancers, including metastatic non-small-cell lung cancer. It is commonly used in medical practice and is part of the standard treatment regimen for this type of cancer. The main therapeutic indication for docetaxel is to slow or stop the growth of cancer cells. It works by interfering with the microtubule structures within the cell, which are essential for cell division, thereby inhibiting cancer cell proliferation. Docetaxel is classified as a taxane-based chemotherapy agent.
Nivolumab
Nivolumab is administered as an intravenous infusion and is an approved medication used in the treatment of several types of cancer, including metastatic non-small-cell lung cancer. It is widely recognized in medical literature and practice for its role in cancer therapy. The main therapeutic indication for nivolumab is to enhance the immune system's ability to fight cancer. It works by blocking the PD-1 protein on immune cells, preventing cancer cells from evading immune detection. Nivolumab is classified as a checkpoint inhibitor, a type of immunotherapy.

Investigated diseases

Metastatic Non-Small-Cell Lung Cancer – This is a type of lung cancer that has spread from the lungs to other parts of the body. It originates in the tissues of the lungs and is characterized by the presence of larger cells when viewed under a microscope. As the disease progresses, cancer cells can travel through the bloodstream or lymphatic system to form tumors in other organs. This type of cancer is known for its ability to grow and spread rapidly. Symptoms may include persistent cough, chest pain, and difficulty breathing. The progression of the disease can vary, with some patients experiencing a slow spread while others may see a more rapid advancement.