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Study Comparing OSE2101 and Docetaxel for Patients with Metastatic Non-Small Cell Lung Cancer After Immunotherapy Resistance

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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 metastatic Non-Small Cell Lung Cancer (NSCLC). The study is specifically for patients who have a certain genetic marker called HLA-A2 and have experienced a return of cancer after initial treatment with immune therapy. The trial will compare two treatments: a cancer vaccine called OSE2101 (also known by its code name TEDOPI) and a chemotherapy drug called docetaxel. The purpose of the study is to determine which treatment is more effective in helping patients live longer.

Participants in the study will receive either the cancer vaccine or the chemotherapy drug. The cancer vaccine, OSE2101, is given as an injection under the skin, while docetaxel is administered through an intravenous infusion, which means it is given directly into a vein. The study will last for up to 24 months, during which time the health and progress of the participants will be closely monitored by the research team. The main goal is to see which treatment helps patients live longer, regardless of the cause of death.

This study is important for patients with NSCLC who have not responded to previous immune therapy treatments. By comparing the cancer vaccine with chemotherapy, researchers hope to find a more effective treatment option for these patients. The trial will provide valuable information on the safety and effectiveness of OSE2101 compared to docetaxel, potentially leading to better treatment strategies for this type of lung cancer.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    Upon joining the study, the patient is randomly assigned to one of two treatment groups: one receiving the therapeutic cancer vaccine OSE2101 and the other receiving the chemotherapy drug docetaxel.

  2. Step 2

    Treatment administration

    Patients in the OSE2101 group receive the vaccine as a subcutaneous injection. The specific dosage and frequency are determined by the study protocol.

    Patients in the docetaxel group receive the drug intravenously. The dosage and frequency are also determined by the study protocol.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, patients undergo regular monitoring to assess their health and the effectiveness of the treatment. This includes physical examinations, blood tests, and imaging studies as required by the study protocol.

  4. Step 4

    Follow-up

    After completing the treatment phase, patients continue to be monitored for a specified period to evaluate long-term effects and overall survival. The duration of follow-up is determined by the study protocol.

Who can join the trial?

15 criteria

  • Must be a male or female aged 18 years or older.
  • If applicable, must have a break of at least 28 days or 5 half-lives (whichever is shorter) since the last cancer treatment or experimental therapy before starting the study treatment. Also, a break of at least 28 days after major surgery or definitive radiation, and at least 2 weeks after palliative radiation.
  • Women who can have children must agree to use very effective birth control methods before joining the study, during the study, and for 180 days after the last dose of study treatment. These methods include hormonal birth control that stops ovulation, intrauterine devices (IUDs), or other reliable methods.
  • Men with partners who can have children must agree to use condoms during the study and for 90 days after the last dose of study treatment. Their partners can use hormone-based birth control since they are not receiving the study treatment.
  • Women who can have children must have a negative pregnancy test during screening and within 24 hours before each study treatment. Women who are postmenopausal for at least 1 year or are surgically sterilized do not need this test.
  • Must have signed and dated an informed consent form before any trial-specific procedures.
  • Must be part of a social security system as required by local regulations.
  • Must have a specific blood type called **HLA-A2 phenotype** confirmed by a pre-screening test.
  • Must have a type of lung cancer called **Non-Small Cell Lung Cancer (NSCLC)** that has spread to other parts of the body and is not suitable for surgery or radiation. Must not have certain gene changes that allow for targeted therapy, unless there is no local access to such therapy.
  • Must have experienced cancer progression after at least 24 weeks of a specific first-line treatment, including at least 12 weeks of a type of therapy called **anti-PD(L)1**. A tumor assessment is needed to confirm this.
  • Must have stopped the specific therapy due to cancer progression after at least 24 weeks, including at least 12 weeks of **anti-PD(L)1** therapy.
  • Must have an **ECOG performance status** of 0 or 1, which indicates the ability to carry out daily activities.
  • Must have measurable or non-measurable cancer lesions according to a standard called **RECIST 1.1**.
  • Must have adequate organ function, which includes specific levels of proteins and enzymes in the blood, as well as certain blood cell counts and kidney function.
  • Must not have significant ongoing side effects from previous treatments, except for hair loss.

Who cannot join the trial?

4 criteria

  • Patients who do not have the HLA-A2 positive phenotype. This means their body does not have a specific type of protein on their cells.
  • Patients who do not have metastatic Non-Small Cell Lung Cancer. This is a type of lung cancer that has spread to other parts of the body.
  • 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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Investigated drugs

  • OSE2101

    is an investigational medication being studied for its potential to improve survival in patients with metastatic Non-Small Cell Lung Cancer (NSCLC) who have developed resistance to immune checkpoint inhibitors. It is designed to work by stimulating the immune system to better recognize and attack cancer cells.

  • Docetaxel

    is a chemotherapy medication commonly used to treat various types of cancer, including Non-Small Cell Lung Cancer (NSCLC). It works by interfering with the growth and division of cancer cells, ultimately leading to their death. In this trial, it is being used as a comparison to evaluate the effectiveness of OSE2101.

What is already known about the treatment

  • OSE2101

    OSE2101 is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating patients with a specific type of lung cancer known as metastatic Non-Small Cell Lung Cancer (NSCLC) who have a particular genetic marker, HLA-A2, and have developed resistance to certain immune therapies. The medication is designed to stimulate the immune system to recognize and attack cancer cells, potentially improving survival rates. It is classified as an immunotherapy agent, focusing on enhancing the body's natural defenses against cancer.

  • Docetaxel

    Docetaxel is given as an intravenous infusion and is a well-established chemotherapy drug used in the treatment of various cancers, including metastatic Non-Small Cell Lung Cancer (NSCLC). It works by interfering with the growth and division of cancer cells, ultimately leading to their death. Docetaxel is classified as a taxane, a type of chemotherapy that targets rapidly dividing cells, and is widely documented in medical literature for its role in cancer treatment.

Investigated diseases

Non-Small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of cases. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. As it progresses, patients may experience symptoms like persistent cough, chest pain, and difficulty breathing. The progression of the disease can vary, with some tumors growing slowly and others more rapidly. It is often diagnosed at an advanced stage when it has already metastasized to other organs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509340-10-00Protocol codeOSE2101C302Estimated enrolment409 patientsSponsorOSE Immunotherapeutics

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