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Study of EXL-01 and Nivolumab for Patients with Advanced Non-Small Cell Lung Cancer Resistant to Immunotherapy

Verified siteRegistered 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 Non-Small-Cell Lung Cancer (NSCLC), which is advanced and cannot be treated with surgery. The study is testing a combination of two treatments: EXL01, a capsule taken by mouth, and nivolumab, also known by its code name BMS936558, which is given through an infusion into a vein. The purpose of the study is to see how effective this combination is in helping patients live longer without their cancer getting worse.

Participants in the study will receive either the combination of EXL01 and nivolumab or a placebo. The study will last for several months, during which time participants will have regular check-ups to monitor their health and the progress of their cancer. The main goal is to see how many patients are alive and have not experienced cancer progression after three months. The study will also look at other factors, such as the overall response to the treatment and any side effects that may occur.

This trial is important for understanding how well the combination of EXL01 and nivolumab works for patients with advanced NSCLC who have not responded to previous treatments. By participating, researchers hope to gather valuable information that could lead to better treatment options for this type of lung cancer in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    Blood tests and imaging studies may be performed to ensure the patient meets all necessary criteria for participation.

  2. Step 2

    Treatment initiation

    The treatment involves a combination of two medications: nivolumab and EXL01.

    Nivolumab is administered as an intravenous infusion. The dosage and frequency are determined by the study protocol.

    EXL01 is taken orally in capsule form. The dosage and frequency are specified in the study guidelines.

  3. Step 3

    Treatment monitoring

    Regular monitoring is conducted to assess the patient's response to the treatment. This includes scheduled visits for physical examinations and laboratory tests.

    Imaging studies may be repeated to evaluate the progression of the disease.

  4. Step 4

    Progress evaluation

    The primary goal is to assess the progression-free survival at 3 months. This means evaluating whether the disease has not progressed and the patient is still alive.

    Secondary evaluations include overall response rate, overall survival, and disease control rate.

  5. Step 5

    Adverse event monitoring

    The study monitors for any adverse events related to the treatment. This includes tracking the frequency, type, and severity of any side effects.

    Particular attention is given to any severe adverse events occurring within the first 6 weeks of treatment.

  6. Step 6

    Follow-up

    After completing the treatment phase, follow-up visits are scheduled to continue monitoring the patient's health and any long-term effects of the treatment.

    The follow-up period extends until the end of the study or as specified in the study protocol.

Who can join the trial?

14 criteria

  • Patients must be **18 years or older**.
  • Must provide a **written consent** before any study procedures begin.
  • Must be **affiliated with social security** for standard care.
  • **Women** must not be pregnant or breastfeeding and must use a **highly effective contraceptive method** or be abstinent during the study and for 7 months after the last dose of the study drug.
  • **Men** must use a **highly effective contraceptive method** or be abstinent during the study and for 7 months after the last dose of the study drug.
  • Women must have a **negative pregnancy test** within 24 hours before receiving the study drug.
  • Must have an **ECOG Performance status** of 0-1, which is a scale used to assess how a disease affects a patient's daily living abilities.
  • Must have **advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC)** that cannot be operated on.
  • Must not have certain genetic changes in the cancer, such as **EGFR, ALK, ROS1, MET, HER2, RET, or BRAF**. However, **KRAS mutations** are allowed.
  • Must have previously received **anti-PD(L)1 therapy** and **platinum-based chemotherapy**.
  • Must have experienced cancer progression within **6 months** after starting anti-PD(L)1 therapy.
  • Must have received all available **standard treatments**.
  • Must have a **measurable disease** according to specific criteria.
  • Must have **adequate blood, kidney, and liver function** within 72 hours before the first dose of the study treatment.

Who cannot join the trial?

13 criteria

  • Patients who have a different type of cancer other than **Non-Small-Cell Lung Cancer (NSCLC)**. NSCLC is a type of lung cancer that is not small cell lung cancer.
  • Patients who have had surgery to remove their lung cancer. **Inoperable** means the cancer cannot be removed by surgery.
  • Patients who are under 18 years old.
  • Patients who are not able to understand or follow the study procedures.
  • Patients who are pregnant or breastfeeding.
  • Patients who have another serious illness that could interfere with the study.
  • Patients who have had another cancer in the past, unless it was treated and has not come back for a long time.
  • Patients who are taking certain medications that could interfere with the study treatment.
  • Patients who have had an organ transplant.
  • Patients who have an active infection that needs treatment.
  • Patients who have a history of severe allergic reactions.
  • Patients who have a condition that affects their immune system.
  • Patients who have participated in another clinical trial recently.
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Investigated drugs

  • EXL-01

    is an investigational medication being studied for its potential to help treat advanced non-small cell lung cancer (NSCLC) that has not responded to previous immunotherapy treatments. It is being tested in combination with another medication to see if it can improve outcomes for patients.

  • Nivolumab

    is a medication that helps the immune system fight cancer. It is used in this trial to see if it can work together with EXL-01 to improve the condition of patients with advanced NSCLC who have not had success with other immunotherapy options.

What is already known about the treatment

EXL-01 – This medication is administered intravenously and is currently being studied in combination with nivolumab for treating advanced non-small-cell lung cancer (NSCLC) that is resistant to previous immunotherapy. It is in the clinical trial phase, and its effectiveness is being evaluated in terms of progression-free survival. EXL-01 is designed to work at the molecular level by targeting specific pathways involved in cancer cell growth, although its exact mechanism of action is still under investigation. It falls under the pharmacological classification of experimental cancer therapies.

Investigated diseases

Non-Small-Cell Lung Cancer (NSCLC) – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is characterized by the uncontrolled growth of cells in the lung tissues, which can form tumors. NSCLC is known for its slower growth compared to small cell lung cancer, and it often spreads to other parts of the body. The disease is typically diagnosed at an advanced stage when it becomes inoperable or metastatic, meaning it has spread beyond the lungs. Symptoms may include persistent cough, chest pain, and difficulty breathing. The progression of NSCLC can vary, with some patients experiencing a gradual worsening of symptoms over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-505285-28-01Protocol codeDRI_2022/0641Estimated enrolment21 patientsSponsorCentre Hospitalier Universitaire De Lille

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