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Study of MIDRIX-LUNG immunotherapy combined with anti-PD-1 treatment in patients with metastatic non-small-cell lung cancer

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 studies the safety of combining an experimental treatment called MIDRIX-LUNG with immune therapy in people who have metastatic non-small-cell lung cancer. The experimental treatment uses special immune cells called dendritic cells that are collected from the patient's own blood and modified in a laboratory. These modified cells are then given back to the patient along with medications called pembrolizumab or cemiplimab, which help the immune system fight cancer.

The study also uses standard cancer treatments including chemotherapy drugs such as carboplatin, cisplatin, paclitaxel, and pemetrexed. Different combinations of these medications will be used depending on the specific type of lung cancer and previous treatments. The treatment involves receiving the modified immune cells through an intravenous infusion, along with the other medications.

The main purpose is to determine if this combination treatment is safe and to see how well patients tolerate it. The study will also look at whether the treatment helps control the cancer and how it affects quality of life. Patients will be monitored for side effects and will have regular scans to check how their cancer responds to the treatment. Blood tests will be done to measure how the immune system reacts to the treatment.

The research process

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

Step 1
Initial treatment phase
You will receive treatment based on your specific type of non-small-cell lung cancer (squamous or non-squamous) and previous treatments
Treatment will be administered through intravenous infusion (delivery of medication directly into your vein)
The medications may include combinations of: pembrolizumab or cemiplimab alone, or combined with carboplatin-paclitaxel or cisplatin-pemetrexed
Step 2
Cell collection procedure (leukapheresis)
A procedure called leukapheresis will be performed to collect specific cells from your blood
This procedure requires adequate vein access and passing several blood tests
The collected cells will be used to create your personalized treatment (MIDRIX-LUNG)
Step 3
Vaccination phase
You will receive multiple rounds of vaccination with the prepared dendritic cells
At least 3 vaccination rounds are planned if sufficient cells can be produced
Blood samples will be collected after each vaccination to monitor your immune response
Step 4
Monitoring and assessment
Regular evaluations will track your response to treatment using imaging scans
Side effects will be monitored and recorded using standardized criteria
Quality of life assessments will be conducted using specific questionnaires
Monitoring will continue for three months after your last vaccine dose

Who can join the trial?

17 criteria

Patient must be at least 18 years old
Patient must provide written informed consent before screening
Patient must have confirmed lung cancer (NSCLC) that has spread to other parts of the body (metastatic) or is locally advanced
Patient must have at least one measurable tumor that can be evaluated during screening
Patient must have good physical function (ECOG score 0-1, meaning able to carry out light daily activities)
Patient's expected survival must be more than 12 weeks
If patient has brain metastases (cancer spread to brain), they must be either showing no symptoms or stable after radiation treatment
Patient must have adequate organ function including:
- Good bone marrow function (adequate blood cell counts)
- Good kidney function
- Good liver function
- For female patients who can become pregnant:
  - Must have negative pregnancy test
  - Must agree to use birth control during the study
  - For male patients with partners who can become pregnant:
    
    Must agree to use birth control during study and for 90 days after
    Should have completed sperm banking if desired before treatment
    Patient must meet specific requirements for blood collection procedure (leukapheresis), including:
    
    Good vein access
    Normal blood clotting
    Negative tests for certain viruses and infections

Who cannot join the trial?

15 criteria

Age below 18 years or above 65 years
Pregnant or breastfeeding women
Active or untreated brain metastases (cancer that has spread to the brain)
History of autoimmune disease requiring systemic treatment
Active or chronic infection with hepatitis B or hepatitis C
Active tuberculosis infection
Previous treatment with cancer immunotherapy in the last 4 weeks
Major surgery within 4 weeks before starting the study
Serious heart conditions, including heart failure or uncontrolled high blood pressure
Severe kidney or liver dysfunction
Known allergy or sensitivity to study medications
Participation in another clinical trial within 30 days
Any condition that, in the opinion of the study doctor, would make participation unsafe
Unable to provide informed consent
History of other cancers within the past 3 years, except for successfully treated non-melanoma skin cancer

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Verified sites

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Universitair Ziekenhuis Gent
Responsive
Gent, Belgium

Trial locations

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Investigated drugs

MIDRIX-LUNG-00x
is an experimental autologous dendritic cell immunotherapy. This means it's made from the patient's own immune cells, which are modified in a laboratory to help fight cancer. The therapy aims to strengthen the body's natural ability to detect and fight lung cancer cells.
Anti-PD-1 therapy
is a type of immunotherapy that helps the immune system recognize and attack cancer cells. It works by blocking a protein called PD-1, which normally prevents T-cells (immune cells) from attacking other cells in the body. By blocking PD-1, this therapy allows the immune system to better identify and destroy cancer cells.

What is already known about the treatment

MIDRIX-LUNG-00x
An experimental autologous dendritic cell immunotherapy being studied in clinical trials for the treatment of metastatic non-small-cell lung cancer (NSCLC). This personalized treatment involves collecting a patient's own immune cells (dendritic cells), modifying them in a laboratory, and then administering them back to the patient to enhance the immune response against cancer cells. The therapy is being tested in combination with anti-PD-1 treatment, which helps the immune system recognize and attack cancer cells more effectively. Currently in Phase 1b clinical trials, this investigational therapy represents a novel approach in immunotherapy for lung cancer treatment, focusing on safety assessment and potential therapeutic benefits.
Anti-PD-1 therapy
A type of immunotherapy medication administered intravenously that works by blocking the PD-1 protein on immune cells, which normally acts as a brake on the immune system. By blocking this protein, the therapy allows the body's immune system to better recognize and attack cancer cells, particularly in cases of metastatic non-small-cell lung cancer. This established class of drugs has shown significant success in cancer treatment and is currently approved for clinical use, with ongoing studies exploring its effectiveness in combination with other therapies. The treatment typically requires regular infusions at specified intervals under medical supervision.

Investigated diseases

Non-small-cell lung cancer (NSCLC) - A type of lung cancer that begins in the cells of the lungs and can spread to other parts of the body. It develops when healthy cells in the lung tissue begin to grow uncontrollably and form masses called tumors. When these cancer cells spread from their original location to other parts of the body, it is called metastatic NSCLC. The disease typically develops slowly and may not cause noticeable symptoms in its early stages. NSCLC accounts for the majority of all lung cancer cases and includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.