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

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What is this study about?

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.

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

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)

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

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Universitair Ziekenhuis Gent Gent Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
01.09.2025

Trial locations

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.

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.

Trial ID:
2025-521577-13-00
Protocol code:
DARE-LUNG
Trial Phase:
Human Pharmacology (Phase I) – First administration to humans

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