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Safety and feasibility study of fecal microbiota transplant in stage II-III non-small cell lung cancer patients treated with durvalumab, carboplatin, paclitaxel and rifaximin

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Non-Small Cell Lung Cancer (NSCLC) in stages II-III. The research investigates the safety and effectiveness of fecal microbiota transplant (transfer of stool from one person to another) in combination with several medications. The main treatment includes durvalumab, which is given through an intravenous infusion and works by helping the immune system fight cancer cells.

The treatment plan combines different medications: rifaximin (taken as tablets by mouth), carboplatin, and paclitaxel (both given through intravenous infusion). The study aims to determine if adding stool transplants from patients who have previously responded well to cancer immunotherapy can improve treatment outcomes for new patients.

During the study, patients will receive treatment over several months. The treatment includes regular doses of medications and monitoring of how the cancer responds to therapy. The stool transplant procedure will be performed as part of the treatment process. Doctors will perform various tests and scans throughout the study to check how well the treatment is working and to monitor for any side effects.

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
Initial treatment phase
You will receive durvalumab through an intravenous infusion. This medication helps your immune system fight cancer cells.
You will also receive carboplatin and paclitaxel through intravenous infusions. These are cancer-fighting medications.
Additionally, you will take rifaximin tablets by mouth. This medication affects bacteria in your digestive system.
Step 2
Medical evaluations
Your doctor will perform regular examinations to check how your body responds to the treatment.
You will have CT scans to measure any changes in your lung cancer.
Your blood will be tested regularly to monitor your body's functions.
Step 3
Surgery phase
After the initial treatment, you will undergo surgery to remove the remaining cancer tissue.
The surgery results will be examined to determine if any cancer cells remain in your lungs or lymph nodes.
Step 4
Follow-up period
Your health will be monitored for up to 24 months after treatment.
Regular check-ups will track your recovery and any signs of cancer returning.
Side effects will be recorded and treated as needed.
Step 5
Safety requirements
If you can have children, you must use effective birth control during the study and for 6 months after the last treatment.
Regular pregnancy tests will be required for women who can become pregnant.
You will need to attend all scheduled appointments and follow the treatment plan as prescribed.

Who can join the trial?

14 criteria

Must be at least 18 years old
Must have previously untreated non-small cell lung cancer at stages IIA, IIB, IIIA, or IIIB
Must have no signs of cancer spread to distant parts of the body (confirmed by PET scan and brain CT or MRI)
Must be in good overall physical condition (ECOG score of 0-1, meaning able to perform daily activities)
Must have adequate blood test results showing good organ function
Must have good lung function test results
Must weigh more than 30 kg
Must have had PDL1 testing completed (a test that helps determine treatment options)
Must have at least one tumor that can be measured by CT scan
Must have a life expectancy of at least 12 weeks
Must be willing to follow study requirements and attend all scheduled visits
Must provide written informed consent to participate in the study
For women who can become pregnant: Must have a negative pregnancy test and use effective birth control during the study and for 6 months after
For men with partners who can become pregnant: Must use effective birth control including condoms during the study and for 6 months after

Who cannot join the trial?

15 criteria

Prior treatment with chemotherapy (medications used to kill cancer cells) for lung cancer
History of other cancers in the past 5 years, except for successfully treated skin cancer or cervical cancer
Serious heart conditions including heart failure (when heart cannot pump blood effectively) or recent heart attack within 6 months
Severe kidney or liver problems
Active or untreated brain metastases (cancer that has spread to the brain)
Current pregnancy or breastfeeding
Known allergies to study medications
Autoimmune diseases (conditions where immune system attacks healthy cells)
Active infections requiring treatment
Participation in other clinical trials within 30 days
Mental conditions that could interfere with following study procedures
Use of medications that could interact with study treatment
History of organ transplantation
Uncontrolled high blood pressure
Active bleeding problems or conditions requiring blood thinners

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Verified sites

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

Complexo Hospitalario Universitario De Vigo
Responsive
Vigo, Spain
Hospital Clinico San Carlos
Verified
Madrid, Spain
Hospital De La Santa Creu I Sant Pau
Verified
Barcelona, Spain

Trial locations

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Investigated drugs

Fecal Microbiota Transplant (FMT)
This is a procedure where fecal matter from a healthy donor is processed and transferred to a recipient. In this trial, the donors are patients who have responded well to immune checkpoint inhibitor therapy. The transplant aims to modify the gut microbiome of the recipient, which may influence how the body responds to cancer treatment.
Immune Checkpoint Inhibitors (ICI)
These are medications that help the immune system recognize and attack cancer cells. They work by blocking certain proteins that normally prevent the immune system from attacking cancer cells. In this trial, they are used in the treatment of non-small cell lung cancer, and patients who respond well to this therapy serve as donors for the fecal microbiota transplant.

What is already known about the treatment

Based on the provided trial data, this study involves Immune Checkpoint Inhibitors (ICI), so I'll provide a description for this class of medications: Immune Checkpoint Inhibitors (ICI) – A class of immunotherapy medications administered through intravenous infusion that helps the immune system recognize and attack cancer cells more effectively. These drugs work by blocking specific proteins that normally prevent T-cells from killing cancer cells, essentially releasing the "brakes" on the immune system's natural ability to fight cancer. They are primarily used in the treatment of various cancers, including non-small cell lung cancer (NSCLC), and have revolutionized cancer treatment in recent years by showing significant improvements in survival rates for some patients. ICIs belong to the biological therapy class of medications and are considered a cornerstone of modern cancer immunotherapy.

Investigated diseases

Non-Small Cell Lung Cancer - A type of lung cancer that begins in the cells of the lungs and forms as a mass of cancerous cells that grows larger over time. It develops when healthy cells in the lung tissue begin to change and grow uncontrollably, forming a tumor. The cancer typically starts in the cells that line the airways of the lungs (bronchi). This disease progresses gradually, spreading first within the lung itself and potentially to nearby lymph nodes. It is the most common form of lung cancer, accounting for about 85% of all lung cancers.