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A non-small cell lung cancer clinical trial - BR39

Comparing microbiome capsules combined with immunotherapy and chemotherapy to immunotherapy and chemotherapy alone for participants with advanced non-small cell lung cancer
Disease Site
Lung Clinical Trials
Trial Code
BR.39 (LUNA2) ǀ NCT07890493
Trial Status
Open to patient enrollment

What is the purpose of this study?

The purpose of this study is to compare the effects on you and your advanced non-small cell lung cancer of adding a new treatment called fecal microbiota transfer (FMT) to boost your response to immunotherapy. Researchers are comparing FMT with the standard treatment (immune checkpoint blockade (ICB) and chemotherapy) and the standard treatment alone.

Why is this study important?

The trial will test if FMT capsules boosts the effectiveness of standard chemotherapy and immunotherapy. This works by introducing new microbes into your gut. In other studies, this approach has shown great promise in improving treatment success and reducing side effects, but it is not clear if it can offer better results than standard treatment alone.

Who can participate in this study?

This trial is for:

  • People 18 years of age or older with non-small cell lung cancer that has spread from where it first started (advanced disease)
  • People that have not had ICB treatment for their advanced non-small cell lung cancer
  • People that can swallow medications

This trial is not for:

  • People with inflammatory bowel disease
  • People with severe food allergies, e.g. shellfish, nuts
  • People who have been treated with antibiotics in the last 14 days
  • People who take regular probiotics, antibiotics or corticosteroids
  • People with active viral infections, Hepatitis B or Hepatitis C, or any uncontrolled autoimmune disease
  • People that have received a live vaccines in the last 4 weeks, e.g. MMR, nasal spray flu vaccine, chicken pox (varicella)
  • People that are pregnant or breastfeeding and/or expecting to conceive children
What are the risks?
  • If you choose to take part in this study, there is a risk that the new treatment added to the current standard treatment may not be as good as the standard treatment alone. There is also a risk that you could have side effects from the new treatment. Some of the most common side effects that the study doctors know about are diarrhea, nausea, flatulence, and change in stool appearance. You will find details of all side effects in the consent document.
What can I expect?
  • If you choose to take part in this study, you will be randomly placed in one of two groups and you will receive either FMT with standard treatment (ICB + chemotherapy) or the standard treatment alone.
  • In this study, you will also be asked to complete a few questionnaire(s) at different times, to understand your Quality of Life.

How can I find out more or join the study?

Talk to your cancer doctor if you are considering joining this study. You can share summaries like this with them and ask if they think joining the trial may be a good option for you.

Before you join this study, you will be asked to review an Informed Consent document which will tell you more about why the research is being done and your role as a participant. You will have an opportunity to discuss anything that is not clear and ask any questions you have.

Joining this study is entirely up to you and you can decide to leave at any time without giving a reason. Your decision to join or leave the trial will not affect your standard medical care.

The BR.39 study is currently enrolling patients at cancer centres in Canada. For a full list of participating cancer centres please visit www.clinicaltrials.gov and search using NCT07890493.

Use this trial information for your conversation with your health care team

Participating centres

Information coming soon.