Largest-ever Canadian clinical trial tests “poop pills” to improve immunotherapy for lung cancer

Pictured above Drs. Raphael, Maleki, and Silverman the FMT researchers supporting the BR39 LUNA-2 clinical trial

For nearly half of people diagnosed with lung cancer, immunotherapy can slow the disease but not stop it. Funded through a $4 million joint investment from the Canadian Cancer Society (CCS) and the Weston Family Foundation, a new clinical trial aims to change that. 

“For people with lung cancer that isn’t responding to standard treatments, time matters. LUNA-2 represents what’s possible when philanthropic partners, researchers and patients come together to test bold ideas — and bring hope for longer, better lives,” says Dr Stuart Edmonds, Executive Vice President, Mission, Research and Advocacy at CCS.

By testing new strategies to prevent, detect, treat and care for people affected by cancer, clinical trials are essential to driving research progress that can save and improve lives. The CCTG BR39 LUNA-2 trial will pair immunotherapy with fecal microbiota transplantation (FMT) with the goal of safely increasing treatment effectiveness. If successful, it could provide new treatment options for people with lung cancer, helping them live longer and with fewer side effects.

“With LUNA-2, we’re testing a carefully designed, made-in-Canada approach to improve how the immune system responds to treatment by harnessing the gut microbiome. This trial is about translating promising science into a practical option that could meaningfully improve outcomes and quality of life for people with lung cancer,” says Dr Saman Maleki, Scientist at London Health Sciences Centre Research Institute (LHSCRI).

Lung cancer is the most commonly diagnosed cancer in Canada and the leading cause of cancer death. Currently, only about 27% of people survive longer than 5 years after diagnosis. Although immunotherapy is an important part of lung cancer treatment, it doesn’t work for everyone. For these people, enhancing the effectiveness of immunotherapy could have a profound and life-saving impact.

Conducted by the Canadian Cancer Trials Group (CCTG) and led by researchers at LHSCRI and Lawson Research Institute of St. Joseph’s Health Care London (Lawson), this new clinical trial will be the largest-ever of its kind in Canada. The trial will test FMT – delivered through capsules, or “poop pills,” containing carefully screened gut microbes from healthy donors – alongside standard chemotherapy and immunotherapy to boost their effectiveness. In studies for other cancers this approach has shown great promise in improving treatment success and reducing side effects.

“The BR39 LUNA-2 clinical trial has been developed entirely in Canada, complete from the FMT product generation in London, Ontario to the conduct of the trial all across Canada. It is expected to generate unprecedented insight into how modifying the microbiome can enhance anti-tumour immunity, mitigate toxicity, and ultimately improve outcomes for lung cancer patients,” says Dr Pierre-Olivier Gaudreau, CCTG Senior Investigator.

The made-in-Canada phase II clinical trial will enroll 160 people with non-small cell lung cancer. Experts from Lawson will produce the capsules, and experts from LHSCRI will oversee patient care. Success with the LUNA-2 trial would open the door to larger studies and could change the way future treatments are designed.

“This clinical trial represents a leap forward in using FMT to create new pathways of personalized medicine. We have developed a world-first formulation of FMT, specific to cancer immunotherapy - a unique approach to care and a Canadian innovation that puts patients at the vanguard of medical discovery,” says Dr Michael Silverman, Scientist at Lawson of St. Joseph’s Health Care London.

This is the second time CCS and the Weston Family Foundation have teamed up to support a major FMT clinical trial. Last year, CCS launched the Pan-Canadian Lung Cancer Action Plan, which aims to reduce lung cancer mortality in Canada by 30% by 2035. By increasing funding for lung cancer research, this investment delivers on a key priority of the plan. It also builds on the Weston Family Foundation’s 9-year history of supporting Canadian researchers leveraging the microbiome to improve outcomes for people facing cancer.

Christian Bauta, Chair of the Weston Family Foundation concludes, “Funding cancer clinical trials isn’t just an investment in research, it’s an investment in time, hope and better outcomes for Canadians. By advancing microbiome science through clinical trials and partnering with the right national organizations, we can unlock new pathways for prevention and treatment, accelerating discovery and ensuring breakthroughs reach those who need them most.”

The BR39 LUNA-2 trial is expected to open to patient accrual in late 2026.