Canadian Researchers Launch Largest FMT Trial to Enhance Lung Cancer Immunotherapy

Canadian researchers have launched the LUNA-2 trial, the largest fecal microbiota transplantation (FMT) cancer study ever conducted in Canada, testing whether "poop pills" can enhance immunotherapy effectiveness for lung cancer patients. The phase II clinical trial, backed by a $4 million joint investment from the Canadian Cancer Society and the Weston Family Foundation, will enroll 160 people with non-small cell lung cancer.

The study addresses a critical gap in lung cancer treatment, where immunotherapy can slow disease progression for nearly half of patients but fails to stop it entirely. With lung cancer being the most commonly diagnosed cancer in Canada and the leading cause of cancer death, only about 27% of people survive longer than 5 years after diagnosis.

Novel Microbiome-Based Approach

The LUNA-2 trial will test FMT delivered through capsules containing carefully screened gut microbes from healthy donors alongside standard chemotherapy and immunotherapy. According to Dr. Saman Maleki, scientist at London Health Sciences Centre Research Institute, "We're testing a carefully designed, made-in-Canada approach to improve how the immune system responds to treatment by harnessing the gut microbiome."

Dr. Michael Silverman, scientist at Lawson Research Institute, emphasized the innovation behind the approach: "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."

Comprehensive Canadian Collaboration

Conducted by the Canadian Cancer Trials Group (CCTG) and led by researchers at London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's Health Care London, the trial represents a fully Canadian-developed initiative. Experts from Lawson will produce the capsules, while experts from LHSCRI will oversee patient care.

The multidisciplinary research team includes thoracic medical oncologists, infectious disease specialists, microbiologists, and biostatisticians from institutions across Canada, including Western University, Queen's University, University of Toronto, and Princess Margaret Cancer Centre.

Building on Promising Preclinical Evidence

In studies for other cancers, the FMT approach has shown great promise in improving treatment success and reducing side effects. Dr. Pierre-Olivier Gaudreau, CCTG Senior Investigator, noted that the trial "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."

Strategic Investment in Cancer Research

This marks the second collaboration between the Canadian Cancer Society and Weston Family Foundation to support a major FMT clinical trial. The investment aligns with the Pan-Canadian Lung Cancer Action Plan launched last year, which aims to reduce lung cancer mortality in Canada by 30% by 2035.

Christian Bauta, Chair of the Weston Family Foundation, stated: "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."

Potential to Transform Treatment Paradigms

Success with the LUNA-2 trial could open doors to larger studies and fundamentally change how future lung cancer treatments are designed. Dr. Stuart Edmonds, Executive Vice President at the Canadian Cancer Society, emphasized the urgency: "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."

The trial builds on the Weston Family Foundation's 9-year history of supporting Canadian researchers leveraging the microbiome to improve outcomes for people facing cancer, potentially offering new treatment options that could help patients live longer with fewer side effects.