Actively Recruiting
Fiber-Boost Randomized Controlled Trial
Led by Cantonal Hospital of St. Gallen · Updated on 2026-03-19
42
Participants Needed
4
Research Sites
116 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In the present study 'Fiber-Boost', we investigate how a high-fiber diet affects the immunotherapy of advanced lung cancer and what effects it has on the gut microbiome (i.e., the bacteria in the gut) as well as the immune system. Study participants will be assigned to either a test group or a control group. Only patients in the test group will undergo a high-fiber diet. The study lasts 6 weeks per patient and will be conducted at 4 centers within Switzerland. A total of 42 patients are planned to be included in the study.
CONDITIONS
Official Title
Fiber-Boost Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Written informed consent according to Swiss law and ICH/GCP regulations
- Histologically or cytologically confirmed NSCLC
- Advanced or recurrent NSCLC not suitable for curative treatment
- PD-L1 expression 50% or higher by approved immunohistochemistry test
- No actionable genetic mutations in EGFR, ALK, ROS1, HER2, BRAF, RET, MET, NTRK genes
- Receiving first-line palliative PD-1/PD-L1-targeted monotherapy every 3 weeks
- Willing and able to participate in study interventions
- ECOG performance status between 0 and 2
- Adequate organ function including hemoglobin ≥70 g/L, platelet count ≥50 G/L, granulocytes ≥1 G/L
- Bilirubin, ALT, AST levels up to 3 times the upper limit of normal
- Glomerular filtration rate ≥30 mL/min/1.73m²
- Measurable or evaluable disease per RECIST 1.1
- Patients with CNS metastases allowed if no corticosteroid therapy or clinical progression
- Women with child-bearing potential must use effective contraception, have negative pregnancy test, and agree to avoid pregnancy during and 3 months after treatment
- Men who are not sterile must use condoms or abstain from sex during treatment and 3 months after
You will not qualify if you...
- History of malignancy within 3 years except certain low-risk cancers
- Prior adjuvant or additional systemic immune checkpoint blockade within 6 months
- Systemic antibiotic treatment within 10 days before starting immunotherapy or diet intervention
- Use of immunosuppressive drugs including corticosteroids ≥10 mg prednisone equivalent daily, methotrexate, azathioprine, TNF-alpha inhibitors
- Concurrent treatment with other experimental or anticancer therapies
- Major surgery within 14 days before inclusion
- Active autoimmune disease requiring systemic immunosuppression contraindicating PD-1/PD-L1 antibodies
- Uncontrolled diabetes mellitus
- Severe or uncontrolled cardiovascular disease
- Any serious medical, psychiatric, psychological, familial, or geographic condition affecting compliance or safety
- History of allogeneic tissue or solid organ transplant
- Current use of OptiFibre® or other fiber supplements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Universitätsspital Basel
Basel, Switzerland, 4031
Not Yet Recruiting
2
Kantonsspital Graubünden
Chur, Switzerland, 7000
Not Yet Recruiting
3
HOCH Health Ostschweiz, Cantonal Hospital St.Gallen
Sankt Gallen, Switzerland, 9007
Actively Recruiting
4
Kantonsspital Winterthur
Winterthur, Switzerland, 8401
Not Yet Recruiting
Research Team
M
Maximilian Boesch, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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