Relevance of a High-Fiber Diet for Cancer Immunotherapy in Lung Cancer

Switzerland (ICTRP)

ICTRP Studien-ID
NCT07483112 (ICTRP)

Offizieller Titel (Genehmigt von der Ethikkommission)
Multicenter, Randomized, Controlled Trial to Study the Effects of a High-Fiber Dietary Intervention on ctDNA Clearance and the Microbial and Immunological Landscape in Patients with Advanced Non-Small Cell Lung Cancer Receiving PD-1/PD-L1-Targeted Monotherapy (Fiber-Boost) (BASEC)

Wissenschaftlicher Titel
Multicenter, Randomized, Controlled Trial to Study the Effects of a High-Fiber Dietary Intervention on ctDNA Clearance and the Microbial and Immunological Landscape in Patients With Advanced Non-Small Cell Lung Cancer Receiving PD-1/PD-L1-Targeted Monotherapy (Fiber-Boost) (ICTRP)

Öffentlicher Titel
Fiber-Boost Randomized Controlled Trial (ICTRP)

Untersuchte Krankheit(en)

Non-Small Cell Carcinoma of Lung

(ICTRP)

Untersuchte Intervention

Dietary Supplement: High-fiber diet

(ICTRP)

Studientyp
Interventional (ICTRP)

Studiendesign

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).

(ICTRP)

Ein-/Ausschlusskriterien

Inclusion Criteria:

• Age =18 years
• Written informed consent according to Swiss law and ICH/GCP regulations before inclusion and prior to any trial-specific procedures
• Histologically or cytologically confirmed NSCLC
• Advanced or recurrent NSCLC not amenable to curative treatment
• PD-L1 expression =50% (TPS) determined by an approved IHC test
• No actionable genetic alterations in genes such as EGFR, ALK, ROS1, HER2, BRAF, RET, MET, NTRK
• First-line palliative PD-1/PD-L1-targeted monotherapy at a 3-weekly schedule indicated per local investigator
• Willingness and ability to undergo study interventions
• ECOG performance status 0-2
• Adequate organ function:
• Hemoglobin =70 g/L, platelet count =50 G/L, granulocytes =1 G/L
• Bilirubin, ALT, AST =3 x ULN
• Glomerular filtration rate (Cockroft-Gault) =30 mL/min/1.73m
• Measurable or evaluable disease per RECIST 1.1
• Patients with CNS metastases are eligible, provided there is no requirement for corticosteroids as therapy for CNS disease and no evidence of clinical progression
• Women with child-bearing potential use effective contraception (two independent methods), are not currently pregnant or lactating, and agree to not become pregnant during the trial treatment and during 3 months thereafter. A negative pregnancy test in either urine or blood is required for women with child-bearing potential before trial inclusion.
• Men who are not sterile agree to use contraceptive methods (condoms) or abstain from sexual intercourse during the trial treatment and 3 months thereafter.

Exclusion Criteria:

• History of malignancy, unless in remission for at least 3 years before inclusion with the exception of pT1-2 prostate cancer Gleason score <6, adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer

Adjuvant or additive systemic ICB treatment within 6 months prior to inclusion

• Systemic treatment with an antibiotic within 10 days of ICB treatment/HFD intervention start
• Concomitant immunosuppressive drugs including corticosteroids at a daily dose of =10mg prednisone equivalents, methotrexate, azathioprine, TNF-a inhibitors
• Concurrent treatment with other experimental drugs or other anticancer therapy
• Major surgical procedures within 14 days prior to inclusion as judged by the investigator
• Active autoimmune disease requiring systemic immunosuppressive treatment that is seen as contraindication for the use of PD-1/PD-L1-targeted monoclonal antibodies
• Uncontrolled diabetes mellitus
• Severe or uncontrolled cardiovascular disease
• Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications
• Had an allogeneic tissue/solid organ transplant
• Ongoing supplementation with OptiFibre or another fiber supplement

(ICTRP)

nicht verfügbar

Primäre und sekundäre Endpunkte

ctDNA clearance

(ICTRP)

ctDNA dynamics;Radiological treatment response;Disease control rate;Microbiota dynamics;Systemic immune response

(ICTRP)

Registrierungsdatum
nicht verfügbar

Einschluss des ersten Teilnehmers
nicht verfügbar

Sekundäre Sponsoren
nicht verfügbar

Weitere Kontakte
Maximilian Boesch, Ph.D., maximilian.boesch@h-och.ch, 0041714947143 (ICTRP)

Sekundäre IDs
KFS-6039-02-2024, Lungenliga Ost, Swiss Cancer Foundation, Nestl� Health Science, BASEC2025-00650 (ICTRP)

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar

Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT07483112 (ICTRP)