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

Switzerland (ICTRP)

ID di studio ICTRP
NCT07483112 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
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)

Titolo accademico
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)

Titolo pubblico
Fiber-Boost Randomized Controlled Trial (ICTRP)

Malattie studiate

Non-Small Cell Carcinoma of Lung

(ICTRP)

Intervento studiato

Dietary Supplement: High-fiber diet

(ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio

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

(ICTRP)

Criteri di inclusione/esclusione

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)

non disponibile

Endpoint primari e secondari

ctDNA clearance

(ICTRP)

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

(ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

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

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

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT07483112 (ICTRP)