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临床试验 NCT07483112 (Fiber-Boost) 针对Non-Small Cell Carcinoma of Lung目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Fiber-Boost Randomized Controlled Trial 42 免疫疗法 微生物组 随机化 饮食
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临床试验NCT07483112 (Fiber-Boost)是一项针对Non-Small Cell Carcinoma of Lung的干预性研究试验，目前试验状态为招募中。试验始于2025年10月7日，计划招募42名患者。该研究由Cantonal Hospital of St. Gallen主导，预计于2027年12月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月19日。
简要概括
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 b...显示更多
详细描述
The activity of immune checkpoint blockade (ICB) mechanistically depends on the host microbiome and is manipulable through diet. In this study termed Fiber-Boost, we propose a multicenter trial of a supplement-based high-fiber diet (HFD) in non-small cell lung cancer (NSCLC) treated with first-line ICB monotherapy. Using a randomized, controlled design, we mechanistically explore the role of dietary fibers in cancer ...显示更多
官方标题
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)
疾病
Non-Small Cell Carcinoma of Lung其他研究标识符
- Fiber-Boost
- BASEC2025-00650
- KFS-6039-02-2024 (其他拨款/资助编号) (Krebsforschung Schweiz)
- Lungenliga Ost (其他拨款/资助编号) (Lungenliga Ost)
- Swiss Cancer Foundation (其他拨款/资助编号) (Swiss Cancer Foundation)
- Nestlé Health Science (其他拨款/资助编号) (Nestlé Health Science)
NCT编号
实际开始日期
2025-10-07
最近更新发布
2026-03-19
预计完成日期
2027-12-31
计划入组人数
42
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
non-small cell lung cancer
immunotherapy
high-fiber diet
microbiome
immunotherapy
high-fiber diet
microbiome
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性High-fiber diet Patients in this arm will receive a high-fiber diet over the period of 6 weeks. | High-fiber diet Patients in the intervention arm will receive a high-fiber diet through daily consumption of a defined amount of plant-based fibers from a commercial product. |
无干预No high-fiber diet Patients in this arm will not receive an intervention and serve as control. | 不适用 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
ctDNA clearance | Fraction of patients achieving complete ctDNA clearance at 6 weeks | 6 weeks |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
ctDNA dynamics | ctDNA dynamics over 6 weeks | 3 and 6 weeks |
Radiological treatment response | Objective radiological response (RECIST 1.1) | 6 weeks and 6 months |
Disease control rate | 6-months disease control rate (non-progressive disease at 6 months) | 6 months |
Microbiota dynamics | Gut microbiota dynamics by shotgun metagenomics | 6 weeks |
Systemic immune response | Systemic immune response dynamics by high-dimensional flow cytometry | 6 months |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- 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/1.73m²
- 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.
-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-α 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
Cantonal Hospital of St. Gallen研究责任方
Maximilian Boesch, 主要研究者, Principal Investigator, Cantonal Hospital of St. Gallen
研究中心联系人
联系人: Maximilian Boesch, Ph.D., 0041714947143, [email protected]
4 位于 1 个国家/地区的研究中心
Universitätsspital Basel, Basel, 4031, Switzerland
Geraldine Borer, 联系人, 0041613287081, [email protected]
尚未招募
Kantonsspital Graubünden, Chur, 7000, Switzerland
Gabriela Manetsch-Dalla Torre, 联系人, 0041812566860, [email protected]
尚未招募
HOCH Health Ostschweiz, Cantonal Hospital St.Gallen, Sankt Gallen, 9007, Switzerland
Maximilian Boesch, Ph.D., 联系人, 0041714947143, [email protected]
招募中
Kantonsspital Winterthur, Winterthur, 8401, Switzerland
Beatrice Brinkers, 联系人, 0041522663655, [email protected]
尚未招募