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NCT05008861
Gut Microbiota Reconstruction for NSCLC Immunotherapy
Phase 1 trial testing Capsulized Fecal Microbiota Transplant in Non-Small Cell Lung Cancer in 20 participants. Status unknown.
30 December 2022
Quick facts
| Lead sponsor | Shanghai Zhongshan Hospital |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 September 2021 |
| Primary completion | 30 December 2022 |
| Estimated completion | 30 December 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- Capsulized Fecal Microbiota Transplant
- Anti-programmed cell death protein 1/programmed death-ligand 1 monoclonal antibody — full drug profile →
- Platinum based chemotherapy
Conditions studied
- Non-Small Cell Lung Cancer — all drugs for Non-Small Cell Lung Cancer →
Sponsor
Shanghai Zhongshan Hospital
Who can join
Adults 18 to 75, any sex, with Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In this study, patients with locally advanced or metastatic NSCLC after first-line treatment with PD-1/PDL-1 monoclonal antibody will be treated with Gut Microbiota reconstruction(such as FMT) combined with PD-1/PDL-1 monoclonal antibody. We will evaluate the safety of FMT in the treatment of advanced NSCLC, and analyze the effect of FMT on intestinal flora and immunophenotype of patients.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Role of gut microbiome in cancer immunotherapy: from predictive biomarker to therapeutic target.
Zhang M, Liu J, Xia Q. · · 2023 · cited 77× · PMID 37770953 · DOI 10.1186/s40164-023-00442-x -
Modulating gut microbiome in cancer immunotherapy: Harnessing microbes to enhance treatment efficacy.
Kang X, Lau HC, Yu J. · · 2024 · cited 65× · PMID 38631285 · DOI 10.1016/j.xcrm.2024.101478 -
Antitumor effects of fecal microbiota transplantation: Implications for microbiome modulation in cancer treatment.
Xu H, Cao C, Ren Y, Weng S, et al · · 2022 · cited 63× · PMID 36177041 · DOI 10.3389/fimmu.2022.949490 -
From chaos to order: optimizing fecal microbiota transplantation for enhanced immune checkpoint inhibitors efficacy.
Lin A, Jiang A, Huang L, Li Y, et al · · 2025 · cited 45× · PMID 39826104 · DOI 10.1080/19490976.2025.2452277 -
Fecal microbiota transplantation: no longer cinderella in tumour immunotherapy.
Yang Y, An Y, Dong Y, Chu Q, et al · · 2024 · cited 43× · PMID 38241975 · DOI 10.1016/j.ebiom.2024.104967 -
Gut microbiota shapes cancer immunotherapy responses.
Lei W, Zhou K, Lei Y, Li Q, et al · · 2025 · cited 33× · PMID 40715107 · DOI 10.1038/s41522-025-00786-8 -
The Role of the Gut Microbiome in Cancer Immunotherapy: Current Knowledge and Future Directions.
Kiousi DE, Kouroutzidou AZ, Neanidis K, Karavanis E, et al · · 2023 · cited 29× · PMID 37046762 · DOI 10.3390/cancers15072101 -
Microbiome influencers of checkpoint blockade-associated toxicity.
Wang Y, Jenq RR, Wargo JA, Watowich SS. · · 2023 · cited 26× · PMID 36622383 · DOI 10.1084/jem.20220948
Verify or expand the search:
- PubMed search for NCT05008861
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Shanghai Zhongshan Hospital trials
Trials by the same sponsor.
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- NCT07508956 — Feasibility of Circulating Tumor DNA Based Minimal Residual Disease-Guided Adjuvant Therapy in Locally Advanced Gastric · Phase 3 · not yet recruiting
- NCT07535632 — SBRT Followed by PD-1 Inhibitor, Bevacizumab and TAS-102 as Third-Line Therapy for Recurrent/Metastatic Colorectal Cance · Phase 2 · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05008861 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Zhongshan Hospital
- Last refreshed: 17 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05008861.
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