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Non-Small Cell Lung CancerPhase 1NCT05008861

Gut Microbiota Reconstruction for NSCLC Immunotherapy

A Phase 1 study testing Capsulized Fecal Microbiota Transplant, Anti-programmed cell death protein 1/programmed death-ligand 1 monoclonal antibody and Platinum based chemotherapy in people with Non-Small Cell Lung Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Capsulized Fecal Microbiota Transplant, Anti-programmed cell death protein 1/programmed death-ligand 1 monoclonal antibody and Platinum based chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Sep 2021to 30 Dec 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.Volunteer to participate in this trial, fully understand this trial, and sign the Informed Consent Form (ICF).
  • 2.18-75 years old on the day of signing the ICF. 3.Locally advanced/metastatic non-small cell lung cancer diagnosed by histology or cytology. no epidermal growth factor receptor (EGFR) sensitive mutations, anaplastic lymphoma kinase (ALK) gene rearrangement, ROS Proto-oncogene 1 (ROS1) gene fusion.
  • 4.Have stable disease (SD) defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after receive at least 2 doses of anti-PD-1/PD-L1 for first-line treatment.
  • 5.Have not received systemic treatment for locally advanced/metastatic NSCLC before immunotherapy.
  • 6.Have measurable target lesions judged by the investigator according to Response Evaluation Criteria In Solid Tumors (RECIST V1.1).
  • 7.0~1 ECOG score. 8.Life expectancy ≥ 12 weeks. 9.Have sufficient organ function, evaluated based on blood routine, renal function, liver function, and coagulation laboratory test results (and have not received blood transfusion or infusion of apheresis components within 14 days before the study drug administration , Erythropoietin, granulocyte colony stimulating factor and other medical support treatments).
  • 10.Women of Childbearing Potential (WOBCP) must undergo a serum pregnancy test within 7 days before the first medication, and the result is negative; WOBCP or men and their WOBCP partners should agree from signing the ICF to the last one. Take effective contraceptive measures within 6 months after taking the study drug.

Who cannot join

  • Before the first administration of the anti-PD-1/PD-L1 reatment: a) have received previous systemic cytotoxic chemotherapy for metastatic disease; b) have received other targeted or biological anti-tumor therapy for metastatic disease ; c) received major surgery (<3 weeks before the first dose); d) received lung radiotherapy >30 Gy within 6 months before the first dose of the trial treatment; e) the first trial treatment Palliative radiotherapy was completed within 7 days before administration.
  • Any other form of anti-tumor therapy is expected during the study period.
  • Have progressive disease (PD) or response(CR or PR) defined by RECIST v1.1 after receive at least 2 doses of anti-PD-1/PD-L1 for first-line treatment.
  • Unable to tolerate anti-PD-1/PD-L1 treatment due to adverse events or other reasons.
  • Unable to swallow FMT capsules.
  • Received antibiotic treatment within 30 days before the planned FMT started.
Show all 19Show fewer
  • Fecal occult blood test or calprotectin positive; have ulcerative colitis, Crohn's disease, ischemic enteritis, infectious enteritis, etc not suitable to take intestinal bacteria capsules, but not include anti-PD-1/PD-L1-related colitis.
  • Live virus vaccines have been vaccinated within 30 days before the planned treatment. Seasonal influenza vaccine without live virus is allowed.
  • A history of past malignant disease is known, unless the subject receives potentially curative treatment and there is no evidence of disease recurrence within 5 years after starting treatment.
  • Accompanying known active central nervous system (CNS) metastasis and/or cancerous meningitis.
  • According to the standard of Common Adverse Event Terminology (CTCAE) 4th edition, peripheral neuropathy has been ≥2 grade.
  • Severe hypersensitivity reactions to other monoclonal antibody treatments have occurred in the past.
  • Accompanied by active autoimmune diseases, systemic treatment (ie, use of disease modifiers, corticosteroids or immunosuppressive drugs) is required within the past 2 years.
  • Are receiving long-term systemic steroid therapy. Subjects with asthma who require intermittent use of bronchodilators, inhaled steroids, or topical steroid injections are not excluded.
  • Have received any other anti-PD-1 or PD-L1 or PD-L2 drugs or antibodies in the past, or small molecule therapy that targets other immunomodulatory receptors or mechanisms. Participated in any other anti-PD-1/PD-L1 trials and received anti-PD-1/PD-L1 treatment. Such antibodies include (but are not limited to) antibodies against IDO, PD-L1, IL-2R and GITR.
  • Active infections requiring treatment.
  • Known human immunodeficiency virus (HIV) history (known HIV1/2 antibody positive). Accompanied by known active hepatitis B or C.
  • Being pregnant or breastfeeding, or expecting to conceive or conceive during the period of study drug treatment and within the required contraceptive period after the last administration of the study drug.
  • The researcher believes that there are any circumstances that are not suitable for selection.

Trial locations and contacts

1 site in 1 country.

Qi Chen, MD contact

86-17811921405

chenqimd@163.com

China1 site

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: Safety of Gut Microbiota Reconstruction Plus PD-1/PD-L1 Monoclonal Antibodies to Treat Locally Advanced or Metastatic Non-Small Cell Lung Cancer

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.

Being tested
Capsulized Fecal Microbiota Transplant, Anti-programmed cell death protein 1/programmed death-ligand 1 monoclonal antibody, Platinum based chemotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Capsulized Fecal Microbiota TransplantProcedure or surgery

    Also called Capsulized FMT

    Capsules contained washed fecal microbiota.

  • Anti-programmed cell death protein 1/programmed death-ligand 1 monoclonal antibodyDrug

    Also called Anti-PD-1/PD-L1 mAb, Anti-PD-1/PD-L1, Pembrolizumab, Nivolumab

    Standard dose of one of anti-PD-1/PD-L1 mAbs administered as a 1 hour infusion every 3 weeks.

  • Platinum based chemotherapyDrug

    Also called Platinum based Chemotherapy drugs

    Standard dose of Platinum based Chemotherapy every 3 weeks.

Study groups in NCT05008861
Study groupRoleWhat they receive
FMT with anti-PD-1/PD-L1 treatmentExperimentalNot described
Receives: Procedure: Capsulized Fecal Microbiota Transplant; Drug: Anti-programmed cell death protein 1/programmed death-ligand 1 monoclonal antibody; Drug: Platinum based chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of FMT-related Adverse Events

    Number of patients with adverse events after FMT

    Measured: 2 years

  2. Incidence of anti-PD-1/PD-L1-related Adverse Events

    Number of patients with adverse events related to anti-PD-1/PD-L1 after FMT

    Measured: 2 years

Secondary outcomes (5)

  1. Changes in diversity and composition of gut microbiota

    Compare the difference of gut microbiota diversity and composition between pre-FMT and post-FMT samples. Microbiota diversity will be quantified by α-diversity ( Faith's Phylogenetic Diversity) based on meta-genomics sequencing. Microbiota composition will be quantified by the operational taxonomic unit (OTU) in the stool.

    Measured: 2 years

  2. Efficiency of FMT engraftment

    Evaluate the acquired similarity of the recipient microbiota to the donor microbiota by measuring the Euclidian distance between donor microbial composition and every available time point of the corresponding recipients, starting from the pre-FMT sample.

    Measured: 2 years

  3. Changes in concentration of peripheral blood mononuclear cells

    Compare composition and content of peripheral blood mononuclear cells (CD8+T-cells, NK cells and myelin-sourced inhibitory cells) between pre-FMT and post-FMT samples. The composition and content of CD8+T-cells, NK cells and myelin-sourced inhibitory cells were analyzed by flow cytometry.

    Measured: 2 years

  4. Changes in concentration of tumor immune related cytokines

    Compare the contents of tumor immune related cytokines (IFNγ、TNF、Granzyme A/B、Perforin and et al) between pre-FMT and post-FMT samples. The contents of tumor immune related cytokines were analyzed by enzyme-linked immunosorbent assay.

    Measured: 2 years

  5. Objective response rate (ORR)

    Number of patients with objective responses divided by the total number of evaluable patients, according to imaging studies (RECIST 1.1) and iRECIST

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2021
  2. Study start1 Sep 2021 (estimated)
  3. Primary completion30 Dec 2022 (estimated)
  4. Study completion30 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05008861
Sponsor's protocol ID
B2021-179R
Status last verified
Aug 2021
First submitted
12 Aug 2021
Last updated
17 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available from the principal investigator Taotao Liu at shen.xizhong@zs-hospital.sh.cn, beginning 6 months and ending 5 years after the trial results were published. The study protocol and statistical analysis plan are available online from https://clinicaltrials.gov/. All proposals requesting data access will need to specify how it is planned to use the data, and all proposals will need approval of all investigators before data release.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Capsulized Fecal Microbiota Transplant, Anti-programmed cell death protein 1/programmed death-ligand 1 monoclonal antibody and Platinum based chemotherapy in people with Non-Small Cell Lung Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Qi Chen, MD (86-17811921405, chenqimd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of FMT-related Adverse Events (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05008861.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.

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