Non-Small Cell Lung CancerNCT04682327
Gut Microbiota and Cancer Immunotherapy Response
An observational study of Non-Small Cell Lung Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This study will analyze the composition and diversity of the gut microbiota of patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) through metagenomic high-throughput sequencing methods, and explore the relationship between the gut microbiota and anti-PD-1/PD-L1 treatment response. 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?
- Response to anti-PD-1/PD-L1 and Non-response to anti-PD-1/PD-L1
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2021to 30 Dec 2022
- Phase
- Observational
- 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
Study population: Patients with local late/metastasis non-small cell lung cancer treated with the first-line treatment of anti-PD-1/PD-L1 treatment
Who may be able to join
- Volunteer to participate in this trial, fully understand this trial, and sign the Informed Consent Form (ICF).
- 18-75 years old on the day of signing the ICF.
- 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.
- receive anti-PD-1/PD-L1 for first-line treatment.
- Have not received systemic treatment for locally advanced/metastatic NSCLC.
- Have measurable target lesions judged by the investigator according to Response Evaluation Criteria In Solid Tumors (RECIST V1.1).
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- 0~1 ECOG score.
- Life expectancy ≥ 12 weeks.
- 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).
- 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 trial treatment: 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.
- 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.
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- 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.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Qi Chen, MD, 86-17811921405, chenqimd@163.com
Xizhong Shen, MD
About this study
Official title: Observational Study on the Relationship Between Gut Microbiota and Immunotherapy Response of Non-small Cell Lung Cancer
This study will analyze the composition and diversity of the gut microbiota of patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) through metagenomic high-throughput sequencing methods, and explore the relationship between the gut microbiota and anti-PD-1/PD-L1 treatment response.
This study will further understand the influence and mechanism of the gut microbiota on tumor immunotherapy, and will provide new ideas and theoretical basis for improving the efficacy of tumor immunotherapy by targeting the gut microbiota in the clinic, and benefit more NSCLC patients.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Response to anti-PD-1/PD-L1, Non-response to anti-PD-1/PD-L1
- 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.
Response to anti-PD-1/PD-L1Other
Response to anti-PD-1/PD-L1, after 4 cycles of anti-PD-1/PD-L1 treatment.
Non-response to anti-PD-1/PD-L1Other
Non response to anti-PD-1/PD-L1, after 4 cycles of anti-PD-1/PD-L1 treatment.
| Study group | Role | What they receive |
|---|---|---|
| Responder group | After the 4 cycles of anti-PD-1/PD-L1 mAbs treatment, the investigators evaluated the subjects' response to anti-PD-1/PD-L1, according to the Response Evaluation Criteria In Solid Tumors (RECIST V1.1) or Modified RECIST 1.1 for immune based therapeutics (iRECIST) .
Responders are defined as complete remission, partial remission, or stable disease. Receives: Other: Response to anti-PD-1/PD-L1 | |
| Nonresponder group | After the 4 cycles of anti-PD-1/PD-L1 treatment, the investigators evaluated the subjects' response to anti-PD-1/PD-L1, according to the Response Evaluation Criteria In Solid Tumors (RECIST V1.1) or Modified RECIST 1.1 for immune based therapeutics (iRECIST) .
Nonresponders are defined as disease progression. Receives: Other: Non-response to anti-PD-1/PD-L1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diversity and Composition of gut microbiota
The difference of gut microbiota diversity and composition between Responder group with Non-Responder group. 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: At the end of Cycle 4 (each cycle is 21 days)
Secondary outcomes (3)
Concentration of peripheral blood mononuclear cells
The difference of composition and content of peripheral blood mononuclear cells (CD8+T-cells, NK cells and myelin-sourced inhibitory cells) between Responder group with Non-Responder group. The composition and content of CD8+T-cells, NK cells and myelin-sourced inhibitory cells were analyzed by flow cytometry.
Measured: At the end of Cycle 4 (each cycle is 21 days)
Concentration of tumor immune related cytokines
The difference of the contents of tumor immune related cytokines (IFNγ、TNF、Granzyme A/B、Perforin and et al)between Responder group with Non-Responder group. The contents of tumor immune related cytokines were analyzed by enzyme-linked immunosorbent assay.
Measured: At the end of Cycle 4 (each cycle is 21 days)
Incidence of anti-PD-1/PD-L1 related adverse events
Number of patients with adverse events that received anti-PD-1/PD-L1 treatment
Measured: through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start12 Aug 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xizhong Shen, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682327
- Sponsor's protocol ID
- B2020-300
- Status last verified
- Aug 2021
- First submitted
- 14 Dec 2020
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Relationship Between Gut Microbiota and Immunotherapy Response of Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04682327
- Acronym / sponsor ID
- B2020-300
- Conditions
- Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will analyze the composition and diversity of the gut microbiota of patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) through metagenomic high-throughput sequencing methods, and explore the relationship between the gut microbiota and anti-PD-1/PD-L1 treatment response.
This study will further understand the influence and mechanism of the gut microbiota on tumor immunotherapy, and will provide new ideas and theoretical basis for improving the efficacy of tumor immunotherapy by targeting the gut microbiota in the clinic, and benefit more NSCLC patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Responder group | – | Other: Response to anti-PD-1/PD-L1After the 4 cycles of anti-PD-1/PD-L1 mAbs treatment, the investigators evaluated the subjects' response to anti-PD-1/PD-L1, according to the Response Evaluation Criteria In Solid Tumors (RECIST V1.1) or Modified RECIST 1.1 for immune based therapeutics (iRECIST) . Responders are defined as complete remission, partial remission, or stable disease. |
| Nonresponder group | – | Other: Non-response to anti-PD-1/PD-L1After the 4 cycles of anti-PD-1/PD-L1 treatment, the investigators evaluated the subjects' response to anti-PD-1/PD-L1, according to the Response Evaluation Criteria In Solid Tumors (RECIST V1.1) or Modified RECIST 1.1 for immune based therapeutics (iRECIST) . Nonresponders are defined as disease progression. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with local late/metastasis non-small cell lung cancer treated with the first-line treatment of anti-PD-1/PD-L1 treatment
Key inclusion criteria (10 listed)
- Volunteer to participate in this trial, fully understand this trial, and sign the Informed Consent Form (ICF).
- 18-75 years old on the day of signing the ICF.
- 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.
- receive anti-PD-1/PD-L1 for first-line treatment.
- Have not received systemic treatment for locally advanced/metastatic NSCLC.
Key exclusion criteria (14 listed)
- Before the first administration of the trial treatment: 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Response to anti-PD-1/PD-L1Response to anti-PD-1/PD-L1, after 4 cycles of anti-PD-1/PD-L1 treatment. | Other | Responder group |
| Non-response to anti-PD-1/PD-L1Non response to anti-PD-1/PD-L1, after 4 cycles of anti-PD-1/PD-L1 treatment. | Other | Nonresponder group |
Primary outcome
Diversity and Composition of gut microbiota
Time frame: At the end of Cycle 4 (each cycle is 21 days)
The difference of gut microbiota diversity and composition between Responder group with Non-Responder group. 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.
3 secondary outcomes
Concentration of peripheral blood mononuclear cells
Time frame: At the end of Cycle 4 (each cycle is 21 days)
Concentration of tumor immune related cytokines
Time frame: At the end of Cycle 4 (each cycle is 21 days)
Incidence of anti-PD-1/PD-L1 related adverse events
Time frame: through study completion, up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xizhong Shen, MD, PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 10 inclusion and 14 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 13 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.
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?
Diversity and Composition of gut microbiota (time frame: At the end of Cycle 4 (each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2021.