Lung Cancer (NSCLC)NCT06613308
Association Between Microbiome and the Efficacy and Safety of PD-1/PD-L1 Blockade in Resectable NSCLC
An observational study of Lung Cancer (NSCLC), run by Capital Medical University.
Trial summary
This study will investigate the relationship between respiratory and gut microbiome and PD-1/PD-L1 immune checkpoint inhibitor efficacy and immune-related adverse events (irAE) in patients with non-small cell lung cancer (Stage IIA-IIIB） Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer (NSCLC)
- What is being tested?
- Neoadjuvant immunotherapy combined with chemotherapy and Neoadjuvant chemotherapy
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2024to 31 Dec 2025
- 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: The neoadjuvant cohort of patients with non-small cell lung cancer (NSCLC) (stages IIA to selective stage IIIB; squamous or non-squamous cell) who are receiving a PD-1/PD-L1 monoclonal antibody in conjunction with platinum-containing two-agent standard chemotherapy (Arm 1) or platinum-containing two-agent standard chemotherapy (Arm 2).
Who may be able to join
- 18-75 years old;
- first-diagnosed, driver gene-negative non-small cell lung cancer patients with histopathological confirmed diagnosis (Stage IIA-IIIB);
- at least 1 measurable lesion as defined by RECIST version 1.1; an Eastern Cooperative Oncology Group (ECOG) physical status score of 0-1;
- no prior systemic therapy or radiotherapy;
- the patients are eligible for indications for surgical resection and amenable to - neoadjuvant immunotherapy or chemotherapy after multidisciplinary evaluation;
- signing the written consent before enrollment in the study;
- participants need to have adequate pulmonary ventilation and diffusion function to allow surgical resection by pre-enrolment pulmonary function testing;
Who cannot join
- refusal of participation or inability to give a clear consent;
- requiring treatment with systemic glucocorticoids and other - immunosuppressive agents;
- use of antibiotics within the previous 3 months or the presence of an infectious disease requiring antibiotic therapy;
- probiotics within 3 months prior to enrolment;
- presence of obstructive pneumonia, cancerous cavities, active tuberculosis;
- the presence of bronchiectasis, combined lung infections, pulmonary fibrosis, uncontrolled diabetes mellitus;
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- the presence of primary tumors elsewhere;
- receiving chemotherapy or any other cancer treatment prior to enrolment;
- participants with brain metastases confirmed by brain MRI with contrast prior to enrolment;
- active or pre-existing autoimmune disease;
- the presence of uncontrolled comorbidities, including heart failure, uncontrolled hypertension, unstable angina, interstitial lung disease;
- positive test for hepatitis B surface antigen or hepatitis C ribonucleic acid requiring treatment;
- known positive history or positive test results for human immunodeficiency virus or acquired immunodeficiency syndrome (AIDS);
- history of allergy to study drug components;
- women who are pregnant or breastfeeding;
- previous treatment with anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibodies.
Trial locations and contacts
No sites are listed yet.
Dong Liu, M.D. contact
About this study
Official title: Association Between Respiratory Tract and Gut Microbiome and the Efficacy and Safety of PD-1/PD-L1 Blockade in Resectable Non-small-cell Lung Cancer: a Single-center Cohort Study
This study will investigate the relationship between respiratory and gut microbiome and PD-1/PD-L1 immune checkpoint inhibitor efficacy and immune-related adverse events (irAE) in patients with non-small cell lung cancer (Stage IIA-IIIB）
- Conditions
- Lung Cancer (NSCLC)
- Being tested
- Neoadjuvant immunotherapy combined with chemotherapy, Neoadjuvant chemotherapy
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant immunotherapy combined with chemotherapyDrug
The treatment regimen consisted of a PD-1/PD-L1 monoclonal antibody in combination with a platinum-containing two-agent standard chemotherapy regimen administered every three weeks. Following two to four cycles of therapy, patients who demonstrated no evidence of disease progression were eligible for surgical resection, which was performed within three to four weeks after the conclusion of the last neoadjuvant therapy. Consolidation with a PD-1/PD-L1 monoclonal antibody was initiated within three to eight weeks after surgery and continued every three weeks. The efficacy of the treatment was evaluated according to the irRECIST criteria. Chemotherapy regimens were selected based on tumour histology and investigator judgement. In the event of poor tolerability, patients may switch between cisplatin or carboplatin treatments.
Neoadjuvant chemotherapyDrug
A platinum-containing two-agent standard chemotherapy regimen was administered every three weeks. Following a two-to-four-cycle therapy, if the patients were evaluated without progressive disease, patients undergo surgical resection within three to four weeks of the final neoadjuvant treatment. Postoperative adjuvant chemotherapy is then conducted in accordance with the recommended regimen outlined in the 2022 edition of the CSCO Guidelines for the Diagnosis and Treatment of Non-Small Cell Lung Cancer. The efficacy of the treatment was evaluated in accordance with the RECIST 1.1 criteria.
The chemotherapy regimens were selected based on the tumor histology and the judgement of the investigators, in accordance with the standard clinical practice. In the event of poor tolerability, patients may switch between cisplatin or carboplatin treatments.
| Study group | Role | What they receive |
|---|---|---|
| Arm1(Neoadjuvant immunotherapy combined with chemotherapy) | Not described Receives: Drug: Neoadjuvant immunotherapy combined with chemotherapy | |
| Arm2(Neoadjuvant chemotherapy) | Not described Receives: Drug: Neoadjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathological response (mPR)
defined as ≤10% residual live tumor tissue in lung cancer samples resected after neoadjuvant therapy as assessed by the central pathology laboratory.
Measured: Whithin time from enrollment to surgery
Secondary outcomes (7)
Pathologic complete response (pCR)
defined as the absence of live tumour cells in lung cancer specimens resected after neoadjuvant therapy and in all sampled local lymph nodes according to central pathology laboratory assessment. Patients who are not evaluable according to the central pathological assessment (including patients with R2 margins) or who do not have a surgical specimen will not be considered to have achieved a pCR (e.g. remission will be recorded as 'not evaluable' or 'missing', as appropriate).
Measured: Whithin time from enrollment to surgery
Disease free survival (DFS)
defined as the time from surgery to the first recurrence of disease (local or distant) or all-cause death, whichever occurs first. DFS was captured only for events after surgery.
Measured: Whithin 1 year after surgery
Overall survival (OS)
defined as time from enrolment to all-cause death
Measured: Whithin 1 year after enrollment
Immune-related adverse event (irAE)
defined as all levels of adverse drug reactions in antitumor immunotherapy that are judged to be related to immune mechanisms, excluding non-specific infusion reactions.
Measured: Whithin 1 year after enrollment
Changes in microbiomics in respiratory tract and gut
Defined as microbial composition, diversity, and functional activity measured by 16S RNA sequencing
Measured: Whithin 1 year after enrollment
Radiological response
Defined as radiographic change assesed by RECIST 1.1.
Measured: Whithin time from enrollment to surgery
Changes in single-cell immune repertoire
Defined as diversity of immune receptors (e.g. TCR and BCR) for T and B cells in lung tissues
Measured: Whithin time from enrollment to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start25 Sep 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- China-Japan Friendship Hospital
- Responsible party
- Principal investigator, Bin Cao, China-Japan Friendship Hospital
- Investigators
- science and technology center, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613308
- Sponsor's protocol ID
- 2022-YJXBF-03-01
- Status last verified
- Aug 2024
- First submitted
- 15 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Respiratory Tract and Gut Microbiome and the Efficacy and Safety of PD-1/PD-L1 Blockade in Resectable Non-small-cell Lung Cancer: a Single-center Cohort Study
- ClinicalTrials.gov ID
- NCT06613308
- Acronym / sponsor ID
- 2022-YJXBF-03-01
- Conditions
- Lung Cancer (NSCLC)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- China-Japan Friendship Hospital
- Study start
- 25 Sep 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Sep 2024 (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 investigate the relationship between respiratory and gut microbiome and PD-1/PD-L1 immune checkpoint inhibitor efficacy and immune-related adverse events (irAE) in patients with non-small cell lung cancer (Stage IIA-IIIB）
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm1(Neoadjuvant immunotherapy combined with chemotherapy) | – | Drug: Neoadjuvant immunotherapy combined with chemotherapy |
| Arm2(Neoadjuvant chemotherapy) | – | Drug: Neoadjuvant chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The neoadjuvant cohort of patients with non-small cell lung cancer (NSCLC) (stages IIA to selective stage IIIB; squamous or non-squamous cell) who are receiving a PD-1/PD-L1 monoclonal antibody in conjunction with platinum-containing two-agent standard chemotherapy (Arm 1) or platinum-containing two-agent standard chemotherapy (Arm 2).
Key inclusion criteria (7 listed)
- 18-75 years old;
- first-diagnosed, driver gene-negative non-small cell lung cancer patients with histopathological confirmed diagnosis (Stage IIA-IIIB);
- at least 1 measurable lesion as defined by RECIST version 1.1; an Eastern Cooperative Oncology Group (ECOG) physical status score of 0-1;
- no prior systemic therapy or radiotherapy;
- the patients are eligible for indications for surgical resection and amenable to - neoadjuvant immunotherapy or chemotherapy after multidisciplinary evaluation;
Key exclusion criteria (16 listed)
- refusal of participation or inability to give a clear consent;
- requiring treatment with systemic glucocorticoids and other - immunosuppressive agents;
- use of antibiotics within the previous 3 months or the presence of an infectious disease requiring antibiotic therapy;
- probiotics within 3 months prior to enrolment;
- presence of obstructive pneumonia, cancerous cavities, active tuberculosis;
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 |
|---|---|---|
| Neoadjuvant immunotherapy combined with chemotherapyThe treatment regimen consisted of a PD-1/PD-L1 monoclonal antibody in combination with a platinum-containing two-agent standard chemotherapy regimen administered every three weeks. Following two to four cycles of therapy, patients who demonstrated no evidence of disease progression were eligible for surgical resection, which was performed within three to four weeks after the conclusion of the last neoadjuvant therapy. Consolidation with a PD-1/PD-L1 monoclonal antibody was initiated within three to eight weeks after surgery and continued every three weeks. The efficacy of the treatment was evaluated according to the irRECIST criteria. Chemotherapy regimens were selected based on tumour histology and investigator judgement. In the event of poor tolerability, patients may switch between cisplatin or carboplatin treatments. | Drug | Arm1(Neoadjuvant immunotherapy combined with chemotherapy) |
| Neoadjuvant chemotherapyA platinum-containing two-agent standard chemotherapy regimen was administered every three weeks. Following a two-to-four-cycle therapy, if the patients were evaluated without progressive disease, patients undergo surgical resection within three to four weeks of the final neoadjuvant treatment. Postoperative adjuvant chemotherapy is then conducted in accordance with the recommended regimen outlined in the 2022 edition of the CSCO Guidelines for the Diagnosis and Treatment of Non-Small Cell Lung Cancer. The efficacy of the treatment was evaluated in accordance with the RECIST 1.1 criteria. The chemotherapy regimens were selected based on the tumor histology and the judgement of the investigators, in accordance with the standard clinical practice. In the event of poor tolerability, patients may switch between cisplatin or carboplatin treatments. | Drug | Arm2(Neoadjuvant chemotherapy) |
Primary outcome
Major pathological response (mPR)
Time frame: Whithin time from enrollment to surgery
defined as ≤10% residual live tumor tissue in lung cancer samples resected after neoadjuvant therapy as assessed by the central pathology laboratory.
7 secondary outcomes
Pathologic complete response (pCR)
Time frame: Whithin time from enrollment to surgery
Disease free survival (DFS)
Time frame: Whithin 1 year after surgery
Overall survival (OS)
Time frame: Whithin 1 year after enrollment
Immune-related adverse event (irAE)
Time frame: Whithin 1 year after enrollment
Changes in microbiomics in respiratory tract and gut
Time frame: Whithin 1 year after enrollment
Radiological response
Time frame: Whithin time from enrollment to surgery
Changes in single-cell immune repertoire
Time frame: Whithin time from enrollment to surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
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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.
Dong Liu, M.D. contact
science and technology center principal investigator
China-Japan Friendship Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer (NSCLC), run by Capital Medical University.
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 16 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 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Yeming Wang, M.D. (+86 84206264, wwyymm_love@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathological response (mPR) (time frame: Whithin time from enrollment to surgery). 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 25 Sep 2024.