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A study on the correlation between airway and gut microbiome and the immunotherapy efficacy on the comorbidity of chronic obstructive pulmonary disease and lung cancer

A study on the correlation between airway and gut microbiome and the immunotherapy efficacy on the comorbidity of chronic obstructive pulmonary disease and lung cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600125622
Enrollment
Unknown
Registered
2026-05-28
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD), Non-Small Cell Lung Cancer (NSCLC).

Interventions

COPD combined NSCLC group:None

Sponsors

The Second Affiliated Hospital of the Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Cohort 1: Lung cancer group: (1) The patient age is ranging from 18 to 80 years old; (2) No obvious abnormalities were found in the pulmonary function test (FEV1/FVC >=0.7 after inhalation of bronchodilators); (3) Patients with initially treated locally advanced or metastatic NSCLC diagnosed by pathology. No surgical opportunity; (4) At least one measurable target lesion according to RECIST v1.1 criteria; (5) Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; (6) Other malignant tumors are excluded. 2. Cohort 2: COPD combined NSCLC group: (1) The patient age is ranging from 18 to 80 years old; (2) The patient meets the diagnostic criteria for COPD as stipulated in the "Guidelines for Primary Diagnosis, Treatment and Management of Chronic Obstructive Pulmonary Disease in China"; (3) Patients with initially treated locally advanced or metastatic NSCLC diagnosed by pathology. No surgical opportunity; (4) At least one measurable target lesion according to RECIST v1.1 criteria; (5) Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; (6) Other malignant tumors are excluded.

Exclusion criteria

Exclusion criteria: 1. Use antibiotics or supplement probiotics in the recent period (within 3 months); 2. Patients with other lung diseases (such as asthma, bronchiectasis, pulmonary tuberculosis, interstitial lung disease); 3. Patients with severe gastrointestinal diseases; 4. Patients with autoimmune diseases; 5. Those who have previously received systemic anti-tumor treatments such as surgery, chemotherapy, radiotherapy or targeted therapy; 6. Patients with EGFR mutations, ALK fusions, ROS1 fusions, RET fusions, KRAS G12C/D mutation, C797X mutation, NTRK fusion, and BRAF mutation.

Design outcomes

Primary

MeasureTime frame
microbiota characteristics;

Secondary

MeasureTime frame
progression free survival;objective response rate;overall survival;

Countries

China

Contacts

Public ContactBai Li

The Second Affiliated Hospital of the Army Medical University

blpost@126.com+86 180 8301 0686

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026