Non-small cell lung cancer
Conditions
Interventions
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years old. 2. Histologically or cytologically confirmed stage IIIb-IV non-small cell lung cancer (NSCLC). 3. General condition: ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1. 4.Receiving first-line treatment with immune checkpoint inhibitor (ICI) in combination with chemotherapy. 5. No prior systemic therapy for NSCLC. 6. At least one measurable lesion as determined by the investigator based on RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1. 7. No EGFR (epidermal growth factor receptor) or ALK (anaplastic lymphoma kinase) gene mutation positivity. If EGFR/ALK mutation status is unknown, testing is not mandatory. 8. Understand the study procedures and content, and voluntarily sign a written informed consent form. 9. Good compliance, able to cooperate with the collection of specimens at various time points and provide corresponding clinical information.
Exclusion criteria
Exclusion criteria: 1. Study participants with a prior history of other malignancies, unless it is carcinoma in situ that has achieved complete remission at least 5 years prior to screening and does not or is not expected to require other treatment during the study period; 2. Patients with active autoimmune disease or history of autoimmune disease but may recur; 3. Have received systemic immunomodulatory agents (including but not limited to interferon, interleukin-2 and tumor necrosis factor) within 4 weeks prior to enrollment; 4. Any condition requiring systemic treatment with corticosteroids (prednisone at a dose higher than I0mg/day or equivalent dose of similar drugs) or other immunosuppressants within =2 weeks of intravenous antibiotic administration, bacteremia, severe pneumonia, etc.; 10. Any major surgery within <=28 days prior to enrollment; 11. Female study participants who are pregnant, lactating, or planning to become pregnant during the study; 12. Patients with hearing impairment; 13. Participate in another therapeutic clinical trial at the same time; 14. Any other medical (such as pulmonary, metabolic, endocrine or nervous system diseases, congenital diseases, etc.), psychiatric disorders, or social status that the investigator believes may interfere with the rights, safety, health or ability to sign informed consent, cooperate and participate in the study, or interfere with the evaluation of study drugs, the interpretation of the safety of study participants or the results of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immune-related indicators;Median survival time;Median progression-free survival;Immune-related adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Circulating tumor cell or ctDNA;Circulating SIA-IgG;Objective response rate; | — |
Countries
China
Contacts
Public ContactXiao Lin
Department of Clinical Laboratory, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed