resectable non-small cell lung caner
Conditions
Interventions
Intervention group:Clostridium Butyricum Tablets combined with Atezolizumab. Clostridium Butyricum Tablets, 2 tablets per dose, 3 times a day, with a 21-day cycle, lasting for 1 year. Atezolizumab int
Sponsors
Peking University Cancer Hospital & Institute
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Signed Informed Consent Form; 2. Aged >= 18 years; 3. For patients undergoing upfront surgery: Eligible participants include those with NSCLC staged pathologically as II-IIIA or IIIB(N2) (per TNM 8th Edition) following complete resection; the presence of extracapsular extension in lymph nodes does not affect eligibility. For patients who received neoadjuvant therapy: Eligible participants include those with pre-treatment clinical stages II-IIIA or IIIB(N2) who demonstrate residual disease in postoperative pathological findings; 4. Accepted types of resection include any of the following: lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy; 5. If mediastinoscopy was not performed preoperatively, it is expected that, at a minimum, mediastinal lymph node systematic sampling will have occurred, though complete mediastinal lymph node dissection (MLND) is preferred. Systematic sampling is defined as removal of at least one representative lymph node at specified levels. MLND entails resection of all lymph nodes at those same levels. For a right thoracotomy, sampling or MLND is required at levels 4 and 7 and for a left thoracotomy, levels 5 and/or 6 and 7; 6. PD-L1 >= 1%; 7. Patients ready for adjuvant treatment with atezolizumab; 8. ECOG 0-1; 9. Adequate hematologic and end-organ function; 10. For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective form(s) of contraception during study treatment until 6 months after the last dose of study treatment.
Exclusion criteria
Exclusion criteria: 1. Patients with clinically visible lesions at baseline after adjuvant chemotherapy; 2. Patients with known EGFR sensitive mutation and ALK rearrangement; 3. Patients with grade 2 or above immune-related adverse events who have previously received immune checkpoint inhibitors; 4. Patients with allergy to Clostridium butyricum tablets; 5. Patients with factors that significantly affect the absorption of oral drugs, such as inability to swallow and intestinal obstruction; 6. History of other primary malignancies within the past 5 years or concurrent malignancy, except for those that have been curatively treated and have a negligible risk of recurrence; 7. Patients with active, known or suspected autoimmune diseases; 8. Patients with severe cardiovascular diseases; 9. Patients with other serious diseases that are not suitable for the study or affect the completion of the study in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in gut microbiota from baseline to 3 months after start of study treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in gut microbiota from baseline to 6 months after start of study treatment;Change in immune lymphocyte subsets from baseline to 3 months after start of study treatment;Change in immune lymphocyte subsets from baseline to 6 months after start of study treatment;2-year Disease-free survival rate;2-year Overall survival rate;Psychological assessment; | — |
Countries
China
Contacts
Public ContactNan Wu, Jun Zhao
Peking University Cancer Hospital & Institute
Outcome results
None listed