Mon-Small Cell Lung Cancer(NSCLC)
Conditions
Interventions
Queue 1 (Morning Group):Complete each cycle of chemotherapy and Serplulimab infusion before 12:00
Queue 2 (Middle Group):Complete each cycle of chemotherapy and Serplulimab infusion between 12:00 and 15:00
Queue 3 (Evening Group):Complete each cycle of chemotherapy and Serplulimab infusion after 15:00
Sponsors
Tangdu Hospital, Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent form and voluntarily join this study; 2. Histologically confirmed NSCLC stage II–IIIb (AJCC 8th edition); 3. Suitable for receiving neoadjuvant therapy and surgery; 4. Expected to achieve R0 resection; 5. Aged 18–75 years, of any gender; 6. ECOG PS 0–1 (see Appendix 1); 7. No prior anti-tumor treatment for non-small cell lung cancer, including radiotherapy, chemotherapy, or surgery; 8. Planned to undergo surgery after completing neoadjuvant therapy; 9. No contraindication to surgery; 10. Major organ functions are normal, including: (1) Complete blood count (no use of any blood components, growth factors, leukocyte stimulants, platelet stimulants, or anemia-correcting drugs within 14 days before the first study drug administration): neutrophil count >=1.5×10^9/L; platelet count >=100×10^9/L; hemoglobin >=90 g/L; (2) Blood biochemistry: total bilirubin =50 mL/min; (3) Coagulation function: international normalized ratio (INR) <=1.5×ULN; activated partial thromboplastin time (APTT) <=1.5×ULN; 11. Female participants of childbearing potential must have a negative serum pregnancy test within 72 hours before starting study drug administration and must use effective contraception during the trial and for at least 3 months after the last dose (e.g., IUD, contraceptive pills, or condoms); male participants with female partners of childbearing potential should be surgically sterile or agree to use effective contraception during the trial and for 3 months after the last dose; 12. Complete the "Morningness-Eveningness Questionnaire" assessment before enrollment; 13. Participants demonstrate good compliance and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Previously received anti-PD-1/PD-L1 therapy or lung cancer-related chemotherapy; 2. Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 3. Poor nutritional status, BMI 10 mg/day prednisone or equivalent); inhaled or local steroids and corticosteroid replacement therapy >10 mg/day prednisone or equivalent are allowed in the absence of active autoimmune disease; (3) Received live attenuated vaccines within 4 weeks before the first use of the study drug; (4) Major surgery or severe trauma within 4 weeks before the first use of the study drug; 6. Have any active autoimmune disease or a history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (considered after hormone replacement therapy); patients with psoriasis or childhood asthma/allergies fully resolved and requiring no intervention in adulthood may be considered, but those requiring medical intervention with bronchodilators cannot be included; 7. History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation; 8. Presence of cardiac clinical symptoms or diseases that are not well controlled, including but not limited to: (1) heart failure of NYHA class II or above, (2) unstable angina, (3) myocardial infarction within the past year, (4) clinically significant supraventricular or ventricular arrhythmias that are uncontrolled despite clinical intervention or remain poorly controlled after intervention; 9. Severe infection (CTCAE > grade 2) within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, infection-related complications, etc.; baseline chest imaging indicating active pulmonary inflammation, symptoms and signs of infection within 14 days before the first use of the study drug, or the need for oral or intravenous antibiotic treatment, except for preventive use of antibiotics; 10. Active pulmonary tuberculosis infection detected through medical history or CT, or history of active pulmonary tuberculosis within 1 year before enrollment, or history of active pulmonary tuberculosis more than 1 year ago but untreated according to standard regimen; 11. Presence of active hepatitis B (HBV DNA >= 2000 IU/mL or 104 copies/mL) or hepatitis C (positive HCV antibody and HCV RNA above the detection limit of the assay); 12. Diagnosis of other malignant tumors within 5 years before the first use of the study drug, except for malignancies with low risk of metastasis or death (5-year survival rate > 90%), such as adequately treated basal cell carcinoma or squamous cell carcinoma of the skin or cervical carcinoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological Complete Response, pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological Response, MPR;Event-Free Survival, EFS;Overall Survival, OS;R0 resection rate;Treatment-related adverse events;Objective Response Rate, ORR; | — |
Countries
China
Contacts
Public ContactXiaolong Yan
Tangdu Hospital,Air Force Medical University
Outcome results
None listed