Non small cell lung cancer
Conditions
Interventions
experimental group:Preoperative neoadjuvant chemotherapy combined with 300mg every 3 weeks (Q3W) of Envafolimab for 3 cycles
postoperative adjuvant chemotherapy Q3W for 3 cycles, followed by 1 year of maintenance therapy with Envafolimab monotherapy (300mg, Q3W).
control group:Neoadjuvant chemotherapy at 3-week intervals for 3 cycles
adjuvant chemotherapy at 3-week intervals for 3 cycles postoperatively.
Sponsors
Aerospace Center Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. I have fully understood and voluntarily signed the Informed Consent Form (ICF) for this study; 2. Age range of 18-70 years old, gender not limited; 3. Previously untreated and histologically confirmed resectable stage II, IIIA, IIIB (AJCC staging 8th edition) NSCLC; TNM staging can be confirmed through PET-CT or pathological biopsy; 4. According to the evaluation criteria for solid tumor efficacy version 1.1, there are measurable lesions; 5. Before enrollment, tumor tissue specimens can be submitted for pathological diagnosis, PD-L1 expression, and biomarker detection (tumor tissue specimens must be fresh or archived samples obtained within 3 months before enrollment; tumor tissue specimens must be histological samples, including but not limited to coarse needle, hollow needle puncture tissue, bronchoscope clamp tissue, surgical resection samples; fine needle puncture, bronchial brush examination samples are not acceptable); 6. ECOG score 0-1; 7. Good organ function; 8. Hematology: Absolute neutrophil count (ANC) >= 1500/µ L; Platelets >= 100000/µ L; Hemoglobin >= 9.0g/dL or >= 5.6 mmol/L; 9. Kidney: Serum creatinine 1.5 × ULN, direct bilirubin is within normal limits; AST (SGOT) and ALT (SGPT) <= 2.5 × ULN; 11. Endocrine system: Thyroid stimulating hormone (TSH) is within normal limits. Note: If TSH is not within the normal range at baseline, and if T3 and free T4 are within the normal range, the subject still meets the inclusion criteria; Coagulation function: International normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (aPTT) <= 1.5 × ULN, except for subjects undergoing anticoagulant therapy as long as PT or aPTT is within the prescribed range of use of the anticoagulant drug; 12. Willing and able to comply with the visit, treatment plan, laboratory tests, and other research procedures outlined in the research plan; 13. According to the surgeon's assessment, the total lung function can withstand the proposed lung resection surgery; 14. Women of childbearing age must undergo a serum pregnancy test within 3 days before their first medication, and the result must be negative. Female participants of childbearing age and male participants with partners of childbearing age must agree to use efficient contraception methods during the study period and within 180 days after the last administration of the study drug.
Exclusion criteria
Exclusion criteria: 1. Existence of unresectable or metastatic diseases; 2. NSCLC, large cell neuroendocrine carcinoma (LCNEC), and sarcomatoid tumors involving the upper sulcus; Non squamous NSCLC subjects with known EGFR mutations or ALK translocations; 3. Early stage NSCLC that has received systemic anti-cancer treatment in the past, including experimental drug therapy; A history of non infectious pneumonia/interstitial lung disease requiring steroid treatment, or current pneumonia/interstitial lung disease requiring steroid treatment; 4. Known history of active tuberculosis; 5. Known to have active infections that require systematic treatment; 6. Any subjects with known or suspected autoimmune diseases or immune deficiencies, except for those with a history of hypothyroidism who do not require hormone therapy or are receiving physiological dose hormone replacement therapy; Subjects with stable type I diabetes whose blood sugar is controlled; 7. Uncontrolled active hepatitis B (defined as hepatitis B B virus surface antigen [HBsAg] test result in screening period is positive, and HBV-DNA test value is higher than the upper limit of normal value in the laboratory department of the research center; (Subjects with HBV-DNA levels5 years) and expected curative outcomes after treatment (e.g. adequately treated cervical carcinoma in situ, basal or squamous cell carcinoma, and curative surgery for ductal carcinoma in situ) may be excluded. 15. Grade III-IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmia; 16. Any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, occurred within the 6 months prior to being selected for treatment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main pathological reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event free survival period;Disease-free survival period;Overall survival; | — |
Countries
China
Contacts
Public ContactDou Xuejun
Aerospace Center Hospital
Outcome results
None listed