NSCLC
Conditions
Interventions
single-arm:During the preoperative neoadjuvant treatment period, subjects will receive 3-4 cycles of preoperative neoadjuvant treatment: Envolizumab 300mg, Q3W, subcutaneous injection
Platinum containing dual drug chemotherapy Q3W, administered on the first day of each cycle. The chemotherapy regimen should refer to the guidelines or clinical experience to choose platinum+pemetrexe
Sponsors
Henan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Fully understand and voluntarily sign the Informed Consent Form (ICF) for this study; 2. Age>18 years old, regardless of gender; 3. Resectable IIB-IIIB stage (AJCC staging, 8th edition) NSCLC without prior treatment and histologically confirmed; TNM staging can be confirmed through imaging or pathological biopsy; 4. No EGFR/ALK mutation 5. According to the evaluation standard for solid tumor efficacy version 1.1, there are measurable lesions; 6. Before enrollment, tumor tissue samples can be submitted for pathological diagnosis and PD-L1 expression (tumor tissue samples must be fresh or archived samples obtained within 3 months prior to enrollment; tumor tissue samples must be histological samples, including but not limited to coarse needle and hollow needle puncture tissues, bronchoscopic clamp tissue acquisition, surgical resection samples; fine needle puncture, bronchial brush biopsy samples are not accepted); 7. ECOG score 0-1; 8. Good organ and bone marrow function; 9. Willing and able to follow the visit, treatment plan, laboratory examination, and other research procedures of the research plan; 10. According to the evaluation of the surgeon, the total lung function can withstand the planned lung resection surgery; 11. Women of childbearing age must undergo a serum pregnancy test within 3 days before the first medication use, and the result is 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 medication.
Exclusion criteria
Exclusion criteria: 1. Existence of unresectable or metastatic diseases; 2.NSCLC involving upper sulcus, large cell neuroendocrine carcinoma (LCNEC), and sarcomatoid tumors involving the superior sulcus; 3. Early NSCLC patients who have previously received systemic anti-cancer treatment, including experimental drug therapy; Have a history of non infectious pneumonia/interstitial lung disease requiring steroid treatment, or currently have 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 known or suspected autoimmune disease or immune deficiency patient, except for patients with a history of hypothyroidism who do not require hormone therapy or are receiving physiological dose hormone replacement therapy; Stable type I diabetes patients with blood glucose control; 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 of the research center; (patients with HBV-DNA content<500 IU/mL measured within 28 days before enrollment, who have received at least 14 days of local standard antiviral treatment and are willing to continue to receive antiviral treatment during the study period can be included in the group); Patients with active hepatitis C (defined as those who tested positive for hepatitis C virus surface antibody [HCsAb] during the screening period and were positive for HCV-RNA); 8. Known human immunodeficiency virus (HIV) infection (known HIV antibody positive); 9. Inoculate the live vaccine within 30 days before the first administration. Including but not limited to: mumps, rubella, measles, chickenpox/shingles (chickenpox), yellow fever, rabies, BCG vaccine, and typhoid vaccine (inactivated virus vaccine allowed); 10. Previously received treatment with PD-1/PD-L1 drugs or another drug targeting T cell receptors (such as CTLA-4, OX-40, etc.); 11. Has experienced severe allergic reactions to other monoclonal antibodies; 12. Have a history of severe allergies to chemotherapy drugs such as pemetrexed, paclitaxel, albumin paclitaxel, docetaxel, cisplatin, carboplatin, etc; 13. Other researchers believe that it is not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major pathologic response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;pathologic complete remission rate;Event-free survival;safety; | — |
Countries
China
Contacts
Public ContactWei Li
Henan Provincial People's Hospital
Outcome results
None listed