non-small cell lung cancer
Conditions
Interventions
single arm:Envafolimab plus platinum-based chemotherapy
Sponsors
Sichuan cancer hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Participants who understand the study voluntarily sign the informed consent form. 2. Aged 18-70 years, regardless of gender. 3.No exposure to any prior systemic therapy for lung cancer, diagnosed as non-small cell lung cancer confirmed by imaging and pathological histology, with a clinical stage of stage II-IIIb (according to AJCC TNM staging, 7th edition) as assessed by the investigator. 4.Measurable tumors according to Response Evaluation Criteria in Solid Tumors version 1.1 5.Tumor tissue specimens could be submitted for pathological diagnosis, PD-L1 expression test, and biomarker test prior to enrollment 6. ECOG PS score of 0-1. 7.Major organ function test meet the following requirements 8.Bone marrow function: hemoglobin (Hb) >= 90 g/L; white blood cell count (WBC) >= lower limit of normal; absolute neutrophil value (ANC) >= 1.5 x 10^9 /L; platelet count >= 100 x 10^9 /L. 9. Renal function: Cr = 60 ml/min. 10.Liver function: total bilirubin <= 1.5 x ULN; ALT and AST <= 2.5x ULN. 11. Normal thyroid function: defined as thyroid stimulating hormone (TSH) within the normal range. 12. Willing and able to comply with study scheduled visits, treatment plans, laboratory tests, and other study procedures. 13.Total lung function to withstand planned lung resection 14. Female patients of childbearing potential agree to use contraception for the duration of the study and for 6 months after study completion, have a negative serum or urine pregnancy test within 7 days prior to study entry, and are not breastfeeding; Male patients agree to use contraception for the duration of the study and for 6 months after study completion.
Exclusion criteria
Exclusion criteria: 1. Unresectable diseases and metastatic diseases; 2. Pancoast tumor, large cell neuroendocrine carcinoma, sarcomatoid tumor; NSCLC with EGFR mutation or ALK translocation; 3. Any lung disease that requires corticosteroids (daily dose of prednisone or equivalent drugs> 10 mg) or other immunosuppressive drugs for systemic treatment has been suffered in the 14 days before randomization. 4. Known history of active tuberculosis; 5. Active infection requiring systemic therapy 6. Active autoimmune diseases or immune deficiency diseases. Allow entry for well-controlled type I diabetes, hypothyroidism that only requires hormone replacement therapy, well-controlled celiac disease, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss), or when there is no external cause Next are diseases that are not expected to recur. 7. Uncontrolled active hepatitis B disease. 8. Human immunodeficiency virus (HIV) infection (HIV antibody positive); 9. History of live vaccines within 30 days before the first administration. Including but not limited to the following: mumps, rubella, measles, varicella/shingles (chickenpox), yellow fever, rabies, Bacille Calmette-Guerin (BCG), and typhoid vaccine (inactivated virus vaccine allowed); 10. Received any types of PD-1/PD-L1 drugs or targeted T-cell receptor drugs(CTLA-4O, X-40, etc.). 11.Severe allergic to any of the monoclonal antibody drugs. 12. Severe allergic to any of the drugs in this plan, including pemetrexed, paclitaxel, nab-paclitaxel, docetaxel, cisplatin, and carboplatin etc. 13. Known uncontrolled severe diseases. 14. Any incurable malignancies diagnosed within 5 years prior to the enrollment. 15. Patients with uncontrolled acute or chronic heart diseases, or heart failure with NYHA>= grade2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathologic Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathologic Complete Response;Overall Survival;Event -free Survival;Disease free survival;Adverse Events; | — |
Countries
China
Contacts
Public ContactHe Jintao
Sichuan cancer hospital
Outcome results
None listed