Lung Cancer
Conditions
Interventions
Experimental group:First-line treatment with Envolimab (Envafolimab) combined with carboplatin/cisplatin and etoposide, and 4 cycles later with Envafolimab (Envafolimab) monotherapy for maintenance un
Sponsors
Oncology Department of PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent before implementing any trial-related procedures; 2. Aged >=18 years and 3 months; 12. With sufficient organ function, patients need to meet the following laboratory indicators: (1) The absolute value of neutrophils (ANC) >=1.5 x 10^9/L without using granulocyte colony stimulating factor in the past 14 days; (2) In the case of no blood transfusion in the past 14 days, platelets >=100 x 10^9/L; (3) If there is no blood transfusion or erythropoietin in the past 14 days, hemoglobin > 9g/dL; (4) Total bilirubin ULN but direct bilirubin = 60 ml/min; (7) With good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) <= 1.5 times ULN; (8) Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is outside the normal range, subjects whose total T3 (or FT3) and FT4 are within the normal range can also be included in the group; (9) Myocardial enzyme spectrum is within the normal range (such as simple laboratory abnormalities that are judged by the investigator to be of no clinical significance are also allowed to be included); 13. For female patients of childbearing age, a urine or serum pregnancy test and the result should be negative within 3 days before receiving the f
Exclusion criteria
Exclusion criteria: 1. Mixed SCLC and NSCLC confirmed by histology or cytology; 2. Have received any systemic anti-tumor therapy for ES-SCLC in the past; 3. Received radiotherapy before the first study drug administration, and meets one of the following conditions: (1) >= 30% of bone marrow received radiotherapy within 14 days before treatment (2) Received radiotherapy for lung lesions within 6 weeks before treatment with a dose of >30 Gy (participants in the group must recover from the toxicity of previous radiotherapy to grade 1 or below, without glucocorticoid therapy and no history of radiation pneumonia) (3) The end of palliative radiotherapy is within 7 days before the first study drug administration; 4. Diagnosis of other malignant diseases other than SCLC within 5 years before the first administration (excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma, and/or radically excised carcinoma in situ); 5. Patients currently participating in interventional clinical research treatment, or have received other research drugs or used research devices within 4 weeks before the first administration; 6. Have received the following therapies in the past: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or for another stimulating or synergistic inhibition of T cell receptors (for example, CTLA-4, OX-40, CD137) drug; 7. Received Chinese patent medicines with anti-lung cancer indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural fluid) systemic systemic treatment within 2 weeks before the first administration; 8. With active autoimmune diseases that requires systemic treatment (such as the use of disease-relieving drugs, glucocorticoids, or immunosuppressive agents) occurred within 2 years before the first administration, alternative therapies (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) are not considered systemic treatments; 9. Patients received systemic glucocorticoid therapy (excluding nasal spray, inhaled or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first administration of the study; Note: The use of physiological doses of glucocorticoids (<= 10 mg/day prednisone or equivalent drugs) is allowed; 10. With clinically uncontrollable pleural effusion/abdominal effusion (patients who do not need to drain the effusion or stop drainage for 3 days without a significant increase in effusion can be included in the group); 11. With allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 12. People who are known to be allergic to active ingredients or excipients such as envolimab, etoposide, carboplatin, cisplatin, etc. 13. Patients,before starting treatment, have not fully recovered from toxicity and/or complications caused by any intervention (<= Grade 1 or reached baseline, excluding fatigue or hair loss); 14. With human immunodeficiency virus (HIV) infection history (HIV 1/2 antibody positive); 15. With untreated active hepatitis B (defined as HBsAg positive and the number of copies of HBV-DNA detected at the same time is greater than the upper limit of the normal value of the laboratory department of the research center); Note: Hepatitis B patients who meet the following criteria can also be included in the group: (1) Before the first administration, the HBV viral load i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate, ORR;disease control rate, DCR;duration of remission, DoR ;overall survival, OS;adverse event rate; | — |
Countries
China
Contacts
Public ContactJiao Shunchang
The General Hospital of People's Liberation Army(301 hospital)
Outcome results
None listed