Small cell lung cancer
Conditions
Interventions
Experimental group:Envafolimab plus chemotherapy regimen
Sponsors
Shandong First Medical University Affiliated Cancer Hospital (Shandong Cancer Prevention and Treatment Research Institute)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) >=18 years old and 3 months; 11) Adequate organ function, subject must meet the following laboratory criteria: a. In the past 14 days without the use of granulocyte colony-stimulating factor, the absolute value of neutrophil (ANC) >=1.5x10^9/L; b. Platelets >=100× 10^9/L in the past 14 days without blood transfusion; c. Hemoglobin > without blood transfusion or use of erythropoietin within the last 14 days; >90g/L; d. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =60 ml/min; f. Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) <=1.5× ULN; g. Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; h. The myocardial enzyme profile is within the normal range (if the researchers comprehensively judge that the simple laboratory abnormality is not clinically significant, it is also allowed to be included); 12) For female subjects of reproductive age, a urine or serum pregnancy test should be performed within 3 days prior to receiving the first study drug administration (day 1 of cycle 1) and the result is negative; 13) If there is a risk of conception, all subjects (male or female) should use contraception with an annual failure rate of less than 1% for the entire duration of treatment up to 120 days after the last study drug administration of treatment; 14) The subjects voluntarily joined the study, signed written informed consent, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1) histologically or cytologically confirmed mixed SCLC and NSCLC; 2) Received radiation therapy prior to administration of the first study drug, meeting one of the following conditions: a. >=30% of bone marrow had received radiation therapy within 14 days prior to treatment; b. The end time of palliative radiotherapy was within 7 days before the first study drug administration; 3) Malignant diseases other than SCLC diagnosed within 5 years prior to initial administration (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection); 4) is currently participating in an interventional clinical study treatment, or has received other investigational drugs or used investigational devices within 4 weeks prior to initial dosing; 5) Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that target another stimulus or synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137); 6) Received systemic systemic treatment with Chinese patent drugs with anti-lung cancer indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural fluid) within 2 weeks before the first administration; 7) An active autoimmune disease requiring systemic treatment (e.g. with disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to initial administration. Replacement therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy; 8) were receiving systemic glucocorticoid therapy (excluding topical glucocorticoids by nasal spray, inhalation, or other route) or any other form of immunosuppressive therapy within 14 days prior to the first administration of the study; Note: The use of physiological doses of glucocorticoids (<=10 mg/ day of prednisone or equivalent) is permitted; 9) Clinically uncontrollable pleural effusion/abdominal effusion (patients who do not need to drain effusion or who have no significant increase in effusion after 3 days of stopping drainage can be enrolled); 10. Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 11. Individuals who are known to be allergic to the active ingredients or excipients of the investigational drug Envolumab, Etoposide, Carboplatin, Cisplatin, etc; 12. Prior to commencing treatment, there has been insufficient recovery from toxicity and/or complications caused by any intervention measures (i.e. <= grade 1 or baseline, excluding fatigue or hair loss); 13. Known history of human immunodeficiency virus infection (i.e. HIV 1/2 antibody positive); 14. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected is greater than the upper limit of normal value in the laboratory of the research center); Note: hepatitis B patients who meet the following criteria can also be included in the group: (1) Prior to the first administration, if the HBV viral load is less than 1000 copies/ml (200 IU/ml), subjects should receive anti HBV treatment throughout the entire study chemotherapy period to avoid viral reactivation (2) For subjects with anti HBc (+), HBsAg (-), anti HBs (-), and HBV viral load (-), prophylactic anti HBV treatment is not necessary, but close monitoring of viral reactivation is necessary 15. Activ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival(PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate(ORR);Disease Control Rate(DCR);Overall Survival(OS); | — |
Countries
China
Contacts
Public ContactWang Zhehai
Shandong First Medical University Affiliated Cancer Hospital (Shandong Cancer Prevention and Treatment Research Institute)
Outcome results
None listed