Retreated small cell lung cancer without immunotherapy
Conditions
Interventions
Treatment group:Serplulimab Injection
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in clinical research. 2. Male or female subjects >=18 years of age at the time of signing the informed consent form (ICF). 3. Histologically or cytologically confirmed LS-SCLC or ES-SCLC (according to the Veterans Administration Lung Cancer Association [VALG] staging system). 4. LS-SCLC that progressed within 6 months of previous chemoradiotherapy (and radiotherapy ended>1 month) or ES-SCLC that progressed on previous platinum-based therapy. 5. At least one measurable target lesion assessed by the investigator according to RECIST 1.1 requirements within 4 weeks prior to the first dose. 6. ECOG PS score is 0 or 1. 7. Estimated survival time>=12 weeks. 8. Important organs function well, that is, they meet the following criteria [have not received blood transfusion, albumin, recombinant human thrombopoietin, or colony stimulating factor (CSF) treatment within 14 days before the first dose in this study]:Hematology: Neutrophils (ANC) >= 1.5×10^9/L; platelets (PLT) >= 100×10^9/L; hemoglobin (Hb) >= 90 g/L. Liver function: Total bilirubin (TBIL) = 30 g/L. Renal function: 1.5×ULN, creatinine clearance must be >=50 mL/min (calculated according to the Cockcroft-Gault formula). Coagulation function: Activated partial thromboplastin time (APTT) =2+, 24-hour urine protein test is required; if 24-hour urine protein is <1 g, enrollment is allowed. 9. Female subjects must have a negative serum pregnancy test within 14 days before medication, and agree to use effective contraceptive measures during and within 6 months after treatment. Breastfeeding is prohibited during treatment; male patients must agree to use contraceptive measures during treatment. 10. Male patients must satisfy: agree to abstinence (avoid heterosexual intercourse) or use contraception, as follows: When the partner is a female of childbearing potential or the partner is pregnant, male patients must remain abstinent or use condoms to prevent fetal drug exposure during study treatment and for at least 6 months after the last dose of study drug. Regular abstinence (e.g., calendar day, ovulation, basal body temperature, or post-ovulation contraception) and extracoporeal ejaculation are unqualified contraceptive methods.
Exclusion criteria
Exclusion criteria: 1. Known history of severe allergy to any monoclonal antibody (NCI-CTCAE 5.0 grade greater than 3). 2. Patients who have received treatment with other immune checkpoint inhibitors such as PD-1, PD-L1, CTLA-4, etc. 3. Any active infection requiring systemic anti-infective treatment occurs within 14 days before the first dose. 4. Myocardial infarction, poorly controlled arrhythmia (including QTc interval >=450 ms for males and >=470 ms for females) within 6 months prior to first dose (QTc interval calculated by Fridericia formula); or cardiac insufficiency class III-IV according to NYHA criteria or left ventricular ejection fraction <50% by echocardiography; or pleural effusion, pericardial effusion or ascites requiring clinical intervention. 5. The patients had uncontrollable or symptomatic hypercalcemia (1.5 mmol/L ionized calcium or calcium 12 mg/dL or corrected serum calcium ULN). 6. Patients who have had interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc., in the investigator's judgment, may interfere with the detection and management of suspected drug-related pulmonary toxicity at the time of screening. 7. Patients with hepatitis B [hepatitis B surface antigen (HBsAg) positive and HBV-DNA testing indicates virus replication]; or patients with hepatitis C [hepatitis C virus (HCV) antibodies positive and HCV-RNA testing indicates virus replication]; or positive syphilis screening (positive for specific antibody testing, except for those who are negative for non-specific antibody testing and confirmed to be inactive infection based on clinical judgment); or a known history of positive human immunodeficiency virus (HIV) or positive HIV screening; 8. The patients had known active or suspected autoimmune disease. Patients in stabtale state who do not require systemic immunosuppressants are allowed to be enrolled. 9. Have other active malignancy within 5 years or at the same time. Restricted tumors that have been cured for more than 5 years, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, and breast cancer in situ, can be enrolled. 10. Those who received a live or attenuated vaccine within 28 days before the first dose or had plans to receive such a vaccine during the study; however, inactivated virus vaccines for seasonal influenza are allowed. 11. Radical radiation therapy within 3 months prior to the first dose. 12. Subjects with spinal cord compression who have not been treated radically with surgery and/or radiotherapy. 13. Persons with deep vein thrombosis, who are using anticoagulant or platelet therapy, or who have experienced deep vein thrombosis or severe bleeding due to previous use of anti-angiogenic drugs. 14. People with poor blood pressure control (poor control is defined as: blood pressure still =160/100mmHg under the best hypertension treatment regimen). 15. Having undergone major surgery within 28 days before the first dose (definition of major surgery in this study: surgery that requires at least 3 weeks of postoperative recovery before receiving treatment in this study). 16. Those who are participating in other clinical studies or who have participated in any other clinical trials (including drugs and devices, etc.) within 3 months or 5 half-lives (whichever is longer) prior to screening and have received intervention. 17. Patients who are preparing for
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;objective response rate;One-year Overall Survival Rate;safety; | — |
Countries
China
Contacts
Public ContactJie Zhang
Shanghai Pulmonary Hospital
Outcome results
None listed