Extensive-stage small cell lung cancer
Conditions
Interventions
EC + Suluilumonab combined with Carvedilol group:EC/E regimen chemotherapy (Etoposide + Carboplatin) combined with Suluilumonab, and combined with Carvedilol treatment. Carvedilol was started 3 days b
if hemodynamic stability is achieved (pulse >= 60 beats/min, systolic blood pressure > 90 mmHg, diastolic blood pressure >= 60 mmHg), dose adjusted to 6.25mg BID
if stability criteria not met, maintain at 3.125mg BID. This dose was continued until tumor progression. Recommended dose of Suluilumonab is 4.5 mg/kg, intravenous injection every 3-4 weeks.
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years at the time of signing the informed consent form, regardless of gender; 2. Histopathologically diagnosed with small cell lung cancer; 3. Extensive-stage small cell lung cancer (ES-SCLC); 4. First-line treatment; 5. Brain metastasis status at enrollment must meet one of the following criteria: a) No brain metastasis; b) Stable brain metastasis, defined as absence of central nervous system symptoms; or clinically stable for at least 4 weeks prior to enrollment with all central nervous system symptoms returned to baseline; no evidence of new or enlarging brain metastases; and no requirement for glucocorticoids or anticonvulsants for at least 2 weeks prior to enrollment; 6. At least one measurable target lesion not previously irradiated as assessed by the investigator according to RECIST v1.1; 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 8. Life expectancy >=12 weeks; 9. Adequate organ and bone marrow function (without transfusion, recombinant human thrombopoietin, or colony-stimulating factor support within 2 weeks prior to the first dose), defined as follows: a) Hematology: neutrophil count (NEUT#) >=1.5×10^9/L; platelet count (PLT) >=100×10^9/L; hemoglobin >=100 g/L; b) Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =30 g/L; for subjects with baseline liver metastases, ALT and AST =50 mL/min (calculated using the standard Cockcroft-Gault formula); d) Coagulation: international normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) <=1.5×ULN; 10. Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to use effective medical contraceptive methods from the time of signing the informed consent form until 6 months after the last dose; 11. Subjects voluntarily participate in this study, sign the informed consent form, and are able to comply with the scheduled visits and related procedures specified in the protocol.
Exclusion criteria
Exclusion criteria: 1. Known allergy to the study drugs; 2. Pregnant or lactating women, or those planning a pregnancy during the study period; 3. Patients with urinary tract obstruction; 4. Chronic renal insufficiency: serum creatinine greater than 2 mg/dL; 5. Inability to take oral medication; 6. Patients with autoimmune diseases or those who have received immunosuppressive therapy within the past six months; 7. Patients with active liver disease; 8. Patients with acute liver failure or decompensated cirrhosis; 9. Presence of active infection requiring systemic therapy; 10. Immunocompromised patients, such as those with HIV infection; 11. Known presence of other malignant tumors that are progressive or require active treatment; 12. Patients who have not recovered from adverse reactions caused by other medications; 13. Patients with mental illness or substance abuse; 14. Other factors that may confound the results; 15. Concurrent treatment with other drugs that may affect immune system function; 16. Contraindications to non-selective beta-blockers (NSBBs), including heart block, sinus bradycardia, severe hypotension, heart failure, chronic obstructive pulmonary disease, asthma, poorly controlled diabetes, or severe peripheral arterial disease, rendering the patient unable to use non-selective beta-blockers or intolerant to the medication; 17. Receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation, or other topical routes) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study; 18. Presence of any severe or uncontrolled systemic disease, for example: 1) Significant and severely symptomatic abnormalities in rhythm, conduction, or morphology on resting ECG, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmias, or atrial fibrillation; 2) Unstable angina pectoris, congestive heart failure, chronic heart failure classified as New York Heart Association (NYHA) class >=2; 3) Any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, occurring within 6 months prior to study enrollment; 4) Poorly controlled blood pressure (systolic blood pressure >140 mmHg or 90 mmHg or <60 mmHg); 19. Participation in another clinical drug trial within 4 weeks prior to enrollment; 20. Diagnosis of another malignancy within 3 years prior to the first dose (excluding tumors cured by local treatment, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix); 21. According to the investigator's judgment, the presence of concomitant diseases that seriously endanger patient safety or affect the patient's ability to complete the study, including but not limited to hypertension uncontrollable by medication, severe diabetes, active infection, etc. Any condition that, in the opinion of the investigator, would interfere with the evaluation of the study drug or the safety of the subject or the interpretation of study results, or any other condition that makes the subject unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Disease Control Rate (DCR);Duration of Response (DOR);Progression-Free Survival (PFS);Overall Survival (OS);1-year real-world progression-free survival rate;Adverse Event;Serious Adverse Event;Treatment-Related Adverse Even; | — |
Countries
China
Contacts
Public ContactWu Fengying
Shanghai Pulmonary Hospital
Outcome results
None listed