Surufatinib Combined With Serplulimab Plus Chemotherapy in the Treatment of Extensive-stage Small Cell Lung Cancer

Launched by FUJIAN CANCER HOSPITAL · May 20, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients with extensive-stage small cell lung cancer (ES-SCLC), which is a type of lung cancer that has spread beyond the lungs. The researchers want to see how effective and safe a combination of three treatments—Surufatinib, Serplulimab, and chemotherapy—can be for patients starting their treatment. The trial will also explore using Surufatinib and Serplulimab as maintenance therapy after the initial treatment.

To participate in this trial, you need to be between 18 and 75 years old, have a confirmed diagnosis of ES-SCLC, and be expected to live for at least three more months. You should not have received any prior treatment for this cancer, and your major organs need to be functioning well. However, there are some conditions that would exclude you from the trial, such as having uncontrolled high blood pressure, certain heart issues, or active severe infections. If you join the trial, you will be closely monitored by healthcare professionals throughout the treatment process to ensure your safety and to assess how well the treatment is working.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients must have the ability to understand and voluntarily sign informed consent;
• • 2. Age: 18-75 years old;
• • 3. Expected survival period ≥ 3 months;
• • 4. Histologically or cytologically diagnosed with ES-SCLC (Combined small cell lung carcinoma excepted);
• • 5. No prior systemic therapy for ES-SCLC;
• • 6. According to the RECIST 1.1 standard, the patient has at least one target lesion with a measurable diameter;
• • 7. ECOG PS: 0-1;
• • 8. Major organs are functioning well;
• • 9. The urine or serum pregnancy test results of premenopausal women were negative.
• Exclusion Criteria:
• • 1. Patients with symptomatic brain metastases;
• • 2. People with hypertension who cannot be well controlled by double antihypertensive drug (systolic blood pressure≥140 mmHg, diastolic blood pressure≥90 mmHg);
• • 3. Urine routine test showed urine protein ≥++ and confirmed 24-hour urine protein quantification\>1.0g;
• • 4. Cardiovascular disease history: congestive heart failure\> New York Heart Association (NYHA) standard II, patients with active coronary artery disease (those with myocardial infarction 6 months before enrollment can be enrolled), arrhythmia requiring treatment;
• • 5. Active severe clinical infections (\>NCI-CTCAE 5.0 version 2 infection criteria), including tuberculosis (clinical evaluation, including clinical history, physical examination, imaging findings and TB examination in line with local clinical practice), hepatitis B (known HBV Surface antigen \[HbsAg\] positive), hepatitis C or human immunodeficiency virus (HIV 1/2 antibody positive);Patients who have previously had HBV infection or have been cured (defined as the presence of hepatitis B core IgG antibodies and the absence of HBsAg) are eligible. Hepatitis C virus (HCV) antibody-positive patients are only eligible if the HCV RNA polymerase chain reaction is negative.
• • 6. Patients with bleeding tendency or coagulation disorders;
• • 7. In the past 2 years, there are active autoimmune diseases that require systemic treatment (such as corticosteroids or immunosuppressive drugs), and related alternative treatments (such as thyroxine, insulin, or physiological corticosteroid replacement for renal or pituitary insufficiency) are allowed treatment);
• • 8. Patients who are pregnant or breastfeeding;
• • 9. Allergy to any of the drugs in the study;
• • 10. Imaging (CT or MRI) shows that the tumor invades or is poorly demarcated from large vessels;
• • 11. Researchers think it is inappropriate to participate in this trial.