Patients with extensive small-cell lung cancer who have not previously received systemic therapy
Conditions
Interventions
Experimental Group:Bemosubebezumab combined with anlotinib + etoposide + carboplatin sequential chest radiotherapy
Sponsors
Affiliated Hospital of Guangdong Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with extensive-stage small cell Lung cancer confirmed by pathology (according to the Veterans Administration Lung Study Group, VALG staging); 2. Has not received systemic treatment for extensive-stage small cell lung cancer in the past; 3. For patients who have previously received radiotherapy and chemotherapy for limited-stage SCLC, they must have received radical treatment and have at least a 6-month treatment-free interval from chemotherapy, radiotherapy, or the end of radiotherapy and chemotherapy to the diagnosis of extensive-stage SCLC (calculated by the end time of the last chemotherapy cycle/the end time of the last radiotherapy). 4. Only when there is a measurable lesion as defined by the RECIST 1.1 standard, the previously irradiated lesion shows clear progression after radiotherapy, and this previously irradiated lesion is not the only lesion, can the lesion be considered a measurable lesion. 5. Be between 18 and 75 years old; ECOG physical condition: 0-1 point; The expected survival period exceeds three months. 6. Normal functions of major organs, that is, meeting the following criteria: a) Blood routine test (under the condition of no blood transfusion and no use of hematopoietic stimulating factor drugs for correction within 14 days) : Hemoglobin (Hb) >=90g/L; Absolute neutrophil count (ANC) >=1.5×10^9/L; Platelet count (PLT) >=100×10^9/L; White blood cell count (WBC) >=3.0×10^9/L; b) Biochemical tests: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =50%; 7. Women of childbearing age should agree that they must use contraceptive measures (such as intrauterine devices [IUD], contraceptives or condoms) during the study period and for six months after the study ends. The serum pregnancy test must be negative within 7 days before enrollment in the study, and the subjects must be non-lactating. Male subjects who should agree to the use of contraceptive measures during the study period and within six months after the end of the study period; 8. The subjects voluntarily joined this study, signed the informed consent form and had good compliance.
Exclusion criteria
Exclusion criteria: 1. Previously used anti-angiogenic drugs such as anlotinib, apatinib, bevacizumab, or related immunotherapy drugs such as PD-1 and PD-L1; 2. Subjects with known central nervous system metastases and/or cancerous meningitis; Unless asymptomatic, or treated and stable, no imaging evidence of new brain metastases or brain metastasis expansion was found at least 2 weeks after brain metastasis treatment, and steroid or anticonvulsant drug treatment was stopped for at least 14 days before the start of the study treatment. If active or new untreated, asymptomatic CNS metastases are found in the subjects during the screening period through imaging, radiotherapy must be received or no imaging evidence of new brain metastases or brain metastasis expansion must be found for at least 2 weeks without treatment. ; 3.Within 5 years, the subject had a history or concurrent history of other malignant tumors (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 4. Those with multiple factors that affect oral medication (such as inability to swallow, after gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 5. Uncontrolled pleural effusion, pericardial effusion or ascites that requires repeated drainage; 6. Spinal cord compression that has not been cured or relieved by surgery and/or radiotherapy, or for previously diagnosed spinal cord compression, there is no clinical evidence that the disease was stable for =1 week before randomization after treatment; 7. Imaging (CT or MRI) shows that the tumor invades major blood vessels or has an unclear boundary with major blood vessels; 8. Subjects with evidence or history of bleeding tendency within 2 months prior to the first administration, regardless of the severity; There is a history of hemoptysis (defined as blood being bright red or 1/2 teaspoon) within 2 weeks before the first administration, or there are unhealed wounds, ulcers or fractures. 9. Subjects whose adverse events (excluding hair loss) caused by previous treatment have not recovered to =150 mmHg or diastolic blood pressure >=100mmHg); b) Suffering from grade >=2 myocardial ischemia or myocardial infarction, arrhythmia (including QTc>=450ms(male), QTc>= 470ms(female)) and grade >=2 congestive heart failure (New York Heart Association (NYHA) classification); c) Active or uncontrolled severe infection (>=CTC AE grade 2 infection); d) Liver cirrhosis, active hepatitis *; Active hepatitis (Reference for hepatitis B: positive HBsAg and HBV DNA detection value exceeding the upper limit of normal; reference for hepatitis C: positive HCV antibody and HCV virus titer detection value exceeding the upper limit of normal); e) Positive HIV test; f) Poor control of diabetes (fasting blood glucose (FBG) > 10mmol/L); g) Those whose urine routine test indicates urine protein >=++ and whose 24-hour urine protein q
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of relief;Disease control rate;Objective response rate;Progression-free survival (PFS) rates at 6 months and 12 months;Overall survival (OS) rates at 12 months and 18 months;Quality of life score; | — |
Countries
China
Contacts
Public ContactHualin Chen
Affiliated Hospital of Guangdong Medical University
Outcome results
None listed