Small cell lung cancer
Conditions
Interventions
Group of sulfatinib :None
Group of cadonilimab:None
Group of sulfatinib combined with cadonilimab:None
Group of etoposide combined with cisplatin:None
Sponsors
The Second Hospital of Dalian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)Subjects voluntarily join this study and sign informed consent, compliance, and cooperate with follow-up; (2)Histologically or cytologically confirmed ES-SCLC according to the American Veterans Lung Cancer Society VALG stage: (3)Subjects who have not previously received systemic therapy for extensive stage small cell lung cancer; or subjects who have previously received radical chemoradiotherapy for limited stage small cell lung cancer, but whose disease progression occurs more than 6 months; (4)Subjects aged 18-75 years (including 18 and 75 years), male or female; (5)Eastern Cooperative Oncology Group (ECOG) performance status score 0-1; (6)Expected survival = 12 weeks; (7)At least 1 measurable lesion according to RECISTv1.1, and the lesion is suitable for repeated accurate measurement; brain metastases cannot be used as target lesions; (8)Subjects need to provide tumor tissue samples for exploratory assessment of the correlation between PD-L1 expression (CPS) in tumor samples and efficacy, About 5 unstained FFPE pathological sections (preferably newly obtained tumor tissue samples) archived or freshly obtained within 3 months prior to the first dose.Tumor lesions obtained for fresh tissue biopsy should not be considered RECISTv1.1 target lesions unless they are the only measurable lesions.If archival tumor tissue samples are not available within 3 months, biopsy may increase the risk to the subject as judged by the investigator, and archival tumor tissue samples beyond 3 months are allowed to be collected with the consent of the medical monitor.If 5 pathological sections cannot be provided, some or all pathological sections can be exempted with the approval of the medical monitor; (9)Good organ function (the test results within 14 days before the start of study treatment are required) is determined by the following requirements, and the main organ and bone marrow function are basically normal (no blood components or cell growth factors are used within 28 days before enrollment): 1) blood routine: white blood cells = 4.0 × 109/L, neutrophils = 1.5 × 109/L, platelets = 100 × 109/L, hemoglobin = 90 g/L; 2) international normalized ratio (INR) = 1.5 × upper limit of normal (ULN), and activated partial thromboplastin time (APTT) = 1.5 × ULN; 3) liver function: total bilirubin = 1.5 × ULN; ALT/AST/ALP = 2.5 × ULN in the absence of liver metastasis; ALT/AST/ALP = 5 × ULN in the presence of liver metastasis; serum albumin (ALB) = 28 g/L; 4) Renal function: serum creatinine = 1.5 × ULN or creatinine clearance (ClCr) = 50 mL/min; 5) normal cardiac function, left ventricular ejection fraction (LVEF) = 50% measured by two-dimensional echocardiography; (10) Female subjects of childbearing potential must have a urine or serum pregnancy test within 3 days before the first dose (if the urine pregnancy test results cannot be confirmed as negative, serum pregnancy test is required, based on the serum pregnancy results), and the results are negative.If a female subject of childbearing potential has sex with a nonsterilized male partner, the subject must use an acceptable method of contraception from Screening and must agree to continue using the method of contraception for 120 days after the last dose of study drug; discussion should be held with the investigator as to whether contraception should be discontinued after this time point; (11)If a nonsterilized male subject has sex with a female partner of childbearing potential, the subj
Exclusion criteria
Exclusion criteria: (1)Patients with non-small cell lung cancer (including mixed small cell lung cancer and non-small cell lung cancer); (2)Patients allergic to sovatinib, carnitinib; (3)Patients with other malignancies within 5 years before enrollment except small cell lung cancer. Subjects with other malignancies that have been cured by local therapy, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ, are not excluded. (4)Patients enrolled in another clinical study at the same time, unless it is an observational, non-interventional clinical study or follow-up period of interventional study; (5)Patients with current central nervous system (CNS) metastasis or previous symptoms of brain metastasis and control time less than 2 months; (6)Brainstem, meningeal metastasis, spinal cord metastasis or compression; (7)Active central nervous system (CNS) metastases; subjects who have previously treated brain metastases (such as surgery, radiotherapy) are allowed to be enrolled if clinically stable for at least two weeks after treatment (calculated from the first dose of study drug), and corticosteroids are discontinued 7 days before study drug administration; untreated, asymptomatic subjects with brain metastases (i.e., no neurological symptoms, no need for corticosteroids, no long diameter of any brain metastases > 1.5 cm, no significant edema around brain metastases); (8)Palliative local treatment for non-target lesions within 2 weeks before the first dose; Unspecific immunomodulatory therapy (such as interleukin, interferon, thymosin, tumor necrosis factor, etc., excluding IL-11 for the treatment of thrombocytopenia) within 2 weeks before the first dose; Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 1 week before the first dose; (9)Previous immunotherapy,Including immune checkpoint inhibitors (such as anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA- 4 antibody, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibody, etc.), immune cell therapy and other treatments aimed at the mechanism of tumor immunity; (10)Patients currently have any disease or state affecting drug absorption, or patients cannot take oral sovatinib; (11)Taking other strong inducers or strong inhibitors of CYP3A4 within 2 weeks before the first study medication; (12)Eceiving any surgery (except biopsy) or invasive treatment or operation within 4 weeks before enrollment and the surgical incision is not completely healed (except intravenous catheterization, puncture drainage, etc.); (13)Pleural effusion, pericardial effusion or ascites, causing respiratory syndrome (= CTCAE grade 2 dyspnea); (14)Tumor invaded the surrounding important organs and blood vessels (such as heart and pericardium, trachea, esophagus, aorta, superior vena cava, etc.) or there is a risk of esophagotracheal fistula or esophagopleural fistula; (15)The investigator judged clinically significant electrolyte abnormalities; (16)Patients with uncontrolled hypertension, defined as: patients with hypertension and can not be well controlled by antihypertensive drug treatment (systolic blood pressure = 150 mmHg, diastolic blood pressure = 100 mmHg); (17)Urine routine showed urine protein = 2 +, and 24-hour urine protein > 1.0 g; (18)Patients with active gastric and duodenal ulcer, ulcerative colitis and other gastrointestinal diseases or unresected tumors have active bl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactChen Jun
The Second Hospital of Dalian Medical University
Outcome results
None listed