Small cell Lung cancer
Conditions
Interventions
A:ak112+Albumin-bound paclitaxel:Single-agent AK112 maintenance therapy was entered after 4-6 cycles of AK112 (ivocimab, 20mg/kg, intravenous infusion, Q3W) in combination with nab-paclitaxel,Until th
B:Albumin-bound paclitaxel:Albumin-paclitaxel monotherapy for 4 to 6 cycles, or until the following occurs: proven disease progression, intolerable toxicity, or other causes specified in the protocol
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily provide written informed consent. 2. The age of 18 and 75 years of age or less or more. 3.Eastern Cooperative Oncology (ECOG) performance status 0 or 1. 4. Expected survival time =3 months. 5. Histologically or cytologically confirmed ES-SCLC according to the American Legion Lung Cancer Association VALG staging system. 6. At most one prior systemic regimen. 7. At least one measurable lesion according to RECIST v1.1. 8. Good organ function was determined by the following requirements (examination results within 14 days before starting study treatment were required) : a) Hematology (no blood component and cell growth factor support therapy within 7 days before starting study treatment) : i. neutrophils absolute ANC acuity 1.5 x 10^9 / L (1500 cells/mm3) ii. Platelet count = 100 × 10^9/L (100,000/mm3) iii. Hemoglobin = 90 g/L b) Kidney: i. Serum creatinine = 1.5 × ULN ii. The urine protein & lt <2+ or 24-hour (h) urinary protein quantification < 1.0 g c) Liver: i. Total serum bilirubin (TBil) = 1.5 × ULN ii.AST and ALT = 2.5× ULN or = 5×ULN for subjects with liver metastases iii. Serum albumin (ALB) =28 g/L d) Coagulation: international normalized ratio (INR) and activated partial thromboplastin time (APTT) = 1.5 × ULN 9. Female subjects of childbearing potential must undergo a urine or serum pregnancy test within 3 days before the first dose of medication (if the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test should be performed, and the result is negative). As with fertile women subjects and unneutered male partner sex, the participants must begin screening acceptable contraceptive methods, and must be agreed to at the end of the study drug time within 120 days after the administration continues to use the contraceptive method, Discontinuation of contraception after this time point should be discussed with the investigator. 10. If an unsterilized male subject has sex with a fertile female partner, the subject must use an effective method of contraception from the start of screening until 120 days after the last dose of medication Discontinuation of contraception after this time point should be discussed with the investigator. 11. Participants were willing and able to comply with the scheduled visits, treatment protocols, laboratory tests, and other requirements of the study.
Exclusion criteria
Exclusion criteria: 1. In addition to the small cell lung cancer, the participants in the group of the first five years with other malignant tumours. Subjects with other malignancies that had been cured by local treatment, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, other carcinoma in situ, were not excluded. 2. Enroll in another clinical study at the same time, unless it is an observational, noninterventional clinical study or a follow-up period of an interventional study. 3. Prior antiangiogenic or antimicrotubule therapy. 4. Imaging during the screening period showed tumor invasion or significant necrosis or cavitation, and the investigator judged that entry into the study would cause bleeding risk. 5. In the past two years with need systemic treatment of active autoimmune disease (such as using the better drugs, corticosteroids, immunosuppressive therapy). Thyroid hormone replacement therapy (such as, insulin, or for adrenal or pituitary insufficiency of physiology sex steroids replacement therapy) don't think that is a kind of systemic treatment. 6. Previous history of noninfectious pneumonia/interstitial lung disease requiring systemic glucocorticoids or current noninfectious pneumonia. 7. Presence of brain stem, meningeal metastasis, spinal cord metastasis or compression. 8. There is active central nervous system (CNS) metastatic lesions.Subjects who had previously been treated for brain metastases (e.g., surgery, radiotherapy) were allowed if they were clinically stable for at least two weeks after treatment (calculated from the time of the first administration of the study drug) and if corticosteroids were discontinued 7 days before the administration of the study drug. "Untreated, asymptomatic subjects with brain metastases (i.e., no neurological symptoms, no need for corticosteroids, no length > of any brain metastases>1.5 cm, with no apparent brain metastases surrounding edema) may enter group. 9. Subject with uncontrolled effusions. 10. Current uncontrolled coexisting medical conditions, including but not limited to decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorder, severe active peptic ulcer disease, or gastritis, or mental illness/social condition that would limit compliance with study requirements or affect the participant's ability to provide written informed consent. 11. Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia. The presence of unstable angina, myocardial infarction, congestive heart failure (New York Heart Association functional class 2 or higher), or vascular disease (e.g., aortic aneurysm at risk for rupture) that required hospitalization within 12 months before the first dose of the study drug or other cardiac impairment (e.g., uncontrolled arrhythmias, myocardial ischemia) that could affect the safety evaluation of the study drug. The patient had a history of esophagogastric varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months before the first dose of medication. Any arterial thromboembolic event, venous thromboembolic event of NCI CTCAE version 5.0 or higher, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy occurred within 6 months before the first dose of dose. An acute exacerbation of chronic obstructive pulmonary disease occurred w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival period; PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Overall survival;Duration of response;quality of Life;Patient Reported Outcome;Safety; | — |
Countries
China
Contacts
Public ContactZhou Jin
Sichuan Cancer Hospital
Outcome results
None listed