Extensive-stage small-cell lung cancer
Conditions
Interventions
Treatment Group:lurbinectedin+Ivonescimab
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Fully informed about the study and voluntarily signed a written informed consent form; 2. Male or female with age 18-75 years; 3. Histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC); 4. Failure after previous first-line immunotherapy combined with platinum-based systemic therapy; 5. ECOG PS 0-1; 6. According to RECIST v1.1, there must be at least one measurable lesion suitable for repeated and accurate measurement; 1.brain metastases cannot be considered as target lesions; 7. Having adequate bone marrow, hepatic, renal and metabolic function, meaning the functional level of the organs meets the following requirements: (1) Platelet count >=100×10^9/L; Hemoglobin (Hb) >= 90 g/L; Absolute neutrophil count (ANC) >= 1.5×10^9/L; (2) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =50 mL/min (creatinine clearance was calculated by Cockcroft_Gault formula); (6) urine protein = 3.0 g/dL; (9) international normalized ratio (INR) 50%; 8. Adverse events from prior treatments must have recovered to <= Grade 1 (NCI-CTCAE 5.0), excluding grade 2 alopecia and nonpainful peripheral sensory neuropathy; 9. Patients consent to the collection of tumor tissue and peripheral blood samples required during the screening period and throughout the course of the study, which will be utilized for relevant research purposes; 10. Women of childbearing potential(WOCBP) must have a negative serum pregnancy test before enrollment. WOCBP must use effective contraceptive measure during the trial drug treatment and for 6 months after the last administration. Male patients (with partners of WOCBP) must use effective contraceptive measure during the trial drug treatment and for 4 months after the last administration.
Exclusion criteria
Exclusion criteria: 1. The patient had a history of other tumors within 1.5 years, excluding skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma, and cervical cancer in situ. 2. History of severe bleeding tendency or coagulopathy; The presence of clinically significant hemoptysis [defined as coughing up or coughing up >=1 teaspoon (about 5ml) of blood (one time or total amount in 24 hours) or small blood clots or coughing up blood without sputum] within 1 month before the first dose, Patients with blood in sputum were allowed to be enrolled], epistaxis (excluding epistaxis and retraction of nasal bleeding), and continuous antiplatelet or anticoagulant therapy within 10 days before the first dose. 3. Imaging during the screening period showed that the tumor was surrounded by important blood vessels or had obvious necrosis or cavity, and the investigator judged that entering the study would cause bleeding risk; 4. Tumor invasion of surrounding important organs and blood vessels (such as heart and pericardium, trachea, esophagus, aorta, superior vena cava, etc.) or the risk of esophagotracheal fistula or esophagopleural fistula; 5. Symptomatic central nervous system metastases; Patients with asymptomatic brain metastases or stable symptoms after treatment of brain metastases for >=2 weeks before the first dose of treatment were eligible for participation in the study if they met all the following criteria: no metastases to the meninges, midbrain, pons, cerebellum, medulla, spinal cord, or spinal cord compression; No previous history of intracranial hemorrhage; Glucocorticoid therapy was stopped for more than 2 weeks before the first dose. There was no obvious edema around brain metastases. The maximum diameter of non-brain metastases was more than 1.5 cm. 6. History of bone marrow or stem cell transplantation; 7. Severe drug allergy or known allergy to any component of the study drug; 8. Received live vaccine within 30 days before treatment; 9. Active infection requiring systemic therapy; 10. Presence of uncontrollable pleural, pericardial or peritoneal effusion; 11. Active hepatitis B/C or HIV infection; 12. Previous history of myocarditis, cardiomyopathy, malignant arrhythmia, cardiac or other vascular stenting, angioplasty, or surgery. 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; 13. History of esophagogastric varices, severe ulcer, unhealed wound, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess or acute gastrointestinal bleeding within 6 months before the first dose of medication; 14. Any arterial thromboembolic event, NCI CTCAE version 5.0 grade 3 or higher venous thromboembolic event, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months before the first dose; 15. Systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg after treatment with oral antihypertensive drugs; 16. Evidence of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, idiopathic pneumonia, or active pneumonia on s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Overall survival;Biomarker;Median duration of response;Objective response rate;Median progression-free survival;Disease control rate; | — |
Countries
China
Contacts
Public ContactZhou Caicun
Shanghai East Hospital
Outcome results
None listed