small cell lung cancer
Conditions
Interventions
Cadonilimab + Surufatinib:Cadonilimab 10mg/kg Q3W + Surufatinib 300mg250mg QD
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subject must sign the written informed consent form (ICF) voluntarily. 2. Aged >=18 to = 3 months. 5. Histologically or cytologically confirmed ES-SCLC according to the Veterans Administration Lung Study Group(VALG) stage. 6. Subjects with metastatic disease who experienced disease progression following first-line platinum-based chemotherapy combined with PD-(L)1 inhibitor therapy, with =1.5×10^9/L; b. Platelet count >=100×10^9/L; c. Hemoglobin >=90 g/L. (2) Renal function: a. Serum creatinine =50 mL/min (calculated by Cockcroft-Gault formula): CrCl (mL/min) = [(140 - age) × weight (kg) × F] / [serum creatinine (mg/dL) × 72](F = 1 for males; F = 0.85 for females); b. Urine protein =28 g/L. (4) Coagulation: International Normalized Ratio (INR) and activated partial thromboplastin time (APTT) =50%. 9. Women of childbearing potential must have a negative urine or serum pregnancy test within 3 days before the first dose. If a nonsterile male subject has sexual intercourse with a female partner of childbearing potential, he must use an effective method of contraception from the start of screening until Day 120 after the last dose. 10. Subjects must be willing and able to comply with the scheduled visits, treatment regimens, laboratory tests, and other requirements in the study.
Exclusion criteria
Exclusion criteria: 1. Malignancies other than SCLC within 3 years prior to enrollment. However, subjects with other malignancies that have been cured are eligible, such as basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, cervical or breast carcinoma in situ. 2. Subjects received the last systemic treatment (chemotherapy, immunotherapy, biologics) within 3 weeks prior to the initial administration. Palliative local treatment was applied to non-target lesions within 2 weeks prior to the initial administration. Non-specific immunomodulatory therapy(e.g., interleukins, interferons, thymosin, TNF-a; excluding IL-11 for thrombocytopenia) was administered within 2 weeks prior to the initial administration. Chinese herbal medicine with anti-tumor indications was taken within 2 weeks prior to the initial administration. 3. Previously received non-PD-(L)1 inhibitors, including immune checkpoint inhibitors (e.g. anti-CTLA-4 antibodies), immune checkpoint agonists (e.g. ICOS, CD40, CD137, GITR, OX40 antibodies), cell therapy, or any other treatments aimed at tumor immune mechanisms. 4. Previously treated with anti-VEGF/VEGFR drugs, including bevacizumab, anlotinib, apatinib, endostar, and surufatinib. 5. Subjects whose imaging at screening shows that the tumor encircles important blood vessels or has significant necrosis and cavitation, and the subjects'participation is associated with a risk of hemorrhage. 6. Tumor invasion of surrounding vital organs and blood vessels (e.g., heart/pericardium, trachea, esophagus, aorta, superior vena cava) or high risk of esophageal-tracheal/pleural fistula. 7. History of esophagogastric varices, severe ulcers, non-healing wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the initial dosing. 8. Subjects with grade 3 or higher immune-related adverse events (excluding endocrine-related events) resulting from previous immunotherapy, irAE leading to permanent treatment discontinuation, grade 2 immune-related cardiac toxicity or any grade neurological or ocular irAE. Unresolved irAEs from prior immunotherapy (>Grade 1 at screening). Exception: Asymptomatic endocrine irAEs >= Grade 2 stabilized with hormone replacement therapy. 9. Subjects requiring non-glucocorticoid immunosuppressive agents for adverse events, or experiencing recurrent adverse events during previous immunotherapy necessitating systemic glucocorticoid re-administration. 10. Subjects who had active autoimmune disease that required systemic treatment (disease-modifying agents, corticosteroids, immunosuppressants) in the past two years. Exclusion: Physiologic hormone replacement (thyroxine, insulin, adrenal/pituitary replacement). 11. Subjects with prior history of non-infectious pneumonitis/interstitial lung disease requiring systemic glucocorticoid therapy or with non-infectious pneumonitis at present. 12. Presence of metastases to brainstem, meninges and spinal cord, or spinal cord compression. Active CNS metastases. Exceptions: treated brain metastases (surgery/radiotherapy) stable >= 2 weeks with corticosteroid-free for 7 days pre-dosing; untreated asymptomatic brain metastases. 13. Subjects with pleural effusion, pericardial effusion, or ascites that are clinically symptomatic or require drainage. 14. Administration of live vaccines within 4 weeks prior to the initial dosing, or planned administration of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR);Progression Free Survival (PFS);Duration of Response (DOR);Overall survial (OS);Adverse Events; | — |
Countries
China
Contacts
Public ContactYi Hu
Chinese PLA General Hospital
Outcome results
None listed