Small cell lung cancer
Conditions
Interventions
treatment arm:Sintilimab + Surufatinib
Sintilimab 200mg, Q3W
Surufatinib 250 mg,po,QD
until PD, intolerable toxicity, death
Sponsors
?The 980th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army?
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria for enrollment: 1. Pathologically or cytologically confirmed small cell lung cancer (SCLC) classified as extensive-stage according to the Veterans Administration Lung Cancer Staging System, and deemed unsuitable for localized therapy; 2. Disease progression after at least one prior line of systemic therapy; 3. At least one measurable lesion meeting the following criteria per Response Evaluation Criteria in Solid Tumors (RECIST 1.1): (1) Lesion diameter >=20 mm by conventional techniques or >=10 mm by spiral CT; (2) PET-CT is acceptable for disease progression assessment; (3) Ultrasound is not permitted for lesion measurement. 4. Prior radiotherapy is allowed if: (1) Radiation fields cover =4 weeks before enrollment, with resolved acute toxicities; (4) Lesions within irradiated fields cannot be target lesions unless documented progression post-radiation. 5. Prior surgery is permitted if: (1) Full recovery confirmed by the investigator; (2) Surgery completed >=4 weeks before enrollment. 6. Age18-75 years; 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0–2; 8. Estimated life expectancy >12 weeks; 9. Adequate organ function defined as; (1) Bone marrow reserve: 1). Absolute neutrophil count (ANC) >=1.5×10^9/L; 2). Platelets (PLT) >=100×10^9/L; 3). Hemoglobin (Hb) >=90 g/L. (2) Liver function: 1). Bilirubin =2+, 24-hour urinary protein must be <1 g. 10. Blood pressure control with systolic BP =160 mmHg and diastolic BP =90 mmHg within 7 days before study treatment. 11. Signed informed consent form. 12. Contraception requirements: 13. Female patients: Surgically sterile, postmenopausal, or agreeing to use medically approved contraception (e.g., IUD, oral contraceptives, barrier methods) during treatment and for 6 months after treatment end. Negative serum/urine pregnancy test within 7 days before enrollment; non-lactating. 14. Male patients: Surgically sterile or agreeing to use medically approved contraception during treatment and for 6 months after treatment end.
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: 1. Confirmed or suspected brain metastasis; (1) Patients with suspected brain metastasis must undergo brain CT/MRI prior to enrollment; (2) Patients with prior brain metastasis history may enroll only if they have completed treatment (e.g., surgery/radiotherapy) and do not require corticosteroids; (3) Asymptomatic brain metastasis requires investigator evaluation for eligibility; 2. Leptomeningeal metastasis. 3. Prior therapy with: (1) Anti-PD-1/PD-L1 antibodies (e.g., pembrolizumab) (2) Anti-CTLA-4 antibodies (e.g., ipilimumab) (3) Antiangiogenic agents (e.g., bevacizumab). 4. Concurrent antitumor therapy (chemotherapy, targeted therapy, or immunotherapy). 5. Active autoimmune diseases (congenital/acquired), including: (1) Interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, or nephritis. (2) Exceptions: Vitiligo;Childhood asthma resolved without intervention;Hypothyroidism controlled with hormone replacement;Type 1 diabetes managed with insulin. 6. Interstitial lung disease (ILD). 7. Bleeding diathesis, including: (1) Acute GI bleeding (2) Clinically significant epistaxis (excluding minor nosebleeds) (3) Hemoptysis (4) Coagulopathies. 8. Hemoptysis within 4 weeks before treatment (defined as >=1 teaspoon of fresh blood/clots), excluding blood-tinged sputum; 9. Use of the following within 10 days before enrollment: (1) Warfarin/heparin; (2) Aspirin (>325 mg/day); (3) Antiplatelet agents (dipyridamole, ticlopidine, clopidogrel, cilostazol). 10. Uncontrolled comorbidities that compromise patient safety or study completion per investigator assessment. 11. Pregnancy or lactation. 12. Other malignancies, except: (1) Cervical carcinoma in situ (2) Papillary thyroid carcinoma (3) Non-melanomatous skin cancer (4) Malignancies diagnosed >5 years ago with no recurrence (5) Low-grade (Gleason score <=6) localized prostate cancer regardless of diagnosis timing. 13. Hypersensitivity to any component of the study drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease control rate;Safety; | — |
Countries
China
Contacts
Public ContactLiangang Chen
?The 980th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army?
Outcome results
None listed