small cell lung cancer
Conditions
Interventions
experimental group:Tislelizumab Combined with Prophylactic Cranial Irradiation +/- Thoracic Consolidative Radiotherapy
Sponsors
Cancer Hospital Affiliated of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Able to provide written informed consent (ICF) and able to understand and agree to comply with the study requirements and assessment schedule. 2. Male or female aged 18-75 years at the time of signing the ICF. 3. ECOG PS score of 0-1. 4. Histologically or cytologically confirmed small cell lung cancer. 5. Clinically staged as extensive-stage small cell lung cancer based on imaging evaluation. 6. Achieved complete response or partial response (according to RECIST v1.1) after 4-6 cycles of first-line treatment with tislelizumab combined with etoposide and platinum-based chemotherapy. 7. No brain metastasis or leptomeningeal metastasis as shown by cranial MRI or CT. 8. Expected Survival: Expected survival of >=3 months. 9. Adequate organ function, defined as follows: Hematological, biochemical, and organ function tests must be completed within 7 days before enrollment and meet the following criteria: a) Absolute neutrophil count (ANC) >=1.5 x 10^9/L, platelets >=100 x 10^9/L, hemoglobin >=90 g/L. b) International normalized ratio (INR) or prothrombin time (PT) =25 g/L (2.5 g/dL). f) Serum creatinine (Cr) =60 mL/min. g) Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) >=50%.
Exclusion criteria
Exclusion criteria: 1. Treatment with systemic immunostimulants (including but not limited to interferons, interleukin-2, tumor necrosis factor) within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of the study drug (previous use of cancer vaccines in prior treatments is allowed). 2. Use of any herbal medicines for cancer control within 14 days prior to the first dose of the study drug. 3. Any condition requiring systemic treatment with corticosteroids (prednisone >10 mg/day or equivalent) or other immunosuppressive drugs within 14 days prior to the first dose of the study drug. Note: Patients who have used any of the following steroid regimens may be eligible: Adrenal replacement steroids (prednisone <=10 mg/day or equivalent). Topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids with minimal systemic absorption. Short-term (<=7 days) prophylactic use of prescription corticosteroids (e.g., for treatment of contrast agent allergies) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reactions caused by contact allergens). 4. Receipt of live vaccines within <=4 weeks prior to the first dose of the study drug. Note: Seasonal influenza vaccines are generally inactivated vaccines and are allowed. Intranasal influenza vaccines are live vaccines and are not allowed. 5. Major surgery requiring general anesthesia within <=28 days prior to the first dose of the study drug. 6. Previous allogeneic stem cell transplantation or organ transplantation. 7. Clinically significant pericardial effusion. 8. Clinically uncontrolled pleural effusion or ascites requiring thoracentesis or paracentesis drainage within 2 weeks prior to randomization. 9. Active autoimmune disease or a history of autoimmune disease that may recur. Note: Patients with the following diseases are not excluded and may be further screened: Well-controlled type 1 diabetes. Hypothyroidism (controlled with thyroid hormone replacement therapy). Well-controlled celiac disease. Skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia). Any other disease not expected to recur without external triggers. 10. History of interstitial lung disease or non-infectious pneumonia or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc. 11. Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral treatment within 2 weeks prior to the first dose of the study drug, including but not limited to tuberculosis infection. 12. Any active malignancy within <=2 years prior to the first dose of the study drug, except for the specific cancer being studied and any locally recurrent cancer that has been cured (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ). 13. Untreated chronic hepatitis B patients or chronic hepatitis B virus carriers with HBV DNA =500 IU/mL (2500 copies/mL), active hepatitis C patients: Non-active HBsAg carriers, patients with stable active HBV infection after drug treatment (HBV DNA <500 IU/mL or 2500 copies/mL) may be enrolled, but must receive antiviral treatment during the study drug treatment period and continue treatment for 6 months after discontinuation of the study drug. 14. Known history of HIV infection. 15. Presence of any of the following cardiovascular risk factors: Cardiac chest pain within <=28 days prior to the first dose of the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival during Maintenance Therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intracranial Progression-free Survival, iPFS;6-Month and 12-Month Incidence of Brain Metastases;overall survival, OS;Progression-Free Survival;Safety;Potential Predictive Biomarkers;Objective Response Rate;Duration of Response;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactHui Zhu
Cancer Hospital Affiliated of Shandong First Medical University
Outcome results
None listed