Extensivedisease of small cell lung cancer, ES-SCLC
Conditions
Interventions
Experimental group:AK112+Etoposide+Carboplatin
Sponsors
Jilin Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Be able and willing to provide written informed consent form. 2. 18 to 75 years old (at the time of inform consent obtained), male or female. 3. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Have a life expectancy of at least 3 months. 5. Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system). 6. Has not received systematic treatment for extensive stage small cell lung cancer in the past. Patients who have previously received radiotherapy and chemotherapy for limited stage SCLC and have had an untreatable interval of at least 6 months from the end of systemic treatment to SCLC recurrence. 7. Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator. 8. Has adequate organ function. 9. All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment. 10. Be able and willing to comply with all requirements of study participation (including all study procedures).
Exclusion criteria
Exclusion criteria: 1.Histologically or cytologically confirmed mixed SCLC and NSCLC. 2.History of prior malignancy except that basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. 3. Palliative local treatment for non-target lesions within 2 weeks before the first dose; non-specific immunomodulatory treatment (such as interleukins, interferons, thymic peptides, tumor necrosis factors, etc., excluding IL-11 used for the treatment of thrombocytopenia) within 2 weeks before the first dose; traditional Chinese herbs or proprietary Chinese medicines with anti-tumor indications within 1 week before the first dose. 4. Previously received immunotherapy, including immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy, or any treatment targeting tumor immune mechanisms; or previously received anti-angiogenesis therapy. 5.Previous unresolved toxicities from anti-tumor treatments, defined as toxicities not resolved to Grade 0 or 1 as per NCI CTCAE version 5.0 or to levels specified in the inclusion/exclusion criteria, except for toxicities such as alopecia and irreversible but non-safety impacting toxicities. 6. Imaging during the screening period shows the tumor encasing major blood vessels or significant necrosis/cavitation, and the investigator judges that participation would pose a bleeding risk. 7. History of severe bleeding tendencies or coagulation disorders; significant clinically relevant bleeding symptoms within 1 month before the first dose, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing up or expectorating = 1 teaspoon of fresh blood or small clots or only blood without sputum, participants with blood-tinged sputum are allowed), or nasal bleeding (excluding epistaxis and retronasal bleeding); receiving ongoing antiplatelet or anticoagulant therapy within 10 days before the first dose. 8. Active autoimmune disease requiring systemic treatment within the past two years (e.g., with disease-modifying drugs, corticosteroids, or immunosuppressants). Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment. 9. History or current presence of non-infectious pneumonitis/interstitial lung disease requiring systemic glucocorticoid therapy. 10.Presence of brainstem, meningeal, spinal cord metastasis, or compression. Active CNS metastatic lesions; participants previously treated for brain metastases (e.g., surgery, radiation) may be included if clinically stable for at least two weeks post-treatment (calculated from the first dose of the study drug) and have discontinued corticosteroid therapy at least seven days before the first dose; untreated, asymptomatic brain metastasis participants (i.e., no neurological symptoms, no need for corticosteroids, no single brain lesion with a long diameter > 1.5 cm, no significant perilesional edema) may be included. 11.Tumor invasion into surrounding vital organs and vessels (e.g., heart and pericardium, trachea, esophagus, aorta, superior vena cava) or at risk of esophagotracheal or esophagopleural fistula formation. 12.Presence of clinically symptomatic or drainable pleural effusion, pericardial effusion, or ascites. 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR);Time To Response (TTR);Duration of Response (DoR);Progression Free Survival (PFS);Overall Survival (OS);Safety; | — |
Countries
China
Contacts
Public ContactCheng Ying
Jilin Cancer Hospital
Outcome results
None listed