limited-stage small cell lung cancer
Conditions
Interventions
experimental group:atezolizumab+carboplatin+etoposide
Sponsors
Beijing Chest Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients must be volunteered to participate in the clinical trial. Patients must sign the informed Consent form (ICF) and be willing to follow and able to complete all test procedures. 2.Histologically or cytologically confirmed stage SCLC stage T1-2N1-2M0. 3.Aged 18-75 years. 4.ECOG 0-2. 5.Expected survival >= 3 months. 6.Without prior treatments including surgery, chemotherapy, radiotherapy, and targeting treatment for small cell lung cancer. 7.Patients must have measurable disease based on Response Evaluation Criteria in Solid Tumors. 8.Patients with good physical condition and good organ function. 9.Use adequate contraception for patients of child bearing potential. 10.Patients can tolerate chemotherapy, immunotherapy, and surgery.
Exclusion criteria
Exclusion criteria: 1. Any treatment for SCLC (including chemotherapy, radiotherapy and othe anti-tumor therapy). 2. Previously use of check point inhibitor (anti-PD-1/PD-L1). 3. Interstitial pneumonia, non-infectious pneumonia and uncontrollable systemic disease, such as pulmonary fibrosis and acute pulmonary disease. 4. Severe chronic or active infection by bacteria, fungus and virus which need systemic treatment, including tuberculosis. 5. Human immunodeficiency virus (HIV) infection. 6. Active hepatitis B or hepatitis C infection. 7. Autoimmune disease for now or the one who may suffer relapse of this disease history. 8. Immunosuppressive drugs or systemic glucocorticoids are being used for immunosuppressive purposes. 9. Other disease that may harm the health of the patients defined by the investigator. 10. Major surgery or severe trauma within 4 weeks prior to the first use of the study drug. 11. Present of poorly controlled cardiac symptoms or disease, including but not limited to: (1) Heart failure with NYHA class II or above; (2) Unstable angina; (3) Myocardial infarction occurred within 6 months; (4) Clinical significance supraventricular or ventricular arrhythmias without clinical intervention or poorly controlled after clinical intervention. 12. History of allergic to monoclonal antibody, any component of atezolizumab, carboplatin and etoposide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major pathologic response, MPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease-free survival, DFS;overall survival, OS;Treatment Emergent Adverse Event, TEAE; | — |
Countries
China
Contacts
Public ContactZhe Liu
Beijing Chest Hospital, Capital Medical University
Outcome results
None listed