small cell lung cancer
Conditions
Interventions
Group A:Adebrelimab combined with chemotherapy synchronous LDRT
Group B:Adebrelimab combined with chemotherapy
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Participants aged 18 to 75 years, regardless of gender; 2. ECOG Performance Status (PS) score of 0-1; 3. Expected survival duration of no less than 8 weeks; 4. Histologically or cytologically confirmed extensive small cell lung cancer (according to the VALG staging system); 5. Subjects must not have received systemic therapy or radical radiotherapy for extensive SCLC prior to enrollment. 6. Presence of at least one radiation-naive measurable lesion according to RESCIST1.1; 7. Normal function of major organs and bone marrow; 8. The subject or his/her partner must be of childbearing potential and have had a negative serum pregnancy test within 7 days before the trial and be willing to use a highly effective contraceptive during the study and for 24 weeks after the last dose of the trial drug; 9. The subjects voluntarily participated in the study and signed the informed consent form. The compliance was good and the follow-up was required according to the protocol.
Exclusion criteria
Exclusion criteria: 1. Tissue classifications of mixed small cell lung cancer and non-small cell lung cancer; 2. Patients who have undergone major surgical procedures within 28 days prior to the initial administration of the study drug, or those planning to undergo major surgery during the study period (as determined by the investigator); 3. Receipt of live attenuated vaccines within 28 days before the first dose or planned for the duration of the study; 4. Participation in another clinical trial within 28 days preceding initial dosing, involving any experimental agents; 5. History of receiving chest radiotherapy or plans for intensive chest radiotherapy prior to systemic therapy; 6. Any previous T-cell co-stimulation or immune checkpoint therapies administered; 7. Documented history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 8. Active autoimmune disease requiring systemic therapy within 2 years before the first dose or a history of autoimmune disease with expected relapse. Alternative therapies were not considered systemic treatments; 9. Have innate or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection; 10. Active viral hepatitis B or C; Active TB or currently receiving anti-TB treatment; 11. Corticosteroid (>10mg/ day of prednisone or equivalent) is required within 14 days before the first dose of trial drug Amount of the same hormone) or other immunosuppressive agents in systemically treated subjects; 12. A history of noninfectious pneumonia requiring glucocorticoid therapy within 1 year before the first dose or a current interstitial lung disease; 13. Evidence of past or current severe impairment of lung function; 14. Severe myocardial ischemia or myocardial infarction and uncontrolled arrhythmia (including QTc interval prolongation); 15. Poorly controlled hypertension; 16. Arterial/venous thrombotic events occurred within 6 months before the first dose; 17. Urine routine showed urine protein = (++), or 24-hour urine protein = 1.0g; 18. Severe active or uncontrolled infection (=CTC AE grade 2 infection), including fever of unknown origin; 19. No recovery of toxicity from previous antineoplastic therapy to NCI-CTCAE version 5.0 grade 0 or 1 (except alopecia); 20. Symptomatic untreated or actively progressing central nervous system (CNS) metastases confirmed by imaging; 21. Spinal cord compression failed to be relieved or poorly controlled by surgery and/or radiotherapy; 22. Other malignant tumors in the past 5 years; 23. The third space effusion with clinical symptoms needs repeated drainage; 24. Pregnant or lactating women; Patients of childbearing potential who are unwilling or unable to use effective contraception; 25. Allergy or intolerance to the study drug or its excipients; 26. Persons with a history of psychotropic substance abuse and inability to quit, mental disorders, alcohol, drug or substance abuse; 27. The investigator considers that there are any conditions that may harm the subject or cause the subject to be unable to meet or perform the requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival by Blinded Independent Central Review (BICR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression free surviva 2;Objective Response Rate;Disease Control Rate;Duration of Response;6-month/12-month PFS rate;1-year/2-year OS rate;Post Progression Survival;Safaty; | — |
Countries
China
Contacts
Public ContactYou Lu
West China Hospital
Outcome results
None listed