lung cancer
Conditions
Interventions
Case series:IBI308
Sponsors
Shandong Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All subjects were required to sign an informed consent form (Inform consent form, ICF); 2. Aged 18 to 70 years old; 3. years old) before starting the study. Histologically or cytologically confirmed SCLC; 4. According to the (Veterans Administration Lung Study Group, VALG) staging of the American Legionnairesundefined Lung Cancer Association, ED-SCLC; 5. Patients must have received 4-6 cycles of platinum combined with etoposide first-line chemotherapy for ED-SCLC, and objective imaging was complete remission (CR), partial remission (PR) and disease stable (SD); 6. The positive expression of PD-L1 (PD-L1 > 1 SP142PD-L1 immunocytochemical antibody) was detected by IHC in the local laboratory using previously archived or freshly obtained tumor tissues or biopsy specimens; 7. ECOG PS 0 / 1; 8. The estimated survival time is more than 8 weeks; 9. Male subjects, as well as women of childbearing age, must use contraception within 24 weeks of starting the first dose of the drug to the last drug; 10. The functions of the organs meet the following requirements: (1) Blood routine examination: leukocyte count (white blood cell, WBC) = 3.0 × 10^9/L, absolute neutrophil count (absolute neutrophil count, ANC) = 1.5×10^9/L, platelet (platelet, PLT) = 100×10^9/L; Hemoglobin content (hemoglobin, HGB) = 9.0 g/dL (2) liver function: aspartate aminotransferase (aspartate transferase, AST) = 2.5x ULN; alanine hepatic aminotransferase (alanine aminotransferase, ALT) = 2.5x ULN, liver metastases ALT and AST < 5x ULN; Serum total bilirubin (total bilirubin, TBIL) = 1.5 x ULN (excluding Gilbert syndrome total bilirubin < 3. 0 mg/dL, albumin (albumin, ALB) = 3 g/dL (3) renal function: serum creatinine = 1. 5x ULN or creatinine clearance rate (creatinine clearance rate, CrCl) = 40 mL/minute (using Cockcroft/Gault formula). (4) coagulant function: international standardized ratio (international normalized ratio, INR) = 1.5xULN, activated partial thromboplastin time (activated partial thromboplastin time, APTT) = 1.5 xULN; 11. Patients who begin the study require no less than 21 days of first-line chemotherapy (day one) from the last cycle, but no more than 42 days.
Exclusion criteria
Exclusion criteria: 1. mixed SCLC and NSCLC. confirmed by histology or cytology; 2. have been treated with antitumor virus in the past. Any previous T cell costimulation or immunological checkpoint therapy including, but not limited to, cytotoxic T lymphocyte associated antigen-4 (cytotoxic T lymphocyte-associated antigen-4,CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other drugs targeting T cells; 3. active brain metastasis or meningeal metastasis. The following conditions are required for the treatment of brain metastases to be admitted to the group. Progression of patients who have been allowed to receive prophylactic brain irradiation for (PCI): treatment = 4 weeks without MRI proof; completion of treatment = 7 days before admission to the group; 4. Previous radiotherapy must end at least 4 weeks before the study enters the group. The patient must have recovered from the acute toxicity of the treatment; 5. The third space effusion with clinical symptoms, such as pericardial effusion, pleural effusion, and peritoneal effusion that are still beyond control by water pumping or other treatment; 6. active, known or suspected autoimmune disease (cf. Annex IV). Conditions that allow vitiligo, type I diabetes, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement therapy alone, or absence of external stimuli may be admitted to the group; 7. Corticosteroids (prednisone or equivalent dose) or other immunosuppressants were used within 14 days before entering the group. Inhaled or locally used steroids and adrenal replacement steroids are allowed in the absence of active autoimmune diseases; 8. (interstitial pneumonia, ILD) undefineds disease and drug-induced pneumonia were studied in 9 subjects who had been vaccinated or planned to be vaccinated alive within 4 weeks before entering the study group; 9. interstitial pneumonia (interstitial pneumonia, ILD) disease, drug-induced pneumonia, radiation pneumonia requiring steroid treatment or active pneumonia with clinical symptoms; 10. subjects with active pulmonary tuberculosis (tuberculosis, TB) or history of active pulmonary tuberculosis infection within 48 weeks before screening, whether or not treated; 11. in addition to alopecia and fatigue, other toxicities due to previous antitumor therapy need to be recovered to CTCAE4.03 = 1 before the first dose study. Other unsolvable and persistent sequelae resulting from previous antitumor therapy, such as neurotoxicity due to platinum based therapy, are allowed to enter the group; 12. the study had the following history in the first 24 weeks: gastrointestinal ulcer, gastrointestinal perforation, corrosive esophagitis or gastritis, inflammatory bowel disease or diverticulitis, abdominal fistula, tracheoesophageal fistula or intraperitoneal abscess; 13. The study had the following history during the first 24 weeks: gastrointestinal ulcer, gastrointestinal perforation, corrosive esophagitis or gastritis, inflammatory bowel disease or diverticulitis, abdominal fistula, tracheoesophageal fistula or intraperitoneal abscess; 14. It is known that severe allergic reactions to any of the monoclonal antibodies have occurred; 15. years before entering the group with other malignant tumors that can be adequately treated for cervical carcinoma in situ, basal or squamous cell skin cancer, and local prostate cancer after radical surgery. With the exception of ductal carcinoma in situ after radical mastectomy; 16. known men
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
China
Contacts
Public ContactZhehai Wang
Shandong Cancer Hospital
Outcome results
None listed