small cell lung cancer
Conditions
Interventions
experimental group:Pembrolizumab Plus Irinotecan
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have a histologically or cytologically confirmed diagnosis of SCLC. 2. Confirmed radiological relapse within 90 days from the last day of first-line chemotherapy. 3. Have adequate tumor tissue sample to test PD-L1 immunohistochemistry. 4. Have measurable disease based on RECIST 1.1 as determined by the site. 5. Be >= 18 and = 90g/L ( no blood transfusion in 2 weeks) 2) Absolute neutrophil count (ANC) >= 1.5 x 10^9/L 3) PLT >= 80 x 10^9/L 4) Bilirubin 45 ml/min(Cockcroft-Gault Formula) 9. Be willing and able to provide written informed consent/assent for the trial. 10. Female subject of childbearing potential should have a negative urine or serum pregnancy within 7 days from registration.Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days (or longer as specified by local institutional guidelines) after the last dose of study medication. Male subjects of childbearing potential must agree to use an adequate method of contraception as outlined in Section 5.7.2- Contraception, starting with the first dose of study therapy through 120 days (or longer as specified by local institutional guidelines) after the last dose of study therapy.
Exclusion criteria
Exclusion criteria: 1. Patients who are currently participating in an interventional clinical study treatment or have received other study drugs or have been treated with a study device within 4 weeks prior to the first dose; 2. Patients who have previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs targeted at another stimulus or co-inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137); 3. Patients who have previously received systemic treatment with Chinese patent medicines with anti-lung cancer indications or immunomodulatory drugs (including thymosin, interferon, and interleukin, with the except for topical use for control of pleural effusion) within 2 weeks prior to the first dose, or major surgical treatment within 3 weeks prior to the first dose; 4. Patients who have received pulmonary radiation therapy > 30 Gy within 6 months prior to the first dose; 5. Patients who have received physical organ or blood system transplantation; 6. Patients with clinically uncontrollable pleural effusion/abdominal effusion; 7. Patients known to have severe allergic reactions to active ingredients and/or any excipients of Pembrolizumab, irinotecan and or other accessory ingredients; 8. Patients who have suffered from active autoimmune diseases requiring systemic treatment (e.g., use of drugs for remission, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) are not considered as systemic therapy; 9. Patients diagnosed as immunodeficient or receiving systemic glucocorticoid treatment or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study. Physiological doses of glucocorticoids (<= 10 mg/day prednisone or equivalent) are allowed; 10. Patients who have not fully recovered from toxicity and/or complications from any intervention (i.e., <= grade 1 or reaching baseline, excluding fatigue or hair loss) prior to initiation of treatment; 11. Patients diagnosed with other malignant tumors within 5 years prior to the first dose, with exceptions including radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ; 12. Patients with asymptomatic brain metastases. 13. Patients with a history of non-infective pneumonia requiring glucocorticoid therapy within 1 year prior to the first dose or currently suffering from interstitial lung diseases; 14. Patients with active infections requiring systemic treatment; 15. Patients known to have a history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 16. Patients with untreated active hepatitis B; Note: Hepatitis B subjects who meet the following criteria are also eligible for inclusion: Before the first dose, the HBV viral load must be <1000 copies/ml (200 IU/ml). Subjects should receive anti-HBV therapy to avoid virus reactivation during the entire study period of chemotherapeutic drug treatment. Subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-) do not need to receive prophylactic anti-HBV therapy, but close monitoring of virus reactivation is required; 17. Subjects with active HCV infection (HCV antibody positive and HCV-RNA levels above the lower limit of detection); 18. Patients who have received inoculation of live vaccines within 30 days prior to t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Safety;Progression Free Survival (PFS); | — |
Countries
China
Contacts
Public ContactJian Ni
Outcome results
None listed