irinotecan liposome (ii) or etoposide combined with adebrelimab and carboplatin in the treatment of es-sclc

Conditions: Small Cell Lung Cancer Extensive Stage

Summary: this study is a prospective, randomized, parallel, multicenter phase ii study aimed at evaluating the efficacy and safety of irinotecan liposome (ii) or etoposide combined with adebrelimab and carboplatin as first-line treatment for extensive stage small cell lung cancer. the primary endpoint of the study was the 1-year overall survival rate.


Eligibility criteria:
inclusion criteria: * pathologically confirmed small cell lung cancer (sclc), staged as extensive-stage sclc (es-sclc) according to the valg staging system; * no prior systemic treatment received; * at least a 6-month interval between the last treatment (radiation therapy and chemotherapy) and diagnosis of extensive-stage sclc; * showing at least one target lesion (recist 1.1) that has not been previously irradiated; * male or female patients aged ≥18 and ≤70 years; * ecog performance status (ps) score of 0 or 1; * life expectancy of ≥12 weeks; * adequate organ function: (1) hematologic: wbc ≥ 3.0 × 10⁹/l, anc ≥ 1.5 × 10⁹/l, plt ≥ 100 × 10⁹/l, hgb ≥ 9.0 g/dl.(2) hepatic function: ast ≤ 2.5 × uln, alt ≤ 2.5 × uln, liver metastases allowed if alt and ast ≤ 5 × uln, tbil ≤ 1.5 × uln (except for gilbert's syndrome, where total bilirubin ≤ 3.0 mg/dl),(3) renal function: cr ≤ 1.5 × uln or crcl ≥ 50 ml/min, (4) coagulation: inr ≤ 1.5 × uln, aptt ≤ 1.5 × uln; * agreement to use an appropriate contraceptive method from the first dose of the study treatment until 6 months after the last dose of the study treatment. women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment; * the patient must have fully understood the study and voluntarily consent to participate by signing the informed consent form (icf). exclusion criteria: * histologically or cytologically confirmed mixed small cell lung cancer (sclc) and non-small cell lung cancer (nsclc); * previous treatment with immune checkpoint inhibitors, or treatment with irinotecan or other dna topoisomerase inhibitors; * use of a strong cyp3a4 inducer within 2 weeks prior to the first dose of the investigational drug, or a strong cyp3a4 inhibitor or ugt1a1 inhibitor within 1 week prior to the first dose; * presence of clinically symptomatic brain metastasis, leptomeningeal metastasis, or spinal cord compression; * hematologic disorders, including but not limited to lymphoma, acute or chronic leukemia, multiple myeloma, aplastic anemia, myelodysplastic syndrome, etc; * clinically symptomatic third-space fluid accumulation, such as pericardial effusion, pleural effusion, or ascites that cannot be controlled by drainage or other treatments; * active, known, or suspected autoimmune disease; * use of corticosteroids (doses\> 10 mg/day of prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose of the study drug; * receipt of live vaccines or planned vaccination with a live vaccine within 4 weeks prior to the first dose of the study drug; * interstitial lung disease, drug-induced pneumonia, radiation-induced pneumonia requiring steroid treatment, or clinically symptomatic active pneumonia, or severe pulmonary dysfunction; * active tuberculosis or a history of active tuberculosis within 48 weeks prior to screening, regardless of whether it was treated; * any toxicity from previous anticancer therapy, that has not resolved to grade ≤1 (according to ctcae v5.0) prior to the first dose of the investigational drug; * underwent a minor surgery (including catheter placement) within 48 hours prior to the first dose of the study drug; * presence of uncontrolled cardiovascular symptoms or diseases; * hypersensitivity to the investigational drug or its excipients; * a history of any other malignancy within 5 years prior to the first dose of the study drug, except for adequately treated non-melanoma skin cancer or in situ carcinoma; * a history of psychiatric disorders, alcohol abuse, drug abuse, or substance misuse; * hbsag-positive and hbv dna levels exceeding the upper limit of normal, or hcv-positive (hcv rna or hcv ab indicating acute or chronic infection); a history of hiv-positive status or acquired immunodeficiency syndrome (aids); * received any other investigational drug or participated in another interventional clinical trial within 4 weeks prior to signing the informed consent form (icf); * a history of allogeneic bone marrow transplantation or solid organ transplantation; * any other factors as determined by the investigator.

Keywords: es-sclc extensive stage-small cell lung cancer adebrelimab irinotecan liposome (ii) zhou chengzhi