LCNEC
Conditions
Interventions
Experimental group:Serplulimab Injection
Sponsors
Jilin Provincial Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.The subjects understood the trial process, voluntarily signed the informed consent form, and agreed to participate in the study. 2.Male or female aged=18 years at the time of signing the ICF. 3.Histologically or cytologically diagnosed with Locally advanced / metastatic LCNEC(According to the The 8th edition of the TNM stage in lung cancer of International Alliance Against Cancer and the American Joint Committee on Cancer (AJCC) Mixed LCNEC patients were eligible for enrollment if the LCNEC component was =50%). 4.No prior systemic therapy for LCNEC (Those who relapse=6 months after radical chemoradiation or adjuvant chemotherapy may be enrolled). 5.An ECOG PS score of 0 to 2. 6.At least one measurable lesion as assessed by the IRRC according to RECIST 1.1. 7.Normal major organ functions as defined by the following criteria (no blood transfusions, or treatment with albumin, recombinant human thrombopoietin or colony-stimulating factor within 14 days prior to the first dose in this study): a) Hemoglobin (Hb) = 90 g/L; Absolute neutrophil count (ANC)=1.5×109/LPlatelet (PLT)=100×109/Lleucocyte count(WBC)=3.0×109/Lb)ALT/AST=2.5×ULN or = 5×ULN for patients with liver metastasesbilirubin=1.5×ULN or=3×ULN for patients with liver metastasesc) Creatinine (Cr)=1.5x ULN or creatinine clearance>60 ml/min(Calculted using the Cockcroft-Gault formula). 8.An expected survival = 3 months. 9.Female patients must meet one of the following conditions: a.Menopause (defined as no menses for at least 1 year and no confirmed cause other than menopause), or b.Surgically sterilized (removal of the ovaries and/or uterus), or c.Of child-bearing potential, but must meet the following: oSerum pregnancy test must be negative within 7 days prior to randomization, and oAgree to use birth control methods with an annual failure rate of <1% or maintain abstinence (avoid heterosexual intercourse) (from the signing of ICF to at least 6 months after the final dose of study drug) (birth control methods with an annual failure rate of <1% include bilateral tubal ligation, male sterilization, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine contraceptive devices and coppercontaining intrauterine contraceptive devices or condoms), and oMust not be breast-feeding. 10.Male patients must: agree to abstinence (avoid heterosexual intercourse) or take contraception measures as follows: male patients with a pregnant partner or a partner of childbearing potential must remain abstinent or use a condom to prevent embryonic exposure during study treatment and for at least 6 months after the last dose of study drug. Periodic abstinence (e.g., contraceptive methods based on calendar day, ovulation, basal body temperature or post-ovulation) and external ejaculation are ineligible methods of contraception.
Exclusion criteria
Exclusion criteria: 1.The subject has previously received other antibodies/drugs against immune checkpoints, such as PD-1, PD-L1, CTLA4, etc. 2.Patients who are preparing for or have received an organ or bone marrow transplant. 3.Patients with known or documented active CNS metastases and/or carcinomatous meningitis at screening. However, the following subjects are allowed to be enrolled: 1) Subjects with asymptomatic brain metastases (i.e., no progressive central nervous system symptoms caused by brain metastases, no requirement for corticosteroids, and lesion size = 1.5?cm) may be included, but are required to receive regular brain imaging as a site of lesion. 2) Subjects with treated brain metastases which have been stable for at least 2 weeks. 4.Patients with myocardial infarction within half a year before the first dose of the study drug, poorly controlled arrhythmia (including QTc intervals = 450 ms for males and = 470 ms for females) (QTc intervals are calculated by Fridericia's formula). 5.Class III to IV cardiac insufficiency according to NYHA classification or a left ventricular ejection fraction 100IU/mL for HBV-DNA) or Hepatitis C (positive tests for HCV antibody and HCV-RNA). Hepatitis B and C co-infection (positive test for HBsAg or HBcAb and positive test for HCV antibody). 8.Known active or suspected autoimmune diseases. Subjects in a stable state with no need for systemic immunosuppressant therapy are allowed to enroll. 9.Participation in any other ongoing clinical studies, or less than 14 days from the end of the previous clinical study treatment to the start of this trial. 10.Known history of severe allergy to any monoclonal antibody. 11.Known hypersensitivity to carboplatin or etoposide. 12.Pregnant or lactating women. 13.Known history of psychotropics abuse or drug abuse. 14.Pleural or pericardial effusion requiring clinical intervention, or ascites. 15.Patients with uncontrolled diabetes mellitus. 16.A medical history of other malignancies within the past 5 years 17.As the investigator judged, the subject had other factors that may contribute to the early termination of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate(ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (DOR);Progression-free survival (PFS);Overall Survival (OS);Disease control rate (DCR); | — |
Countries
China
Contacts
Public ContactCheng Ying
Jilin Provincial Tumor Hospital
Outcome results
None listed