Pulmonary Neuroendocrine Carcinoma
Conditions
Interventions
Stage 1:Serplulimab 300 mg on Day 1,IV
Stage 1:Etoposide 100 mg/m^2 on Days 1-3,IV
Stage 1:Carboplatin AUC = 5, on Day 1,IV
Stage 2:Serplulimab 300 mg on Day 1,IV
Stage 2:Etoposide 100 mg/m^2 on Days 1-3,IV
Stage 2:Carboplatin AUC = 5, on Day 1,IV
Sponsors
PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Voluntary participation in a clinical study. 2.Male or female subjects aged 18 to 75 years (inclusive) at the time of informed consent (ICF). 3.Subjects with histopathologically or cytologically confirmed neuroendocrine carcinoma of the lung. 4.No known EGFR sensitive mutations or ALK, ROS1 gene rearrangements. 5.No prior first-line systemic therapy or anti-PD-1/L1, CTLA-4 therapy. 6.At least one measurable target lesion as assessed by the investigator per RECIST v1.1 within 4 weeks prior to the first dose. 7.ECOG PS score of 0 or 1. 8.Expected survival >= 12 weeks. 9.Adequate vital organ function. 10.Female patients must meet one of the following conditions: a.Menopause (defined as no menses for at least 1 year and no other confirmed cause other than menopause), or b.Have been surgically sterilized (removal of ovaries and/or uterus), or c.Childbearing potential, but must meet: i.Serum pregnancy test must be negative within 3 days prior to dosing, and ii.Agree to practice birth control with an annual failure rate of < 1% or remain abstinent (refrain from heterosexual intercourse) (from signing of the ICF until at least 6 months after the last dose of study drug) (methods of birth control with an annual failure rate of < 1% include bilateral tubal ligation, male sterilization, correct use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper containing intrauterine devices or condoms), AND iii.Do not breastfeed. 11.Male patients must meet: Agree to practice sexual abstinence (to avoid heterosexual intercourse) or use contraception as specified below: Male patients must remain abstinent or use a condom to prevent embryogenic drug exposure during study treatment and for at least 6 months after the last dose of study drug when their partner is a woman of childbearing potential or when their partner is pregnant. Periodic abstinence (e.g., calendar day, ovulation, basal body temperature, or post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Exclusion criteria
Exclusion criteria: 1.Histology of squamous or non-squamous NSCLC. Mixed tumors will be classified by predominant cell type. Patients were not eligible for enrollment if they had a small cell component, a squamous component, or a non-squamous component of NSCLC. 2.Known history of severe allergy to any monoclonal antibody (NCI-CTCAE 5.0 grade greater than 3); or known hypersensitivity to carboplatin/etoposide components. 3.Any of the following conditions at the screening/baseline examination: a.Any active infection requiring systemic anti-infective therapy within 14 days prior to the first dose or subject has a positive RT-PCR test for SARS-CoV-2 infection at randomization. Subjects with a history of COVID-19 infection must have a negative RT-PCR test prior to the first dose; b.Myocardial infarction, poorly controlled arrhythmia (including QTc interval >= 450 ms for males and >= 470 ms for females) (QTc interval calculated by Fridericia formula) within 6 months prior to the first dose; or Class III-IV cardiac insufficiency according to NYHA criteria or left ventricular ejection fraction = grade 2; e.Subject has uncontrolled or symptomatic hypercalcemia (> 1.5 mmol/L ionized calcium or calcium > 12 mg/dL or corrected serum calcium > ULN); f.Subjects with previous and screening interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia and severely impaired pulmonary function that may interfere with the detection and treatment of suspected drug-related pulmonary toxicity; g.Patients with active or latent pulmonary tuberculosis (etiological test is positive); or patients with hepatitis B [hepatitis B surface antigen (HBsAg) positive and HBV-DNA test indicates viral replication, viral load > 500 IU/ml]; or patients with hepatitis C [hepatitis C virus (HCV) antibody positive and HCV-RNA test indicates viral replication]; or patients with syphilis screening positive (except patients with positive specific antibody test, negative non-specific antibody test and confirmed as inactive infection in combination with clinical judgment); or patients with known positive history of human immunodeficiency virus (HIV) or positive HIV screening; h.Subject has known active or suspected autoimmune disease. Subjects in a stable state who do not require systemic immunosuppressive therapy are allowed to be enrolled; i.Other active malignancy within 5 years or concurrently. Localized tumors that have been cured for more than 5 year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS);Overall survival;Duration of Response (DOR);Adverse Events; | — |
Countries
China
Contacts
Public ContactYi Hu
PLA General Hospital
Outcome results
None listed