Teniposide, Cisplatin and Serplulimab for Treatment of ES-SCLC, a Randomized Controlled Study

Official title

Comparison of Teniposide, Cisplatin and Serplulimab Regimen With Etoposide, Cisplatin and Serplulimab Regimen for Treatment of Extensive Stage Small Lung Cancer, a Random, Open Label, Positive Control, Multicenter Study

Overview

To compare the efficacy and safety between teniposide, cisplatin and serplulimab regimen and etoposide, cisplatin and serplulimab regimen in the treatment of extensive stage small lung cancer

Detailed description

Two arms trial, PFS for outcome, for patients in extensive stage of SCLC

Interventions

• Drug Teniposide
  To evaluate the efficacy and safety of teniposide regimen
• Drug Etoposide
  For comparison
• Drug serplulimab
  Fixed regimen
• Drug cisplatin
  Fixed regimen

Primary outcome measures

• Progression Free Survival [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

• Has not received systematic treatment for extensive stage small cell lung cancer in the past
• Extensive stage small cell lung cancer patients who have been pathologically proven to be intolerant to synchronous radiotherapy and chemotherapy
• Patients who have previously received radiotherapy and chemotherapy for limited stage SCLC and have had an untreatable interval of at least 6 months from the end of systemic treatment to SCLC recurrence
• Lesions can only be considered measurable if there is clear progression of a previously irradiated lesion after radiotherapy, and the previously irradiated lesion is not the only one
• Age≥18 years
• ECOG: 0-1
• Expected survival time exceeds 3 months
• Hb≥100g/L; ANC≥1.5×109/L; PLT≥100×109/L; WBC≥3.0×109/L; ALT and AST≤2.5×ULN(with tumor liver metastases, ≤5×ULN); TBIL≤1.5×ULN(with tumor liver metastases,≤3×ULN); Cr≤1.5×ULN or EGFR≥50ml/min; APTT, INR, PT≤1.5×ULN; LVEF≥50%
• Women of childbearing age should agree to use contraceptive measures during the study period and within 6 months after the end of the study. Serum pregnancy test negative within 28 days prior to enrollment in the study, and must be a non lactating subject. Men should be subjects who agree to use contraception during the study period and within 6 months after the end of the study period
• The subjects should sign an informed consent form and had good compliance

Exclusion criteria

• Patients with unstable or clinically symptomatic brain metastases, including those with central symptoms, brain edema, and those requiring radiation therapy
• Active autoimmune diseases that require systemic treatment (such as the use of disease relieving drugs, corticosteroids, or immunosuppressants) within the two years prior to enrollment
• Diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose>10mg/day prednisone or other effective hormones), and continuing to use within 2 weeks prior to enrollment
• Within 5 years, the subject has previously or simultaneously suffered from other malignant tumors that have not been cured
• With multiple factors that affect oral medication, such as inability to swallow, postoperative gastrointestinal resection, chronic diarrhea, and intestinal obstruction
• Uncontrollable pleural effusion, pericardial effusion, or ascites that require repeated drainage
• Spinal cord compression that cannot be cured or relieved by surgery and/or radiotherapy, or previously diagnosed spinal cord compression with no clinical evidence of disease stabilization for ≥ 1 week before enrollment after treatment
• Within 2 weeks prior to enrollment, there was significant hemoptysis
• Subjects who did not recover to ≤ CTCAE v5.0 level 1 due to adverse events caused by previous treatment (excluding hair loss)
• Received significant surgical treatment or significant traumatic injury within 28 days prior to enrollment
• Serious arterial/venous thrombotic events, such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism, occurred within the 6 months prior to enrollment
• Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders
• Subjects with poor blood pressure control (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg) (excluding patients who were able to control blood pressure with dual drugs before enrollment); 2) Suffering from grade I or above myocardial ischemia or infarction, arrhythmia (including male QTc ≥ 450ms (male), QTc ≥ 470ms (female)), and ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification); 3) Active or uncontrolled severe infection (≥ CTCAE v5.0 level 2 infection); 4) Cirrhosis, active hepatitis \[known carriers of hepatitis B virus (HBV) must exclude active HBV infection, i.e. HBV DNA positive (>1 × 104 copies/mL or>2000 IU/ml); Known hepatitis C virus infection (HCV) and HCV RNA positivity (>1 × 103 copies/mL, or other types of hepatitis or cirrhosis; 5) HIV test positive; 6) Urine routine indicates that urine protein is ≥ 3+, and it is confirmed that 24-hour urine protein quantification is greater than 3.0g;
• No blood transfusion, albumin therapy, recombinant human thrombopoietin or colony stimulating factor (CSF) treatment was performed within 14 days prior to the first dose in this study
• According to the researcher's judgment, there are accompanying diseases that seriously endanger the safety of the subjects or affect the completion of the study by the patients

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• SUN-YAT-SEN University Cancer Center — Guangzhou

Identifiers

NCT: NCT07583511 · TNBG-IIT001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗